Side effects of lovenox

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Lovenox

SIDE EFFECTS

The following serious adverse reactions are also discussed in other sections of the labeling:

  • Spinal/epidural hematomas
  • Increased Risk of Hemorrhage
  • Thrombocytopenia

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

During clinical development for the approved indications, 15,918 patients were exposed to Lovenox. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1,578 for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, 10,176 for treatment of acute ST-elevation myocardial infarction, and 857 for treatment of deep vein thrombosis with or without pulmonary embolism. Lovenox doses in the clinical trials for prophylaxis of deep vein thrombosis following abdominal or hip or knee replacement surgery or in medical patients with severely restricted mobility during acute illness ranged from 40 mg subcutaneously once daily to 30 mg subcutaneously twice daily. In the clinical studies for prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction doses were 1 mg/kg every 12 hours and in the clinical studies for treatment of acute ST-segment elevation myocardial infarction Lovenox doses were a 30 mg intravenous bolus followed by 1 mg/kg every 12 hours subcutaneously.

Hemorrhage

The following rates of major bleeding events have been reported during clinical trials with Lovenox (see Tables 2 to 7).

Table 2: Major Bleeding Episodes Following Abdominal and Colorectal Surgery*

Indications Dosing Regimen
Lovenox 40 mg daily subcutaneously Heparin 5000 U q8h subcutaneously
Abdominal Surgery n=555 n=560
23 (4%) 16 (3%)
Colorectal Surgery n=673 n=674
28 (4%) 21 (3%)
* Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.

Table 3: Major Bleeding Episodes Following Hip or Knee Replacement Surgery*

Indications Dosing Regimen
Lovenox 40 mg daily subcutaneously Lovenox 30 mg q12h subcutaneously Heparin 15,000 U/24h subcutaneously
Hip Replacement Surgery without Extended Prophylaxis† n=786
31 (4%)
n=541
32 (6%)
Hip Replacement Surgery with Extended Prophylaxis
Peri-operative Period‡ n=288
4 (2%)
Extended Prophylaxis Period§ n=221
0 (0%)
Knee Replacement Surgery without Extended Prophylaxis† n=294
3 (1%)
n=225
3 (1%)
* Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial hemorrhages were always considered major. In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages.
† Lovenox 30 mg every 12 hours subcutaneously initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery
‡ Lovenox 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery
§ Lovenox 40 mg subcutaneously once a day for up to 21 days after discharge
NOTE: At no time point were the 40 mg once a day pre-operative and the 30 mg every 12 hours postoperative hip replacement surgery prophylactic regimens compared in clinical trials. Injection site hematomas during the extended prophylaxis period after hip replacement surgery occurred in 9% of the Lovenox patients versus 1.8% of the placebo patients.

Table 4: Major Bleeding Episodes in Medical Patients with Severely Restricted Mobility During Acute Illness*

Indication Dosing Regimen
Lovenox† 20 mg daily subcutaneously Lovenox† 40 mg daily subcutaneously Placebo†
Medical Patients During Acute Illness n=351 n=360 n=362
1 (<1%) 3 (<1%) 2 (<1%)
* Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, (2) if the hemorrhage caused a decrease in hemoglobin of ≥2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial hemorrhages were always considered major although none were reported during the trial.
† The rates represent major bleeding on study medication up to 24 hours after last dose.

Table 5: Major Bleeding Episodes in Deep Vein Thrombosis with or without Pulmonary Embolism Treatment*

Indication Dosing Regimen†
Lovenox 1.5 mg/kg daily subcutaneously Lovenox 1 mg/kg q12h subcutaneously Heparin aPTT Adjusted Intravenous Therapy
Treatment of DVT and PE n=298 n=559 n=554
5 (2%) 9 (2%) 9 (2%)
* Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.
† All patients also received warfarin sodium (dose-adjusted according to PT to achieve an INR of 2.0 to 3.0) commencing within 72 hours of Lovenox or standard heparin therapy and continuing for up to 90 days.

Table 6: Major Bleeding Episodes in Unstable Angina and Non-Q-Wave Myocardial Infarction

Indication Dosing Regimen
Lovenox* 1 mg/kg q12h subcutaneously Heparin* aPTT Adjusted Intravenous Therapy
Unstable Angina and Non-Q- Wave MI†,‡ n=1578 n=1529
17 (1%) 18 (1%)
* The rates represent major bleeding on study medication up to 12 hours after dose.
† Aspirin therapy was administered concurrently (100 to 325 mg per day).
‡ Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease by ≥3 g/dL or transfusion of 2 or more units of blood products. Intraocular, retroperitoneal, and intracranial hemorrhages were always considered major.

Table 7: Major Bleeding Episodes in Acute ST-Segment Elevation Myocardial Infarction

Indication Dosing Regimen
Lovenox* Initial 30 mg intravenous bolus followed by 1 mg/kg q12h subcutaneously Heparin* aPTT Adjusted Intravenous Therapy
Acute ST-Segment Elevation Myocardial Infarction n=10176 n=10151
n (%) n (%)
Major bleeding (including ICH)† 211 (2.1) 138 (1.4)
Intracranial hemorrhages (ICH) 84 (0.8) 66 (0.7)
* The rates represent major bleeding (including ICH) up to 30 days
† Bleedings were considered major if the hemorrhage caused a significant clinical event associated with a hemoglobin decrease by ≥5 g/dL. ICH were always considered major.

Elevations Of Serum Aminotransferases

Asymptomatic increases in aspartate (AST ) and alanine (ALT ) aminotransferase levels greater than three times the upper limit of normal of the laboratory reference range have been reported in up to 6.1% and 5.9% of patients, respectively, during treatment with Lovenox.

Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like Lovenox should be interpreted with caution.

Local Reactions

Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of Lovenox.

Adverse Reactions In Patients Receiving Lovenox For Prophylaxis Or Treatment Of DVT, PE

Other adverse reactions that were thought to be possibly or probably related to treatment with Lovenox, heparin, or placebo in clinical trials with patients undergoing hip or knee replacement surgery, abdominal or colorectal surgery, or treatment for DVT and that occurred at a rate of at least 2% in the Lovenox group, are provided below (see Tables 8 to 11).

Table 8: Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Patients Undergoing Abdominal or Colorectal Surgery

Adverse Reaction Dosing Regimen
Lovenox 40 mg daily subcutaneously
n=1228 %
Heparin 5000 U q8h subcutaneously
n=1234 %
Severe Total Severe Total
Hemorrhage <1 7 <1 6
Anemia <1 3 <1 3
Ecchymosis 0 3 0 3

Table 9: Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Patients Undergoing Hip or Knee Replacement Surgery

Adverse Reaction Dosing Regimen
Lovenox 40 mg daily subcutaneously Lovenox 30 mg q12h subcutaneously
n=1080 %
Heparin 15,000 U/24h subcutaneously
n=766 %
Placebo q12h subcutaneously
n=115 %
Peri-operative Period
n=288* %
Extended Prophylaxis Period
n=131† %
Severe Total Severe Total Severe Total Severe Total Severe Total
Fever 0 8 0 0 <1 5 <1 4 0 3
Hemorrhage <1 13 0 5 <1 4 1 4 0 3
Nausea <1 3 <1 2 0 2
Anemia 0 16 0 <2 <1 2 2 5 <1 7
Edema <1 2 <1 2 0 2
Peripheral edema 0 6 0 0 <1 3 <1 4 0 3
* Data represent Lovenox 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery in 288 hip replacement surgery patients who received Lovenox peri-operatively in an unblinded fashion in one clinical trial.
† Data represent Lovenox 40 mg subcutaneously once a day given in a blinded fashion as extended prophylaxis at the end of the peri-operative period in 131 of the original 288 hip replacement surgery patients for up to 21 days in one clinical trial.

Table 10: Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Medical Patients with Severely Restricted Mobility During Acute Illness

Adverse Reaction Dosing Regimen
Lovenox 40 mg daily subcutaneously
n=360 %
Placebo daily subcutaneously
n=362 %
Dyspnea 3.3 5.2
Thrombocytopenia 2.8 2.8
Confusion 2.2 1.1
Diarrhea 2.2 1.7
Nausea 2.5 1.7

Table 11: Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Patients Undergoing Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

Adverse Reaction Dosing Regimen
Lovenox 1.5 mg/kg daily subcutaneously
n=298 %
Lovenox 1 mg/kg q12h subcutaneously
n=559 %
Heparin aPTT Adjusted Intravenous Therapy
n=544 %
Severe Total Severe Total Severe Total
Injection Site Hemorrhage 0 5 0 3 <1 <1
Injection Site Pain 0 2 0 2 0 0
Hematuria 0 2 0 <1 <1 2

Adverse Events In Lovenox-Treated Patients With Unstable Angina Or Non-Q-Wave Myocardial Infarction

Non-hemorrhagic clinical events reported to be related to Lovenox therapy occurred at an incidence of ≤1%.

Non-major hemorrhagic events, primarily injection site ecchymosis and hematomas, were more frequently reported in patients treated with subcutaneous Lovenox than in patients treated with intravenous heparin.

Serious adverse events with Lovenox or heparin in a clinical trial in patients with unstable angina or non-Q-wave myocardial infarction that occurred at a rate of at least 0.5% in the Lovenox group are provided below (see Table 12).

Table 12: Serious Adverse Events Occurring at ≥0.5% Incidence in Lovenox-Treated Patients with Unstable Angina or Non-Q-Wave Myocardial Infarction

Adverse Reactions In Lovenox-Treated Patients With Acute ST-Segment Elevation Myocardial Infarction

In a clinical trial in patients with acute ST-segment elevation myocardial infarction, thrombocytopenia occurred at a rate of 1.5%.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of epidural or spinal hematoma formation with concurrent use of Lovenox and spinal/epidural anesthesia or spinal puncture. The majority of patients had a postoperative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis.

Local reactions at the injection site (e.g. nodules, inflammation, oozing), systemic allergic reactions (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions including shock), vesiculobullous rash, cases of hypersensitivity cutaneous vasculitis, purpura, skin necrosis (occurring at either the injection site or distant from the injection site), thrombocytosis, and thrombocytopenia with thrombosis have been reported.

Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, hematoma in body tissues). Very rare cases of hyperlipidemia have also been reported, with one case of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined.

Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported.

Osteoporosis has also been reported following long-term therapy.

Read the entire FDA prescribing information for Lovenox (Enoxaparin Sodium Injection)

Generic Name: enoxaparin (ee NOX a PAR rin)
Brand Names: Lovenox

Medically reviewed by Sanjai Sinha, MD Last updated on Aug 1, 2019.

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What is Lovenox?

Lovenox (enoxaparin) is an anticoagulant that helps prevent the formation of blood clots.

Lovenox is used to treat or prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery, or in people who are bed-ridden due to a prolonged illness.

Lovenox is also used to prevent blood vessel complications in people with certain types of angina (chest pain) or heart attack.

Important Information

You should not use Lovenox if you have active bleeding, or a low level of platelets in your blood after testing positive for a certain antibody while using enoxaparin.

Lovenox can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, a history of spinal surgery or repeated spinal taps, or if you are using other drugs that can affect blood clotting, including blood thinners or NSAIDs (ibuprofen, Advil, Aleve, and others). This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Before taking this medicine

You should not use Lovenox if you are allergic to enoxaparin, heparin, benzyl alcohol, or pork products, or if you have:

  • active or uncontrolled bleeding; or

  • if you had decreased platelets in your blood after testing positive for a certain antibody while using Lovenox within the past 100 days.

Lovenox may cause you to bleed more easily, especially if you have:

  • a bleeding disorder that is inherited or caused by disease;

  • hemorrhagic stroke;

  • an infection of the lining of your heart (also called bacterial endocarditis);

  • stomach or intestinal bleeding or ulcer; or

  • recent brain, spine, or eye surgery.

Lovenox can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term or permanent paralysis, and may be more likely to occur if:

  • you have a spinal cord injury;

  • you have a spinal catheter in place or if a catheter has been recently removed;

  • you have a history of spinal surgery or repeated spinal taps;

  • you have recently had a spinal tap or epidural anesthesia;

  • you take aspirin or an NSAID (nonsteroidal anti-inflammatory drug) – ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or

  • you are using a blood thinner (warfarin, Coumadin) or other medicines to treat or prevent blood clots.

Tell your doctor if you have ever had:

  • a bleeding disorder such as hemophilia;

  • kidney or liver disease;

  • uncontrolled high blood pressure;

  • eye problems caused by diabetes;

  • a stomach ulcer; or

  • low blood platelets after receiving heparin.

Tell your doctor if you are pregnant. If you use Lovenox during pregnancy, make sure your doctor knows if you have a mechanical heart valve.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I use Lovenox?

Lovenox is usually given every day until your bleeding condition improves. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Lovenox is injected under the skin, or as an infusion into a vein. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Lovenox if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors, or has particles in it. Call your pharmacist for new medicine.

You should be sitting or lying down during the injection. Do not inject this medicine into a muscle.

Your care provider will show you where on your body to inject Lovenox. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You will need frequent medical tests to help your doctor determine how long to treat you with Lovenox.

If you need surgery or dental work, tell your surgeon or dentist you currently use this medicine. You may need to stop for a short time.

Store at room temperature away from moisture and heat.

Each single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

After your first use of an Lovenox vial (bottle), you must use the medicine within 28 days. Throw away the vial after 28 days.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause excessive bleeding.

What should I avoid while using Lovenox?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Lovenox side effects

Get emergency medical help if you have signs of an allergic reaction to Lovenox: hives; itching or burning skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • unusual bleeding, or any bleeding that will not stop;

  • easy bruising, purple or red spots under your skin;

  • nosebleeds, bleeding gums;

  • abnormal vaginal bleeding, blood in your urine or stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • signs of bleeding in the brain – sudden weakness (especially on one side of the body), sudden severe headache, problems with speech or vision; or

  • low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Lovenox side effects may include:

  • nausea, diarrhea;

  • anemia;

  • confusion; or

  • pain, bruising, redness, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lovenox?

Tell your doctor about all your other medicines, especially other medicines to treat or prevent blood clots, such as:

  • abciximab, anagrelide, cilostazol, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;

  • alteplase, reteplase, tenecteplase, urokinase;

  • apixaban, argatroban, bivalirudin, dabigatran, desirudin, fondaparinux, lepirudin, rivaroxaban, tinzaparin; or

  • heparin.

This list is not complete. Other drugs may interact with enoxaparin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Lovenox only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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This information will teach you how to prepare and give an injection (shot) of blood thinning medication in a prefilled syringe. For the rest of this resource, our use of the words “you,” “your,” and “yourself” refers to you or your child.

You’ll need to give yourself injections (shots) of blood thinning medication. You’ll get prefilled syringes with the medications already in them from your pharmacy. You’ll use a small, short needle to inject the medication into the fat right under your skin.

Your prefilled syringe may come with a needle already attached, or you may need to attach it yourself. If your syringe doesn’t come with the needle attached, follow the instructions for attaching it in the “Preparing the Injection” section.

You’ll practice preparing and giving the injection with your nurse. When you’re at home, use this resource the first few times you give yourself the injections.

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Medication Information

Medication: _______________________________________
Medication schedule: _________________________________
Dose and amount: ___________________________________

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Preparing the Injection

  1. Prepare a clean area to set up your supplies, such as a kitchen table. Don’t use the bathroom as a work area. Line the area with clean, dry, disposable towels.
  2. Check for the correct name and dosage of medication on the prefilled syringe.
    • For pediatric patients, you may need to waste some of the dosage in the prefilled syringe, according to pharmacy instructions. Your child’s nurse will review this with you before you go home.
  3. Gather your supplies:
    • Prefilled syringe and a 27 gauge 1/2-inch needle or
    • Prefilled syringe with the needle attached
    • 2 alcohol pads
    • Disposable sharps container, such as an empty plastic bleach or detergent bottle with a cap labeled “Home Sharps-Not for Recycling.”
    • 2 x 2 gauze pad or cotton ball
    • Bandage
  4. Clean your hands:
    • If you’re washing your hands with soap and water, wet your hands, put soap on them, then rub them together for 15 seconds, and rinse. Dry your hands with a disposable towel, and use that same towel to turn off the faucet.
    • If you’re using an alcohol-based hand sanitizer, be sure to cover all surfaces of your hands with it, including in between your fingers, rubbing them together until they’re dry.
  5. Check to see if the syringe has a built-in needle. If it doesn’t, follow the steps below to put a needle on the syringe.

Attaching the needle:

  1. Open the package with the fresh needle, but don’t take out the needle yet. Put the open package on your work area
  2. Remove the black cap on the tip of the syringe. Don’t let anything, including your fingers, touch the tip once the cap is off. If anything touches the tip of the syringe, you must throw it away.
  3. Remove the needle from its package. Don’t remove the protective cap from the needle. Do not let anything, including your fingers, touch the needle. If anything touches the needle, you must throw it away in the sharps container.
  4. Twist the needle onto the base of the syringe using a clockwise (to the right) motion.

Figure 1. Choosing an injection site

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Giving the Injection

  1. Check to make sure that the syringe has the correct amount of medication. Don’t worry if there are tiny air bubbles in the syringe.
  2. Choose an injection site from the areas shown in Figure 1. Keep track of which site you used last and give the injection at a different site each time. Rotate sites according to a schedule. Don’t use an area that’s less than 2 inches (about 5 centimeters) from a scar, cut or wound.
  3. Remove or fold back any clothing that covers the injection site.
  4. Use the alcohol wipe to clean the area where you’re going to give the injection. Let it air dry. Don’t fan or blow on the area.
  5. Pick up the syringe with your dominant hand (the hand you write with). Using your other hand, take the protective cap off the needle. Don’t let anything, including your fingers, touch the needle. If anything touches the needle, you must throw it away in the sharps container. See the instructions in the section “What to Do if Anything Touches the Needle.”
  6. Hold the syringe like you would hold a dart (in between with your index and middle finger and thumb).
  7. Using your non-dominant hand (the hand you don’t write with), pinch a 1 to 2 inch (2 ½ to 5 centimeters) fold of skin near the injection site between your thumb and first finger. Keep the syringe in your other hand.
  8. Insert the needle into the skin in one quick motion at a 90-degree (straight up and down) angle (see Figures 2 and 3).

    Figure 2. Giving the injection

    Figure 3. Inserting the needle

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What to Do if Anything Touches the Needle

If you are using a syringe with a built-in needle, throw it into your sharps container. Start the process again with a new prefilled syringe.

  • If you need to throw away a syringe with a built-in needle, you’ll need to replace the medication. Call your doctor for a prescription.
  • If the needle and syringe were not attached, change the needle using the following steps:
  1. Remove the old needle from the syringe by twisting the base of the needle counter-clockwise (to the left, see Figure 4).
    • If you have trouble twisting it, carefully recap the needle. Then twist it again.

    Figure 4. Twisting the base of the needle

  2. After you remove the needle, place it in your sharps container. Don’t let anything touch the base of the syringe.
  3. Take the new capped needle out of the package. Attach it to the syringe by twisting it clockwise (to the right).

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Storing Your Medical Sharps

  • Use an empty plastic container with a screw-on cap, such as a laundry detergent bottle.
    • Pick a container that’s strong enough that needles can’t poke through the sides.
    • Pick a container that isn’t breakable.
    • Don’t store your sharps in glass bottles, soda bottles, milk jugs, aluminum cans, coffee cans, or paper or plastic bags.
  • Clearly label the container “Home Sharps – Not for Recycling.” Keep it away from children and pets.
  • Put the sharps in the container point-first as soon as you use them.
  • Don’t overfill the container. When it’s more than half full, stop using it. Wrap the cap with strong tape to create a more secure seal and prevent it from leaking.
  • Keep the container separate from trash that will be recycled.

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Getting Rid of Your Medical Sharps

  • If you live in New York or New Jersey, you can put the sealed container out with your regular trash for collection. Don’t put it in with your recyclables.
  • If you live in a different state, check with your local department of health for instructions.
  • Don’t put the sharps container in with your regular household trash. It should be placed next to your trash, in a container clearly labeled “home sharps.”

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Lovenox is the brand name for enoxaparin, a blood-thinning or anticoagulant drug used to prevent and treat blood clots.

Lovenox is often used to prevent blood clots in the legs, known as deep venous thrombosis (DVT). In DVT, the clots can travel from the legs to the lungs and can be life-threatening.

Lovenox is also used to prevent blood clots after hip or knee replacement surgery or abdominal surgery. During these post-op times, clots are most likely to form.

The medicine is also used to prevent blood clots in the heart arteries during heart attacks.

Besides being used as a preventive medicine, Lovenox is also used to treat DVT once it occurs, sometimes together with a blood thinner, warfarin (Coumadin).

The Food and Drug Administration (FDA) approved Lovenox, made by Sanofi, in 1993. The drug is made from heparin, which is a blood thinner, and includes an active ingredient made up of a complex mixture of sugar molecules.

In 2010, the FDA approved the first generic version of the drug, made by Sandoz Inc.

Lovenox is injected subcutaneously or given intravenously (IV).

Lovenox Warnings

Lovenox carries a black-box warning explaining that its use in patients who have spinal or epidural anesthesia or spinal puncture carries an increased risk of bleeding and bruising. This bleeding and bruising may lead to long-term or permanent paralysis.

If you are on Lovenox, you will need to have blood tests periodically to see how well it is working.

Every doctor or dentist you go to should know you are taking Lovenox. If you are about to have a medical or dental procedure, ask if you should discontinue Lovenox beforehand.

The medicine carries a risk of bleeding problems even if you don’t have anesthesia or a spinal puncture. If you notice any unusual bleeding, or bruising, tell your doctor.

Ask your dentist how best to clean your teeth and gums so you don’t experience excessive bleeding.

If you fall, have a blow to the head or your body, or have recently had a baby, be sure your primary doctor knows. All of these events could increase the risk of excess bleeding while on Lovenox.

Be sure your doctor knows all your medicines. Don’t start a new one, even an over-the-counter (OTC) medicine, vitamin or herbal medicine, without your doctor’s approval.

Pregnancy and Lovenox

Lovenox is in Pregnancy Category B, according to the FDA, meaning that animal studies have not revealed evidence of harm to the developing baby but no adequate studies have been done in pregnant women.

Talk to your doctor about whether it’s safe to take Lovenox while pregnant.

No adequate studies have been done on the use of Lovenox while breastfeeding. Ask your doctor whether it’s safe to breastfeed while taking it.

FDA Approves First Generic Enoxaparin Sodium Injection

The National Blood Clot Alliance (NBCA) is alerting its membership that the Food and Drug Administration (FDA) has approved a generic enoxaparin sodium injection (Sandoz/Momenta). Randy Fenninger, President of the National Blood Clot Alliance said, “The approval of this generic offers the potential for greater affordability for patients in need of this blood thinner.” Any questions that patients may have concerning this generic product should be discussed with their treating physicians.

The following is the July 23, 2010 release from the FDA:

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used for multiple indications including prevention of deep vein thrombosis (DVT), a potentially deadly blood clotting condition.

Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.

“Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, Ph.D., deputy director of the FDA’s Office of Pharmaceutical Science.

Prior to the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection. After carefully reviewing the petition, the agency determined that current scientific evidence, precedent, and FDA’s legal authority establish a sound basis for the approval of generic enoxaparin sodium injection. A response to the petition was released by the agency today.

Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh. Preventing these blood clots can prevent a pulmonary embolism, which is a sudden, potentially fatal, blockage in a lung artery that can occur if the blood clot breaks free and travels through the bloodstream to the lungs.

According to the National Heart, Lung, and Blood Institute, at least 100,000 cases of pulmonary embolism occur each year in the United States. It is the third most common cause of death among hospitalized patients. This medicine is also used to prevent blood clots in patients confined to bed and also for patients experiencing chest pain and heart attacks.

The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and bruising (hematoma), which may cause long-term or permanent paralysis.

Approval of generic enoxaparin sodium injection has been granted to Sandoz Inc. of Broomfield, Colo. The generic product has been approved in the following strengths: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL, and 150 mg/mL. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

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CLINICAL PHARMACOLOGY

Mechanism Of Action

Enoxaparin is a low molecular weight heparin which has antithrombotic properties.

Pharmacodynamics

In humans, enoxaparin given at a dose of 1.5 mg/kg subcutaneously is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (mean ±SD, 14.0±3.1) (based on areas under anti-Factor activity versus time curves) compared to the ratios observed for heparin (mean ±SD, 1.22±0.13). Increases of up to 1.8 times the control values were seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT). Enoxaparin at a 1 mg/kg dose (100 mg/mL concentration), administered subcutaneously every 12 hours to patients in a large clinical trial resulted in aPTT values of 45 seconds or less in the majority of patients (n=1607). A 30 mg intravenous bolus immediately followed by a 1 mg/kg subcutaneous administration resulted in aPTT postinjection values of 50 seconds. The average aPTT prolongation value on Day 1 was about 16% higher than on Day 4.

Pharmacokinetics

Absorption

Pharmacokinetic trials were conducted using the 100 mg/mL formulation. Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3 to 5 hours after subcutaneous injection of enoxaparin. Mean peak anti-Factor Xa activity was 0.16 IU/mL (1.58 mcg/mL) and 0.38 IU/mL (3.83 mcg/mL) after the 20 mg and the 40 mg clinically tested subcutaneous doses, respectively. Mean (n=46) peak anti-Factor Xa activity was 1.1 IU/mL at steady state in patients with unstable angina receiving 1 mg/kg subcutaneously every 12 hours for 14 days. Mean absolute bioavailability of enoxaparin, after 1.5 mg/kg given subcutaneously, based on anti-Factor Xa activity is approximately 100% in healthy subjects.

A 30 mg intravenous bolus immediately followed by 1 mg/kg subcutaneously every 12 hours provided initial peak anti-Factor Xa levels of 1.16 IU/mL (n=16) and average exposure corresponding to 84% of steady-state levels. Steady state is achieved on the second day of treatment.

Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges . After repeated subcutaneous administration of 40 mg once daily and 1.5 mg/kg once-daily regimens in healthy volunteers, the steady state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose. Steady-state enoxaparin activity levels are well predicted by single-dose pharmacokinetics. After repeated subcutaneous administration of the 1 mg/kg twice-daily regimen, the steady state is reached from day 4 with mean exposure about 65% higher than after a single dose and mean peak and trough levels of about 1.2 and 0.52 IU/mL, respectively. Based on enoxaparin sodium pharmacokinetics, this difference in steady state is expected and within the therapeutic range.

Although not studied clinically, the 150 mg/mL concentration of enoxaparin sodium is projected to result in anticoagulant activities similar to those of 100 mg/mL and 200 mg/mL concentrations at the same enoxaparin dose. When a daily 1.5 mg/kg subcutaneous injection of enoxaparin sodium was given to 25 healthy male and female subjects using a 100 mg/mL or a 200 mg/mL concentration the following pharmacokinetic profiles were obtained (see Table 13).

Table 13: Pharmacokinetic Parameters* After 5 Days of 1.5 mg/kg Subcutaneous Once-Daily Doses of Enoxaparin Sodium Using 100 mg/mL or 200 mg/mL Concentrations

Distribution

The volume of distribution of anti-Factor Xa activity is about 4.3 L.

Elimination

Following intravenous dosing, the total body clearance of enoxaparin is 26 mL/min. After intravenous dosing of enoxaparin labeled with the gamma-emitter, 99mTc, 40% of radioactivity and 8 to 20% of anti-Factor Xa activity were recovered in urine in 24 hours. Elimination half-life based on anti-Factor Xa activity was 4.5 hours after a single subcutaneous dose to about 7 hours after repeated dosing. Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg subcutaneous once a day dose.

Following subcutaneous dosing, the apparent clearance (CL/F) of enoxaparin is approximately 15 mL/min.

Metabolism

Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency. Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose.

Special Populations

Gender

Apparent clearance and Amax derived from anti-Factor Xa values following single subcutaneous dosing (40 mg and 60 mg) were slightly higher in males than in females. The source of the gender difference in these parameters has not been conclusively identified; however, body weight may be a contributing factor.

Geriatric

Apparent clearance and Amax derived from anti-Factor Xa values following single and multiple subcutaneous dosing in geriatric subjects were close to those observed in young subjects. Following once a day subcutaneous dosing of 40 mg enoxaparin, the Day 10 mean area under anti-Factor Xa activity versus time curve (AUC) was approximately 15% greater than the mean Day 1 AUC value .

Renal Impairment

A linear relationship between anti-Factor Xa plasma clearance and creatinine clearance at steady state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function. Anti-Factor Xa exposure represented by AUC, at steady state, is marginally increased in patients with creatinine clearance 50 to 80 mL/min and patients with creatinine clearance 30 to <50 mL/min renal impairment after repeated subcutaneous 40 mg once-daily doses. In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at steady state is significantly increased on average by 65% after repeated subcutaneous 40 mg once-daily doses .

Hemodialysis

In a single study, elimination rate appeared similar but AUC was two-fold higher than control population, after a single 0.25 or 0.5 mg/kg intravenous dose.

Hepatic Impairment

Studies with Lovenox in patients with hepatic impairment have not been conducted and the impact of hepatic impairment on the exposure to enoxaparin is unknown.

Weight

After repeated subcutaneous 1.5 mg/kg once-daily dosing, mean AUC of anti-Factor Xa activity is marginally higher at steady state in obese healthy volunteers (BMI 30-48 kg/m²) compared to non-obese control subjects, while Amax is not increased.

When non–weight-adjusted dosing was administered, it was found after a single-subcutaneous 40 mg dose, that anti-Factor Xa exposure is 52% higher in low-weight women (<45 kg) and 27% higher in low-weight men (<57 kg) when compared to normal weight control subjects .

Pharmacokinetic Interaction

No pharmacokinetic interaction was observed between Lovenox and thrombolytics when administered concomitantly.

Animal Toxicology And/Or Pharmacology

A single subcutaneous dose of 46.4 mg/kg enoxaparin was lethal to rats. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea, cyanosis, and coma.

Reproductive And Developmental Toxicology

Teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 30 mg/kg/day corresponding to 211 mg/m²/day and 410 mg/m²/day in rats and rabbits respectively. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin.

Clinical Studies

Prophylaxis Of Deep Vein Thrombosis Following Abdominal Surgery In Patients At Risk For Thromboembolic Complications

Abdominal surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes or who have additional risk factors such as malignancy or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE).

In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of 1116 patients were enrolled in the study, and 1115 patients were treated. Patients ranged in age from 32 to 97 years (mean age 67 years) with 52.7% men and 47.3% women. Patients were 98% Caucasian, 1.1% Black, 0.4% Asian and 0.4% others. Lovenox 40 mg subcutaneously, administered once a day, beginning 2 hours prior to surgery and continuing for a maximum of 12 days after surgery, was comparable to heparin 5000 U every 8 hours subcutaneously in reducing the risk of DVT. The efficacy data are provided below (see Table 14).

Table 14: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery

In a second double-blind, parallel group study, Lovenox 40 mg subcutaneously once a day was compared to heparin 5000 U every 8 hours subcutaneously in patients undergoing colorectal surgery (one-third with cancer). A total of 1347 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 50.1 years) with 54.2% men and 45.8% women. Treatment was initiated approximately 2 hours prior to surgery and continued for approximately 7 to 10 days after surgery. The efficacy data are provided below (see Table 15).

Table 15: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis Following Colorectal Surgery

Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery

Lovenox has been shown to reduce the risk of postoperative deep vein thrombosis (DVT) following hip or knee replacement surgery.

In a double-blind study, Lovenox 30 mg every 12 hours subcutaneously was compared to placebo in patients with hip replacement. A total of 100 patients were randomized in the study and all patients were treated. Patients ranged in age from 41 to 84 years (mean age 67.1 years) with 45% men and 55% women. After hemostasis was established, treatment was initiated 12 to 24 hours after surgery and was continued for 10 to 14 days after surgery. The efficacy data are provided below (see Table 16).

Table 16: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis Following Hip Replacement Surgery

A double-blind, multicenter study compared three dosing regimens of Lovenox in patients with hip replacement. A total of 572 patients were randomized in the study and 568 patients were treated. Patients ranged in age from 31 to 88 years (mean age 64.7 years) with 63% men and 37% women. Patients were 93% Caucasian, 6% Black, <1% Asian, and 1% others. Treatment was initiated within two days after surgery and was continued for 7 to 11 days after surgery. The efficacy data are provided below (see Table 17).

Table 17: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis Following Hip Replacement Surgery

There was no significant difference between the 30 mg every 12 hours and 40 mg once a day regimens. In a double-blind study, Lovenox 30 mg every 12 hours subcutaneously was compared to placebo in patients undergoing knee replacement surgery. A total of 132 patients were randomized in the study and 131 patients were treated, of which 99 had total knee replacement and 32 had either unicompartmental knee replacement or tibial osteotomy. The 99 patients with total knee replacement ranged in age from 42 to 85 years (mean age 70.2 years) with 36.4% men and 63.6% women. After hemostasis was established, treatment was initiated 12 to 24 hours after surgery and was continued up to 15 days after surgery. The incidence of proximal and total DVT after surgery was significantly lower for Lovenox compared to placebo. The efficacy data are provided below (see Table 18).

Table 18: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis Following Total Knee Replacement Surgery

Additionally, in an open-label, parallel group, randomized clinical study, Lovenox 30 mg every 12 hours subcutaneously in patients undergoing elective knee replacement surgery was compared to heparin 5000 U every 8 hours subcutaneously. A total of 453 patients were randomized in the study and all were treated. Patients ranged in age from 38 to 90 years (mean age 68.5 years) with 43.7% men and 56.3% women. Patients were 92.5% Caucasian, 5.3% Black, and 0.6% others. Treatment was initiated after surgery and continued up to 14 days. The incidence of deep vein thrombosis was lower for Lovenox compared to heparin.

Extended Prophylaxis of Deep Vein Thrombosis Following Hip Replacement Surgery: In a study of extended prophylaxis for patients undergoing hip replacement surgery, patients were treated, while hospitalized, with Lovenox 40 mg subcutaneously, initiated up to 12 hours prior to surgery for the prophylaxis of postoperative DVT. At the end of the peri-operative period, all patients underwent bilateral venography. In a double-blind design, those patients with no venous thromboembolic disease were randomized to a post-discharge regimen of either Lovenox 40 mg (n=90) once a day subcutaneously or to placebo (n=89) for 3 weeks. A total of 179 patients were randomized in the double-blind phase of the study and all patients were treated. Patients ranged in age from 47 to 87 years (mean age 69.4 years) with 57% men and 43% women. In this population of patients, the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo. The efficacy data are provided below (see Table 19).

Table 19: Efficacy of Lovenox in the Extended Prophylaxis of Deep Vein Thrombosis Following Hip Replacement Surgery

In a second study, patients undergoing hip replacement surgery were treated, while hospitalized, with Lovenox 40 mg subcutaneously, initiated up to 12 hours prior to surgery. All patients were examined for clinical signs and symptoms of venous thromboembolic (VTE) disease. In a double-blind design, patients without clinical signs and symptoms of VTE disease were randomized to a post-discharge regimen of either Lovenox 40 mg (n=131) once a day subcutaneously or to placebo (n=131) for 3 weeks. A total of 262 patients were randomized in the study double-blind phase and all patients were treated. Patients ranged in age from 44 to 87 years (mean age 68.5 years) with 43.1% men and 56.9% women. Similar to the first study the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo, with a statistically significant difference in both total DVT (Lovenox 21 versus placebo 45 ; p=0.001) and proximal DVT (Lovenox 8 versus placebo 28 ; p=<0.001).

Prophylaxis Of Deep Vein Thrombosis In Medical Patients With Severely Restricted Mobility during Acute Illness

In a double blind multicenter, parallel group study, Lovenox 20 mg or 40 mg once a day subcutaneously was compared to placebo in the prophylaxis of deep vein thrombosis (DVT) in medical patients with severely restricted mobility during acute illness (defined as walking distance of <10 meters for ≤3 days). This study included patients with heart failure (NYHA Class III or IV); acute respiratory failure or complicated chronic respiratory insufficiency (not requiring ventilatory support): acute infection (excluding septic shock); or acute rheumatic disorder (acute lumbar or sciatic pain, vertebral compression , acute arthritic episodes of the lower extremities). A total of 1102 patients were enrolled in the study, and 1073 patients were treated. Patients ranged in age from 40 to 97 years (mean age 73 years) with equal proportions of men and women. Treatment continued for a maximum of 14 days (median duration 7 days). When given at a dose of 40 mg once a day subcutaneously, Lovenox significantly reduced the incidence of DVT as compared to placebo. The efficacy data are provided below (see Table 20).

Table 20: Efficacy of Lovenox in the Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility During Acute Illness

At approximately 3 months following enrollment, the incidence of venous thromboembolism remained lower in the Lovenox 40 mg treatment group versus the placebo treatment group.

Treatment Of Deep Vein Thrombosis With Or Without Pulmonary Embolism

In a multicenter, parallel group study, 900 patients with acute lower extremity deep vein thrombosis (DVT) with or without pulmonary embolism (PE) were randomized to an inpatient (hospital) treatment of either (i) Lovenox 1.5 mg/kg once a day subcutaneously, (ii) Lovenox 1 mg/kg every 12 hours subcutaneously, or (iii) heparin intravenous bolus (5000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds). A total of 900 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 60.7 years) with 54.7% men and 45.3% women. All patients also received warfarin sodium (dose adjusted according to PT to achieve an International Normalization Ratio of 2.0 to 3.0), commencing within 72 hours of initiation of Lovenox or standard heparin therapy, and continuing for 90 days. Lovenox or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved. Both Lovenox regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE). The efficacy data are provided below (see Table 21).

Table 21: Efficacy of Lovenox in Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

Similarly, in a multicenter, open-label, parallel group study, patients with acute proximal DVT were randomized to Lovenox or heparin. Patients who could not receive outpatient therapy were excluded from entering the study. Outpatient exclusion criteria included the following: inability to receive outpatient heparin therapy because of associated comorbid conditions or potential for non-compliance and inability to attend follow-up visits as an outpatient because of geographic inaccessibility. Eligible patients could be treated in the hospital, but ONLY Lovenox patients were permitted to go home on therapy (72%). A total of 501 patients were randomized in the study and all patients were treated. Patients ranged in age from 19 to 96 years (mean age 57.8 years) with 60.5% men and 39.5% women. Patients were randomized to either Lovenox 1 mg/kg every 12 hours subcutaneously or heparin intravenous bolus (5000 IU) followed by a continuous infusion administered to achieve an aPTT of 60 to 85 seconds (in-patient treatment). All patients also received warfarin sodium as described in the previous study. Lovenox or standard heparin therapy was administered for a minimum of 5 days. Lovenox was equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism. The efficacy data are provided below (see Table 22).

Table 22: Efficacy of Lovenox in Treatment of Deep Vein Thrombosis

Prophylaxis Of Ischemic Complications In Unstable Angina And Non–Q-Wave Myocardial Infarction

In a multicenter, double-blind, parallel group study, patients who recently experienced unstable angina or non–Q-wave myocardial infarction were randomized to either Lovenox 1 mg/kg every 12 hours subcutaneously or heparin intravenous bolus (5000 U) followed by a continuous infusion (adjusted to achieve an aPTT of 55 to 85 seconds). A total of 3171 patients were enrolled in the study, and 3107 patients were treated. Patients ranged in age from 25 to 94 years (median age 64 years), with 33.4% of patients female and 66.6% male. Race was distributed as follows: 89.8% Caucasian, 4.8% Black, 2.0% Asian, and 3.5% other. All patients were also treated with aspirin 100 to 325 mg per day. Treatment was initiated within 24 hours of the event and continued until clinical stabilization, revascularization procedures, or hospital discharge, with a maximal duration of 8 days of therapy. The combined incidence of the triple endpoint of death, myocardial infarction, or recurrent angina was lower for Lovenox compared with heparin therapy at 14 days after initiation of treatment. The lower incidence of the triple endpoint was sustained up to 30 days after initiation of treatment. These results were observed in an analysis of both all-randomized and all-treated patients. The efficacy data are provided below (see Table 23).

Table 23: Efficacy of Lovenox in the Prophylaxis of Ischemic Complications in Unstable Angina and Non–Q-Wave Myocardial Infarction (combined endpoint of death, myocardial infarction, or recurrent angina)

The combined incidence of death or myocardial infarction at all time points was lower for Lovenox compared to standard heparin therapy, but did not achieve statistical significance. The efficacy data are provided below (see Table 24).

Table 24: Efficacy of Lovenox in the Prophylaxis of Ischemic Complications in Unstable Angina and Non–Q-Wave Myocardial Infarction (Combined endpoint of death or myocardial infarction)

In a survey one year following treatment, with information available for 92% of enrolled patients, the combined incidence of death, myocardial infarction, or recurrent angina remained lower for Lovenox versus heparin (32.0% vs 35.7%).

Urgent revascularization procedures were performed less frequently in the Lovenox group as compared to the heparin group, 6.3% compared to 8.2% at 30 days (p=0.047).

Treatment Of Acute ST-Segment Elevation Myocardial Infarction

In a multicenter, double-blind, double-dummy, parallel-group study, patients with acute ST-segment elevation myocardial infarction (STEMI) who were to be hospitalized within 6 hours of onset and were eligible to receive fibrinolytic therapy were randomized in a 1:1 ratio to receive either Lovenox or unfractionated heparin.

Study medication was initiated between 15 minutes before and 30 minutes after the initiation of fibrinolytic therapy. Unfractionated heparin was administered beginning with an intravenous bolus of 60 U/kg (maximum 4000 U) and followed with an infusion of 12 U/kg per hour (initial maximum 1000 U per hour) that was adjusted to maintain an aPTT of 1.5 to 2 times the control value. The intravenous infusion was to be given for at least 48 hours. The Lovenox dosing strategy was adjusted according to the patient’s age and renal function. For patients younger than 75 years of age, Lovenox was given as a single 30 mg intravenous bolus plus a 1 mg/kg subcutaneous dose followed by a subcutaneous injection of 1 mg/kg every 12 hours. For patients at least 75 years of age, the intravenous bolus was not given and the subcutaneous dose was reduced to 0.75 mg/kg every 12 hours. For patients with severe renal insufficiency (estimated creatinine clearance of less than 30 mL per minute), the dose was to be modified to 1 mg/kg every 24 hours. The subcutaneous injections of Lovenox were given until hospital discharge or for a maximum of eight days (whichever came first). The mean treatment duration for Lovenox was 6.6 days. The mean treatment duration of unfractionated heparin was 54 hours.

When percutaneous coronary intervention was performed during study medication period, patients received antithrombotic support with blinded study drug. For patients on Lovenox, the PCI was to be performed on Lovenox (no switch) using the regimen established in previous studies, i.e. no additional dosing, if the last subcutaneous administration was less than 8 hours before balloon inflation, intravenous bolus of 0.3 mg/kg Lovenox if the last subcutaneous administration was more than 8 hours before balloon inflation.

All patients were treated with aspirin for a minimum of 30 days. Eighty percent of patients received a fibrin-specific agent (19% tenecteplase, 5% reteplase and 55% alteplase) and 20% received streptokinase.

The primary efficacy endpoint was the composite of death from any cause or myocardial re-infarction in the first 30 days after randomization. Total follow-up was one year.

Table 25: Efficacy of Lovenox in the Treatment of Acute ST-Segment Elevation Myocardial Infarction

The beneficial effect of Lovenox on the primary endpoint was consistent across key subgroups including age, gender, infarct location, history of diabetes, history of prior myocardial infarction, fibrinolytic agent administered, and time to treatment with study drug (see Figure 1); however, it is necessary to interpret such subgroup analyses with caution.

Figure 1: Relative Risks of and Absolute Event Rates for the Primary Endpoint at 30 Days in Various Subgroups*

* The primary efficacy endpoint was the composite of death from any cause or myocardial re-infarction in the first 30 days. The overall treatment effect of Lovenox as compared to the unfractionated heparin is shown at the bottom of the figure. For each subgroup, the circle is proportional to the number and represents the point estimate of the treatment effect and the horizontal lines represent the 95% confidence intervals. Fibrin-specific fibrinolytic agents included alteplase, tenecteplase, and reteplase. Time to treatment indicates the time from the onset of symptoms to the administration of study drug (median: 3.2 hours).

The beneficial effect of Lovenox on the primary endpoint observed during the first 30 days was maintained over a 12 month follow-up period (see Figure 2).

Figure 2: Kaplan-Meier Plot – Death or Myocardial Re-infarction at 30 Days – ITT Population

There is a trend in favor of Lovenox during the first 48 hours, but most of the treatment difference is attributed to a step increase in the event rate in the UFH group at 48 hours (seen in Figure 2), an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation. These results provide evidence that UFH was effective and that it would be better if used longer than 48 hours. There is a similar increase in endpoint event rate when Lovenox was discontinued, suggesting that it too was discontinued too soon in this study.

The rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in hematocrit or clinically overt bleeding, including intracranial hemorrhage) at 30 days were 2.1% in the Lovenox group and 1.4% in the unfractionated heparin group. The rates of intracranial hemorrhage at 30 days were 0.8% in the Lovenox group and 0.7% in the unfractionated heparin group. The 30-day rate of the composite endpoint of death, myocardial re-infarction or ICH (a measure of net clinical benefit) was significantly lower in the Lovenox group (10.1%) as compared to the heparin group (12.2%).

Drug Interactions between Coumadin and Lovenox

Moderate

warfarin food

Applies to: Coumadin (warfarin)

Nutrition and diet can affect your treatment with warfarin. Therefore, it is important to keep your vitamin supplement and food intake steady throughout treatment. For example, increasing vitamin K levels in the body can promote clotting and reduce the effectiveness of warfarin. While there is no need to avoid products that contain vitamin K, you should maintain a consistent level of consumption of these products. Foods rich in vitamin K include beef liver, broccoli, Brussels sprouts, cabbage, collard greens, endive, kale, lettuce, mustard greens, parsley, soy beans, spinach, Swiss chard, turnip greens, watercress, and other green leafy vegetables. Moderate to high levels of vitamin K are also found in other foods such as asparagus, avocados, dill pickles, green peas, green tea, canola oil, margarine, mayonnaise, olive oil, and soybean oil. However, even foods that do not contain much vitamin K may occasionally affect the action of warfarin. There have been reports of patients who experienced bleeding complications and increased INR or bleeding times after consuming large quantities of cranberry juice, mangos, grapefruit, grapefruit juice, grapefruit seed extract, or pomegranate juice. Again, you do not need to avoid these foods completely, but it may be preferable to limit their consumption, or at least maintain the same level of use while you are receiving warfarin. Talk to a healthcare provider if you are uncertain about what foods or medications you take that may interact with warfarin. It is important to tell your doctor about all medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
When warfarin is given with enteral (tube) feedings, you may interrupt the feeding for one hour before and one hour after the warfarin dose to minimize potential for interaction. Feeding formulas containing soy protein should be avoided.

Switch to professional interaction data

Coumadin and Lovenox

Date November 7, 2013 Author By Eric Christianson Category Anticoagulation, Coumadin

I could continue on Coumadin for quite a while longer with other cases and stories, but there is too much other cool stuff to cover. I’m going to finish up on “bridging” of anticoagulants. I wrote a little bit the other night about the unique pharmacokinetics (what the body does to the drug) of Coumadin. It does have a relatively long half-life, and takes a while to get to therapeutic dosing. Often an anticoagulant like Lovenox (enoxaparin) will be utilized for individuals at high risk of clotting in the short term setting. Many times patients will be transitioned (or bridged) to Coumadin from Lovenox. Basically what this means is a patient may be on both drugs for a few days because it takes Coumadin a significant amount of time for it to begin its clot preventing effects. A sample order may be “continue Lovenox until INR is greater than or equal to 2”. This practice can be utilized for some of the other newer anticoagulants as well when switching to Coumadin. I’ve definietly seen medication errors where a patient unintentionally received both because the Lovenox was not discontinue as ordered. I’ve got a blast from the past coming for next week! Many of you who have been with me since the start of this know what the most wonderful week of the year is! It’s coming back!!!!

Tags: Coumadin, Lovenox

Bridging Anticoagulation

There are many patients who are receiving long-term treatment with the blood thinner warfarin, whether because of atrial fibrillation (the commonest reason for taking warfarin) or a mechanical heart valve. Such patients frequently require warfarin to be stopped because of an upcoming surgery/procedure. There is uncertainty whether such patients should receive bridging anticoagulation before and after the surgery/ procedure.

The objectives of this article are to (1) clarify what is meant by bridging anticoagulation and for whom it should be considered and (2) to inform readers about the BRIDGE study (Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery), which aims to determine whether bridging anticoagulation is needed during warfarin interruption.

What Is Bridging Anticoagulation?

Bridging anticoagulation refers to giving a short-acting blood thinner, usually low-molecular-weight heparin given by subcutaneous injection for 10 to 12 days around the time of the surgery/procedure, when warfarin is interrupted and its anticoagulant effect is outside a therapeutic range. Bridging anticoagulation aims to reduce patients’ risk for developing blood clots, such as stroke, but may also increase patients’ risk for developing potentially serious bleeding complications after surgery.

How Is Bridging Anticoagulation Given?

After warfarin is stopped, 5 to 6 days before surgery (to allow sufficient time for its anticoagulant effect to wane), bridging anticoagulation is started 3 days before surgery, with the last dose given 24 hours before surgery. After surgery, bridging is resumed no earlier than 24 hours after surgery; at the same time, warfarin is restarted. Bridging is continued, typically for 4 to 6 days, until the anticoagulant effect of warfarin has resumed and the blood is sufficiently thinned again.

What Low-Molecular-Weight Heparin and What Dose Should Be Used for Bridging?

There is no standardized bridging drug or dose. A therapeutic-dose regimen, for example, enoxaparin (Lovenox) 1 mg/kg twice daily, is often used in North America, although some physicians in other countries use lower doses.

What Happens for Patients Who Are Having a Minor Procedure, Such as a Tooth Extraction or Skin Cancer Removal?

For patients having minor dental work, such as a tooth extraction or root canal, it may not be necessary to stop warfarin. Some dentists allow patients to continue warfarin (especially if there are concerns about stopping it), so long as they take a special mouthwash called tranexamic acid (Amicar) just before and 3 times daily for 1 to 2 days after the dental procedure, to help prevent bleeding. For patients having minor skin procedures or cataract surgery, interruption of warfarin is often not required because there is minimal bleeding.

What Happens for Patients Who Are Having a More Extensive Surgery/Procedure in Which the Bleeding Risk Is High?

In such patients (eg, those having hip or knee replacement or cancer surgery), bridging anticoagulation should be given carefully, especially after surgery. Some physicians may choose to delay the resumption of therapeutic-dose low-molecular-weight heparin bridging for 2 to 3 days after surgery, and others may substitute a lower dose of low-molecular-weight heparin after surgery. There is no single approach, but the intent is to prevent bleeding, typically at the surgical/procedure site. If bleeding occurs, it will further delay the resumption of anticoagulation and will expose patients to an increased risk for blood clots. In other words, if bleeding occurs (perhaps because low-molecular-weight heparin bridging was given too close to surgery), this will have the opposite effect of what bridging was meant to do and can harm patients.

Who Should Receive Bridging Anticoagulation?

This is an unanswered question, because there are no completed high-quality clinical studies (referred to as randomized, controlled trials) that tell us who should be bridged. In the meantime, clinical experts have suggested a risk classification scheme to help identify which patients may or may not need bridging (Table), but much work needs to be done. The BRIDGE study will help to address this large gap in our knowledge.

Table. Risk Stratification for Perioperative Arterial and Venous Thromboembolism to Guide Whether Bridging Anticoagulation Is Needed

Thromboembolic Risk Category Clinical Indication for Warfarin Therapy
Atrial Fibrillation Mechanical Heart Valve Venous Thromboembolism
High risk (annual risk >10%) CHADS2 score 5 or 6 Any mechanical mitral valve Recent (within 3 mo) VTE
Recent (within 3 mo) stroke/TIA Older aortic mechanical valve (caged-ball, tilting disk) High-risk thrombophilia‡
Rheumatic valvular heart disease Recent (within 3 mo) stroke or TIA
Moderate risk (annual risk 5% to 10%) CHADS2 score 3 or 4 Bileaflet aortic valve prosthesis with ≥1 risk factor† VTE within 3–12 mo
Moderate-risk thrombophilia§
Recurrent VTE
Active cancer‖
Low risk (annual risk <5%) CHADS2 score 0–2 (no prior stroke or TIA) Bileaflet aortic bileaflet without any risk factors† VTE >12 mo ago

CHADS2 indicates score based on cardiac failure-hypertension-age-diabetes-stroke; VTE, venous thromboembolism; and TIA, transient ischemic attack.

*Additional patients who may be at high risk include those with prior thromboembolism during interruption of warfarin.

†Age ≥75 years, atrial fibrillation, congestive heart failure, hypertension, diabetes mellitus, or stroke or TIA.

‡Deficiency of protein C, protein S, or antithrombin; antiphospholipid syndrome; homozygous factor V Leiden or prothrombin gene mutation.

§Heterozygous factor V Leiden or prothrombin gene mutation.

‖Cancer that is metastatic or treated within the past 6 months.

What Is the BRIDGE Study?

The BRIDGE study is a National Institutes of Health–sponsored randomized trial (registered at http://www.clinicaltrials.gov, unique identifier NCT00786474) that aims to determine whether bridging anticoagulation is needed in patients with atrial fibrillation who are receiving warfarin and need to undergo a surgery/procedure. Eligible patients are randomly allocated to receive bridging anticoagulation (dalteparin 100 IU/kg twice daily) or matching placebo when warfarin is interrupted. BRIDGE will study >3600 patients in >90 clinical centers in the United States, Canada, and Brazil. A more detailed description of the study is available at the BRIDGE public Web site (https://bridge.dcri.duke.edu/).

Why Is the BRIDGE Study Needed?

In simple terms, we do not know whether bridging anticoagulation helps patients. On the one hand, some physicians think it may reduce patients’ risk for developing stroke and other blood clots. On the other hand, others think it is not helpful and may cause harm by increasing the risk for bleeding complications. When such uncertainty exists about whether a treatment works, a randomized trial is justified to determine best practices and is ethical. Studies such as BRIDGE are also important because of the many patients (millions worldwide) for whom the results are applicable.

Who Is Eligible to Participate in the BRIDGE Study?

Warfarin-treated patients with atrial fibrillation or flutter (nonvalvular or valvular) with ≥1 additional risk factor for stroke (age ≥75 years, hypertension, diabetes mellitus, congestive heart failure, prior stroke or transient ischemic attack) and who require an elective (nonemergency) surgery/procedure are eligible.

Will a Placebo-Controlled Trial (or Bridging or No Bridging) Be Acceptable to Patients and Their Physicians?

Any placebo-controlled trial should be considered carefully. The BRIDGE investigators believe such a trial is acceptable for 3 reasons: (1) The efficacy and safety of bridging anticoagulation are not established; we simply do not know whether bridging works. (2) There is no established standard of care. This means that among patients who require warfarin interruption, a no-bridging approach is as acceptable as bridging. (3) Clinical practice guidelines provide weak (or uncertain) recommendations about whether to bridge, because sufficient evidence from well-designed trials is lacking.

How Can I (as a Patient or a Physician) Help the BRIDGE Study to Answer the Question of Whether “Bridging Anticoagulation” Is Needed?

Sources of Funding

This work did not receive any funding support. The BRIDGE Trial is funded by the National Institutes of Health’s National Heart, Lung, and Blood Institute.

Disclosures

None.

Footnotes

Correspondence to Dr James D. Douketis, St. Joseph’s Healthcare Hamilton, Room F-544, 50 Charlton Ave E, Hamilton, Ontario, Canada, L8N 4A6. E-mail ca

Further Reading

  • Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based and practical approach. Blood. 2011; 117:5044–5049.CrossrefMedlineGoogle Scholar
  • Spyropoulos AC. Bridging therapy and oral anticoagulation: current and future prospects. Curr Opin Hematol. 2010; 17:444–449.CrossrefMedlineGoogle Scholar

Monitoring for long term LMWH therapy

  • Monitoring Antithrombotic Therapy
    • Summary of tests
    • Anti-Xa activity for heparin
    • Anti-Xa activity for LMWH
    • Apixaban
    • Chromogenic factor Xa
    • Dabigatran assay
    • Direct oral anticoagulant screen
    • Direct thrombin inhibitor assay
    • Fondaparinux assay
    • INR by Point-of-Care Testing
    • Rivaroxaban assay
  • Anticoaguation and neuraxial anesthesia
    • Neuraxial guidelines
  • Bleeding Risk Assessment
    • Bleeding risk assessment
  • Central venous catheter management
  • Chronic antithrombotic therapy
    • Recommendations for chronic antithrombotic therapy
  • Guidelines for reversal of anticoagulation
    • Anticoagulant reversal for IPH
      • Guidelines for Reversing Coagulopathies in Patients with Symptomatic Spontaneous IPH
      • Spontaneous IPH: Reversal Guide for DOACs
      • Spontaneous IPH: Reversal Guide for Warfarin
    • Guidelines for Reversal of Anticoagulants
    • Head injury in anticoagulated patients
    • UW – CT Surgery Perioperative Hemostasis Plan
  • Heparin-induced thrombocytopenia (HIT)
    • Guidelines for Management of HIT
    • Pre-test probability scoring for HIT
    • Guidelines for the use of bivalirudin in HIT
    • Guidelines for the use of argatroban in HIT
    • Monitoring direct thrombin inhibitors with the UW DTI assay
  • Mechanical Circulatory Support
    • MCS – Anticoagulation Guidelines
    • UW Medicine MCS Program
  • Peri-procedural anticoagulation
    • Anticoagulation around invasive procedures
      • Risk Stratification and Recommendations for Bridge Therapy
      • Stroke risk assessment in patients with atrial fibrillation (CHADS2/CHADS2Vasc)
      • Suggestions for anticoagulation management
      • Patient instruction forms for bridge therapy
    • Anticoagulation around dental procedures
      • Suggestions for anticoagulation management before and after dental procedures
      • Local methods to prevent or control bleeding
      • Aminocaproic Acid (ACA) 5% mouth rinse
    • Management of Antithrombotic Therapy for Chronic Pain Procedures
    • Management of Antithrombotic Therapy for Neuraxial Procedures
    • Perioperative Management of Antiplatelet Therapy
  • VTE
    • VTE prophylaxis
      • Guidelines for prevention of VTE in hospitalized patients. Part 1: Risk Assessment and General Recommendations
      • Guidelines for prevention of VTE in hospitalized patients. Part 2: Recommendations by Clinical Group
    • DVT
      • DVT diagnostic algorithm
    • PE
      • UWMC Pulmonary Embolism Response Team (PERT)
      • HMC Pulmonary Embolism Response Team (PERT)
    • VTE Treatment
      • VTE treatment algorithm
      • Duration of treatment for VTE
      • Guidelines for management of cancer-associated thrombosis
      • Management of Superficial Vein Thrombosis
      • Outpatient Treatment of DVT and Low Risk PE

What are anticoagulants and why are they used in lupus treatment?

Warfarin (Coumadin) and heparin are anticoagulants (“blood thinners”), medications that decrease the ability of the blood to clot. About one-third of people with lupus have antibodies to molecules in the body called phospholipids. Sometimes these antiphospholipid antibodies (called anticardiolipin, lupus anticoagulant, or anti-beta2glycoprotein I) can lead to blood clots—thromboses—such as deep venous thrombosis, stroke, or heart attack.

A blood clot by itself is called a thrombus; a blood clot that breaks off and travels elsewhere in your circulatory (blood) system is called an embolus. It is rare for a blood clot to migrate to another part of the body and block one of your blood vessels, but if it does (a condition doctors call a thromboembolism), it is always serious. Blood clots can cut off circulation to your arms, legs, lungs (pulmonary embolism), brain (stroke), and heart (heart attack).

How do anticoagulants work?

Warfarin and heparin work in slightly different ways, but both block the production of certain proteins in your liver that work together to help your blood to clot. These proteins are called “cofactors.” Vitamin K controls the creation of these cofactors in your liver, and warfarin reduces clotting in your blood by preventing vitamin K from working correctly. Heparin also works by preventing certain cofactors, namely thrombin and fibrin, from working correctly. By blocking the process early on, both warfarin and heparin ultimately help to reduce blood clots from forming in your body.

How should I take these medications?

Warfarin comes in tablet form, and heparin must be given as an injection. The amount of medication needed differs with each person and each situation, and individuals on these medications should be closely monitored by their doctors to ensure that they are being given the correct dose.

Can I take these medications while I am pregnant?

Warfarin (Coumadin) is not safe during pregnancy. It can cause birth defects and fetal bleeding. Women who take warfarin must switch to heparin or low molecular weight heparin before they become pregnant, since heparin or low molecular weight heparin (Lovenox, Fragmin) do not cross the placenta into the fetus.

What should I remember while taking anticoagulants?

Do not smoke or drink alcohol while taking anticoagulants. Smoking increases the risk of blood clots and cardiovascular disease, and cardiovascular disease is the number one cause of death in people with lupus. Alcohol can interfere with the effectiveness of anticoagulant medications, can be harmful to your liver, and can irritate your stomach (gastritis), causing bleeding.

Warfarin

Warfarin is the most widely used anticoagulant, but because everyone differs in their physiological make-up, dosage requirements differ from person to person. Blood clotting is a natural protective mechanism employed by the body to seal off damaged blood vessels; any medication that alters this natural protective mechanism must be carefully monitored. People taking warfarin must obtain a blood test every 2-4 weeks to ensure that their blood is thinning to the correct degree without bleeding complications. This test (the INR, discussed below) may be requested several times a week at the beginning of your treatment to ensure that you are started on the correct dose.

The two tests used to monitor warfarin levels in the blood are the Prothrombin Time (or, just “Pro-Time,” or “PT”) and a test called an INR (International Normalized Ratio). In actuality, Prothrombin time is the test used, and INR is simply a standardized way for medical institutions to report consistent values for Prothrombin times. The INR ratio is calculated based on comparison of blood tests against a known standard, and your physician will monitor your warfarin levels based on this INR ratio. Generally, an INR of 2.5 to 3.0 indicates that the patient is receiving the correct dose of warfarin; INR values above 5.0 can be dangerous, and those below 1.0 indicate no warfarin effect.

Heparin

Heparin works faster than warfarin, so it is usually given in situations where an immediate effect is desired. For example, this medication is often given in hospitals to prevent growth of a previously detected blood clot. This medication is also recommended for pregnant women in whom antiphospholipid antibodies have been discovered, since warfarin can be harmful to an unborn child. However, when taken for long periods of time, this medication might increase the risk of osteoporosis. Usually patients switch to warfarin when long term anticoagulant treatment is recommended.

What are the potential side effects of anticoagulants?

The two most serious side effects of anticoagulants are bleeding and gangrene (necrosis) of the skin. Bleeding can occur in any organ or tissue. Bleeding in the kidneys can cause severe back pain and blood in the urine. Bleeding in the stomach can cause weakness, fainting, black stools, or vomiting of blood. Bleeding of the brain can cause severe headache and paralysis, and bleeding of the joints can cause joint pain and swelling.

Other side effects can include rash, bloating, diarrhea, jaundice (yellowing of the eyes and skin), hair loss, itchy feet, pain in the toes, and, in the case of heparin, mild pain, redness, or warmth at the injection site. Bleeding gums, excessive bruising, nosebleeds, heavy menstrual bleeding, and prolonged bleeding from cuts may indicate an overdosing of medication. Notify your doctor if these problems occur.

Some people receiving heparin have experienced a reaction to the infusion, so contact your doctor immediately if you experience any abrupt and serious side effects, such as sudden numbness, confusion, swelling, or trouble breathing.

What medications and foods should I avoid while taking anticoagulants?

While taking anticoagulants, you should avoid supplements with vitamin K. Remember that vitamin K controls the formation of proteins in your liver involved in clotting, so taking in vitamin K can work to counteract your medication and increase your risk of blood clots. In addition, you should avoid medications that can increase your risk of bleeding. These medications include aspirin, NSAIDs, multivitamins with vitamin K, and fish oil. Any antibiotic may change the Coumadin INR test. If you must take an antibiotic, notify your Coumadin clinic so that they may schedule an additional INR check. In addition, be sure to speak with your doctor before starting any new medications. Your physician may also recommend that you carry some sort of identification to alert health professionals of your use of anticoagulants should an emergency or other situation arise.

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