- 21 Things Cipro’s Warning Label WON’T Tell You
- How Do Antibiotics Work?
- The History of Cipro
- Who Should Avoid Taking Cipro?
- Cipro Side Effects
- Benefits vs. Permanent Side Effects
- Cipro and Aortic Bulges and Tears
- Cipro Lawsuits
- We Are Not Accepting Cipro Injury Monetary Compensation Cases
- Can Levofloxacin Cause Muscle and Joint Pain?
21 Things Cipro’s Warning Label WON’T Tell You
we´ve received the following story of a Cipro victim:
1. The side effects listed on Cipro’s warning label (plus many others that aren’t) can be PERMANENT and result in lifelong disability!!! 95% of prescription drugs on the market today have transient side effects, meaning their side effects cease once the drug is stopped. This is NOT the case with Cipro! Often times Cipro’s most devastating side effects don’t even surface until after you’ve completed your entire course, and they then persist for months, years or in some cases forever! Bayer blatantly hides this fact, as the word “permanent” appears absolutely NOWHERE on Cipro’s warning label!!! This is criminal.
2. Cipro is a purely synthetic chemotherapeutic antibiotic in the fluoroquinolone (also called “quinolone” or just “quin”) class of drugs. Over HALF of all fluoroquinolone antibiotics have been pulled from the market for their horrific safety records. And the ones that remain on the market (Cipro, Levaquin, Avelox and a few others) are no safer! A study of ADRs in Italy, published in 2005, found that among more than 50 types of drugs, fluoroquinolones were involved in the largest number of serious problems and accounted for 11 percent of all adverse events.1 Every single drug in this class carries a black box warning–the equivalent of a skull & crossbones–for its nasty side effects. A black box warning is the last step before taking a drug completely off the market. There is NO SUCH THING as a safe fluoroquinolone antibiotic!
3. The risk of experiencing an adverse reaction to Cipro (including, but certainly not limited to tendon rupture) is MUCH higher than the warning label would have you believe. These adverse reactions are also much more severe and long-lasting than Bayer will admit to.
4. Cipro’s warning label makes it sound as if tendon rupture is the worst possible scenario. What it doesn’t tell you is that Ciprofloxacin actually unleashes an entire systemic toxicity SYNDROME often referred to by victims as “floxing” or being “floxed.” Others refer to it as “fluoroquinolone toxicity syndrome.” Regardless of what you want to call it, it is absolutely devastating and commonly includes 30-40 different adverse symptoms all being experienced simultaneously and lasting for YEARS. Many of these symptoms are devastating in and of themselves. This Cipro-induced toxicity syndrome wreaks absolute havoc on EVERY part of a person’s body–every tendon and joint in the body can become affected, every organ (including the brain), peripheral nervous system (resulting in severe and potentially permanent pain conditions, muscle weakness or automonic dysfunction), vision damage up to and including temporary blindness, retinal tears and/or permenant double vision, permanent tinnitus (ringing in the ears), long lasting or permanent central nervous system damage (including unrelenting insomnia, memory problems, random panic, depersonalization, psychosis), chronic fatigue, multiple chemical sensitivities, severe muscle wasting, hair loss, skin changes, severe dryness issues (dry skin/eyes/mouth/nose), extensive dental damage and on and on and ON. While many of these side effects are indeed listed on Cipro’s warning label, many are not. And again, nowhere in the drug’s literature does Bayer acknowlege the existence of this devastating syndrome–nor do they disclose that if you fall victim to it you’ll be experiencing nearly ALL of the ADR’s listed on the warning label at once!!! More than a few victims, as you may imagine, have been driven to suicide as a result of being floxed by fluoroquinolone antibiotics including Cipro.
5. Cipro attacks much more than just your tendons–it is toxic to ALL connective tissues including muscle/bone/fascia/skin/nerves/even cartilage!!!2 A labratory study done on puppies showed that Cipro actually melts the cartilage out of their joints! (In case you didn’t already know–cartilage does not regenerate! Once it’s gone, it’s gone. Hip/knee replacements, anyone?). Degeneration of the cartilage matrix in humans has been observed following as few as two oral doses of ciprofloxacin.3 This information has been known by scientists for over a DECADE now, and yet the word “cartilage” still appears absolutely nowhere on Cipro’s warning label! Wouldn’t you like to know before you ingest a drug that it could potentially destroy your cartilage?!
6. Cipro does not cause “tendonitis” as Bayer describes it on the warning label. Tendonitis is an overuse injury. Ciprofloxacin is directly toxic to tendon cells, chemically altering and destroying them on a cellular or even DNA level. There’s a big difference!
7. Cipro-induced injuries DO NOT HEAL NORMALLY, if at all. Floxed bodies lose their ability to heal! A small injury that would heal in a matter of days for a “normal” person often takes weeks or months to heal in a floxed person, or may even become permenant.
8. Cipro can and will attack your body regardless of your age or prior level of health. Do not think that because you are young, healthy or have never experienced any tendon or joint problems that you are safe taking this drug. It doesn’t work that way! In fact Cipro is not even permitted for use in patients under the age of 18. Why? Because it interferes with the development of childrens’ still-growing connective tissues. There’s that “connective tissues” thing again…are you starting to see a pattern with this stuff? Cipro can render a top athlete of any age completely crippled and unable to walk, let alone workout or compete ever again.
9. Do not think because you’ve taken Cipro on previous occassions without any apparent problems that you’re safe to take it again! Cipro damage is cumulative, and the drug can turn on you at any time. Everyone’s threshold is different, but given enough of it, anyone can and will become floxed by Cipro. Once you surpass your threshold–that’s it. There is no going back. Many disabled Cipro victims report having taken Cipro “successfully” a number of times before it finally turned on them.
10. Unlike most other drugs whose side effects surface while actually on the medication, Cipro is capable of causing severe delayed reactions that don’t even manifest until long after you’ve finished taking the drug. This is unbelievably dangerous. What it means is that you could be having a potentially permanent, crippling reaction to the drug and have NO IDEA until it’s too late! Victims often report finishing some or all of their pills before the “bomb” finally goes off inside their body. It is not uncommon for a week or two to pass between the completion of a course of Cipro and the onset of its toxicity. Once you become floxed, your risk of spontaneously tearing or rupturing a tendon continues for up to FIVE YEARS after you have ingested the medication!!! Obviously people who suffer delayed reactions often never make the connection between their sudden ‘mysterious’ health problems and the antibiotic they took days, weeks or even months prior, so these reactions go largely unreported.
11. Numerous individuals (both young and old) have had to undergo full joint replacement surgeries after taking Cipro! And yet joint destruction appears NOWHERE on the warning label.
12. People have wound up on crutches or in wheelchairs for the rest of their lives from as little as a few pills. As stated earlier, it is not uncommon for every tendon and joint in a person’s body to become affected including shoulders, arms and hands, so there are instances where an electric wheelchair or motorized scooter becomes one’s only option. You know you’re disabled when you can’t even wheel yourself around in a standard wheelchair!
13. In addition to being highly toxic to connective tissue, Cipro is also a neurotoxin capable of crossing the blood-brain barrier and causing severe long-term neuropsychiatric side effects. These include panic and anxiety, insomnia, seizures, confusion, depersonalization, psychosis, dystonia, memory loss, paranoia and hallucinations. These side effects can persist for YEARS or in some instances even be permenant! People have ended up in psychiatric wards or worse–killed themselves–as a result of some of these psychiatric side effects. Imagine for a moment being unable to sleep more than 1-2 hours a night, every night, for YEARS!!! video
14. There are entire online forum communities and support groups full of fluoroquinolone antibiotic (Cipro) victims.
15. Dental damage! Cipro can calcify all of the nerves in your teeth as well as permanently dry out your mouth, promoting extensive tooth decay and/or tooth loss. There are people in their thirties who now wear dentures as a direct result of Cipro destroying all of their teeth from the inside out! Others have had teeth literally break off at the gum line after becoming floxed. Again–NO mention of this anywhere on the warning label!
16. As stated previously, Cipro is a 100% synthetic chemotherapeutic drug. It works by interfering with bacterial DNA, preventing it from replicating. The problem is, how can a synthetic chemical differentiate between bacterial DNA and your DNA!? As it turns out, it can’t. Hint: If your cells can not replicate, your body literally begins to fall apart! Which…ironically…is exactly what happens when a person becomes floxed! Tendons literally just fall off the bone, retinas spontaneously tear, cartilage erodes out of joints.
17. The vast majority of doctors are completely ignorant about Cipro and its horrific and long-lasting side effects. Most won’t believe you when you tell them a prescription antibiotic has caused your slew of sudden disabling health problems–even if your symptoms match the ones listed right on the drug’s warning label! They’ll insist that the drug can’t possibly still be harming you days/weeks/months/years after you’ve ingested it. They’ll try and tell you you’re just getting old or they’ll subject you to a myriad of expensive testing in hopes of finding an auto-immune disorder or some other explanation for your problems. Only there is no auto-immune disorder you were poisoned by Cipro. Even if you do manage to find a doctor who is familiar with Cipro toxicity, there is absolutely nothing they or anyone else can do to reverse the damage once it has occurred. There is quite simply NO treatment for floxing–no remedy, no tonic, no antidote. Once the damage is done, it’s DONE. And yet Cipro’s warning label instructs you to call your doctor immediately if you begin showing signs of an adverse reaction! What’s the point?!
18. Doctors often try to misdiagnose flox victims as having auto-immune disorders such as multiple sclerosis, since many Cipro-induced health problems mimic those of auto-immune disorders. Other favorite misdiagnosises include reflex sympathetic dystrophy (also called chronic regional pain syndrome or CRPS), fibromyalgia, chronic fatigue syndrome, Raynaulds syndrome, and Sjogrens. Very few doctors–outside of alternative practitioners–will ever attribute your slew of health problems to having been poisoned by a prescription drug.
19. Bayer does not know the mechanism behind how or why Cipro cripples people (at least that’s what they claim). They also do not care, and are not interested in finding out. Bayer does NOT like to hear from their victims and does everything in their power to silence them. Many websites set up in order to spread information and awareness about floxing have been threatened with legal action and shut down. Others have ‘mysteriously’ disappeared from the web over the years without explanation. We’ll see how long this one lasts!
20. If you become crippled by Cipro, don’t expect any lawyers to take your case. They will claim you were warned. Of course, as I have just outlined, you were not at all warned adequately or truthfully about the scope, liklihood, severity or duration (aka permanence) of Cipro’s nasty and life-altering side effects. Then there’s the issue of proving cause and effect and statute of limitations with a drug whose side effects sometimes don’t surface until years after being ingested! Talk about the perfect crime!
21. SSDI does not recognize Cipro poisoning as a diagnosis, so you will have to fight tooth and nail to obtain any disability benefits once you’ve become crippled. The very government that allows this poison to be handed out like candy then turns around and tries to prevent you from collecting disability benefits once you’ve fallen victim to it!
In short, a prescription for Cipro could end up being the most expensive prescription you EVER fill. My life ended on October 25th 2009 thanks to just (12) 500mg Cipro pills I’d taken over the course of six days. Other than a suspected urinary infection, I had been an incredibly healthy and active 30-year-old prior to ingesting those six grams worth of poison. SIX GRAMS was all it took to completely and utterly end my life. I met NONE of the “risk factors” listed on Cipro’s warning label, and yet here I am years later essentially bedridden and unable to walk with devastating injuries to my musculoskeletal and nervous systems. Think for a moment of all the things that make your life worth living. Now imagine suddenly being unable to do any of those things. That is my reality now thanks to Bayer Pharmaceuticals, an inept FDA and my doctor who I trusted to “do no harm.” Those 12 pills cost me absolutely EVERYTHING. No more work. No more traveling. No more gym. No more living on my own. No more walks around the neighborhood. No more trips to the mall. No more grocery shopping. No more swimming. No more tennis. No more bowling. No more dating. No more dreams of buying my own home or opening my own business. Hell, I can’t even walk to the mailbox! My car is gone, credit is destroyed, quality of life demolished. EVERYTHING IS GONE NOW!!!
This site is my way of screaming from the mountaintops since the FDA is obviously NOT doing their job!!! Bayer may have crippled me but as long as I’m still breathing they will NEVER shut me up about this! I will do my best to spread this website to the far reaches of the internet in an effort to try and reach as many people as possible before they too become unsuspecting victims of this horrific drug. This NEVER should have happened to me–not when there are a plethora of other, safer antibiotics on the market that are just as effective at killing bacteria WITHOUT the risk of permanently maiming you! The fact that both Bayer and the FDA know about Cipro’s horrific safety profile and not only look the other way but actively COVER UP these facts and keep them hidden from the public and the medical community is downright criminal!!! Do you know that I’ve filed adverse reaction reports with the FDA every six months since this happened to me and not ONCE has anyone from the FDA bothered to contact me for any further information? As it turns out, the FDA’s main interest is NOT assuring public safety but rather maximizing drug company profits.
Please read my story, visit the external links I have compiled and warn everyone you know about what is happening. I do not want one more person to fall victim to Bayer’s limitless greed and the FDA’s utter ineptitude and corruption!
CIPRO IS POISON!!!
Before you start taking Cipro, tell your doctor about any allergies, medical conditions, and medicines you take. Include over-the-counter medicines or herbal supplements, particularly antacids. Tell your doctor if you are pregnant, breast-feeding, or planning to become pregnant.
While taking Cipro, use caution when driving or using machinery until you know whether it makes you dizzy, confused, or tired. Also, take care to protect yourself from the sun. Cipro can make your skin more sensitive.
If you start feeling pain, swelling, or stiffness, or have trouble with muscle movement, stop taking Cipro and get emergency help. Tendinitis is a potential risk of taking Cipro. It is caused when tissue that connects bone to muscle in your body swells. In some cases, taking Cipro might cause a tendon to rupture. Tendinitis can happen while you are taking Cipro or months later. While tendonitis can happen to anyone taking Cipro, it most often happens in people over age 60, those taking corticosteroids, or those who have had a kidney, heart, or lung transplant.
You may experience side effects while taking Cipro, such as headaches, vaginal itching or discharge, an urgent need to urinate, or gastrointestinal symptoms such as nausea and heartburn. Call your doctor if these effects are severe or do not go away.
Finish your entire Cipro prescription, unless you experience tendonitis, tendon rupture, or an allergic reaction. If you do not finish treatment, the bacteria may become resistant to Cipro. Unless the following side effects of Cipro are severe or become bothersome, they don’t usually need medical attention:
- Nausea or upset stomach
- White patches or sores in the mouth
Get immediate medical help if you are taking Cipro and have any of the following side effects:
- Severe diarrhea or stomach cramps, up to two months after you stop taking Cipro
- Skin problems such as rash, blisters, hives, or itching
- Swelling of areas on your head, neck, or extremities
- Hoarseness, wheezing, or difficulty breathing or swallowing
- Changes in heart rate
- Joint or muscle pain
- Unusual bruising or bleeding
- Extreme tiredness, lack of energy, or loss of appetite
- Pain in the upper right part of the stomach
- Yellowing of the skin or eyes
- Dark-colored urine
- Flu-like symptoms
- Seizures, dizziness, confusion, restlessness, or anxiety
- Sleep problems or nightmares
- Paranoia, hallucinations, or suicidal thoughts
- Uncontrollable shaking or pain, burning, tingling, or numbness
How Do Antibiotics Work?
Antibiotics are powerful medications that work very well for certain types of illnesses. However, some antibiotics are now less useful than they once were due to an increase in antibiotic resistance.
Antibiotic resistance occurs when bacteria can no longer be controlled or killed by certain antibiotics. In some cases, this can mean there are no effective treatments for certain conditions.
Each year, 2 million people are infected with bacteria that are resistant to antibiotics, resulting in at least 23,000 deaths.
When you take an antibiotic, the sensitive bacteria are eliminated. The bacteria that survive during antibiotic treatment are often resistant to that antibiotic. These bacteria often have unique characteristics that prevent antibiotics from working on them.
Some serious antibiotic-resistant infections include:
Clostridium difficile (C. diff)
The overgrowth of this type of bacteria causes infection in both your small and large intestines. This often occurs after someone’s treated with antibiotics for a different bacterial infection. C. diff is naturally resistant to many antibiotics.
Vancomycin-resistant enterococcus (VRE)
These bacteria often infect your bloodstream, urinary tract, or surgical wounds. This infection typically occurs in people who are hospitalized. Enterococci infections may be treated with the antibiotic vancomycin, but VRE is resistant to this treatment.
Methicillin-resistant Staphylococcus aureus (MRSA)
This type of infection is resistant to traditional staph infection antibiotics. MRSA infections typically occur on your skin. It’s most common in people in hospitals and those with weakened immune systems.
Carbapenem-resistant Enterobacteriaceae (CRE)
This class of bacteria are resistant to a lot of other antibiotics. CRE infections typically occur in people in hospitals and who are on a mechanical ventilator or have indwelling catheters.
The most important cause of antibiotic resistance is inappropriate use or overuse of antibiotics. As much as 30 percent of antibiotic use is thought to be unnecessary. This is because antibiotics are often prescribed when they aren’t needed.
Several important steps can be taken to decrease inappropriate antibiotic use:
- Take antibiotics only for bacterial infections. Don’t use antibiotics for conditions caused by viruses such as the common cold, flu, cough, or sore throat.
- Take antibiotics as directed by your healthcare provider. Using the wrong dose, skipping doses, or taking it longer or shorter than directed might contribute to bacteria resistance. Even if you feel better after a few days, talk with your healthcare provider before discontinuing an antibiotic.
- Take the right antibiotic. Using the wrong antibiotic for an infection might lead to resistance. Don’t take antibiotics prescribed for someone else. Also, don’t take antibiotics left over from a previous treatment. Your healthcare provider will be able to select the most appropriate antibiotic for your specific type of infection.
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Disabling and Potentially Irreversible Serious Adverse Reactions
- Tenditits and Tendon Rupture
- Peripheral Neuropathy
- Central Nervous System Effects
- Exacerbation of Myasthenia Gravis
- Other Serious and Sometimes Fatal Adverse Reactions
- Hypersensitivity Reactions
- Serious Adverse Reactions with Concomitant Theophylline
- Clostridium difficile-Associated Diarrhea
- Prolongation of the QT Interval
- Musculoskeletal Disorders in Pediatric Patients
- Development of Drug Resistant Bacteria
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 practice.
Clinical trials in patients with urinary tract infections enrolled 961 patients treated with 500 mg or 1000 mg CIPRO XR. The overall incidence, type and distribution of adverse reactions were similar in patients receiving both 500 mg and 1000 mg of CIPRO XR. The adverse reaction information from clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
In the clinical trial of uncomplicated UTIs, CIPRO XR (500 mg once daily) in 444 patients was compared to ciprofloxacin immediate-release tablets (250 mg twice daily) in 447 patients for 3 days. Discontinuations due to adverse reactions thought to be drug-related occurred in 0.2% (1/444) of patients in the CIPRO XR arm and in 0% (0/447) of patients in the control arm.
In the clinical trial of cUTI and acute uncomplicated pyelonephritis (AUP) defined as infections occurring in premenopausal, non-pregnant women with no known urological abnormalities or comorbidities, CIPRO XR (1000 mg once daily) in 517 patients was compared to ciprofloxacin immediate-release tablets (500 mg twice daily) in 518 patients for 7 to 14 days. Discontinuations due to adverse reactions thought to be drug-related occurred in 3.1% (16/517) of patients in the CIPRO XR arm and in 2.3% (12/518) of patients in the control arm. The most common reasons for discontinuation in the CIPRO XR arm were nausea/vomiting (4 patients) and dizziness (3 patients). In the control arm the most common reason for discontinuation was nausea/vomiting (3 patients).
Table 2: Medically Important Adverse Reactions That Occurred In <1% of CIPRO XR Patients
|System Organ Class||Adverse Reactions|
|Body as a Whole||Abdominal pain
|Central Nervous System||Abnormal dreams
Convulsive seizures (including status epilepticus) Depersonalization
Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)
|Hepatobiliary Disorders||Liver function tests abnormal|
|Special Senses|| Diplopia
Kidney function abnormal
The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO XR. 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 (Table 3).
Table 3: Postmarketing Reports of Adverse Drug Reactions
|System Organ Class||Adverse Reactions|
Torsade de Pointes
Vasculitis and ventricular arrhythmia
|Central Nervous System||Hypertonia
Exacerbation of myasthenia gravis
|Hemic/Lymphatic|| Pancytopenia (life threatening or fatal outcome)
|Hepatobiliary||Hepatic failure (including fatal cases)|
|Infections and Infestations||Candidiasis (oral, gastrointestinal, vaginal)|
|Investigations|| Prothrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum)
|Skin/Hypersensitivity||Acute generalized exanthematous pustulosis (AGEP)
Serum sickness-like reaction
|Special Senses|| Anosmia
Adverse Laboratory Changes
Changes in laboratory parameters while on CIPRO are listed below:
Hepatic – Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.
Hematologic – Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.
Renal – Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.
Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.
Read the entire FDA prescribing information for Cipro (Ciprofloxacin)
NOTICE: The Drug Law Center is no longer accepting these type of cases. This page is strictly for informational purposes. We appreciate your cooperation and understanding by not contacting our office on these cases. We are actively investigating and prosecuting cases involving Valsartan cancers. For information on Valsartan lawsuits, look here.
The Cipro injury case attorneys at the Drug Law Center are currently evaluating and accepting new cases involving patients who suffered harm or wrongful death after taking the popular antibiotic medication.
Cipro (ciprofloxacin) is a popular antibiotic medication that is used to treat bacterial infections. The fluoroquinolone drug is also used to treat individuals exposed to the plague or anthrax. The medication is affected because it stops the growth of bacteria. The medicine is sold under its brand name Cipro and generic name ciprofloxacin. However, the drug can cause serious side effects including nausea, depression, diarrhea, or hallucinations. In addition, the FDA has warned users and doctors that Cipro and its generic medication ciprofloxacin might rupture tendons.
The History of Cipro
After Bayer, Inc scientists first synthesize the broad-spectrum antibiotic in 1981, it was found to inhibit cell division, thereby stopping the infection from growing. In 1987, the Food and Drug Administration (FDA) approved Cipro as the first oral broad-spectrum antibiotic in the fluoroquinolone class of drugs. The safety profile for the drug has been studied extensively and published in more than 32,000 publications. The FDA approved multiple uses for the drug including treatment for:
- Urinary tract infections
- Cystitis, urethritis, and kidney infections
- Acute cystitis
- Lower respiratory infection including tracheobronchitis, bronchitis, and pneumonia
- Skin infections
- Acute sinusitis
- Infectious diarrhea including campylobacter infection, shigellosis, and E. coli (Escherichia coli infection)
- Uncomplicated urethral and cervical gonorrhea STDs (sexually transmitted diseases)
- Enteric fever (typhoid fever)
- Inhaled anthrax
- Complicated urinary tract infection in children (17 years and younger)
Who Should Avoid Taking Cipro?
While Cipro has enormous benefits for individuals suffering certain bacterial infections, patients with a history of hypersensitivity to the active ingredients and components of ciprofloxacin should avoid taking the medication. This includes antibacterial drugs from the quinolone class of medications. This is because these medications have been associated with potentially irreversible severe adverse reactions and disabling side effects that include:
- Ruptured tendons
- Central nervous system effects
- Peripheral neuropathy
It is important to check with your doctor if you are suffering from any of the conditions listed below to discuss whether you should take Cipro (ciprofloxacin). These include:
- Clostridium difficile infection
- Heart transplant
- Lung transplant
- Kidney transplant
- Kidney impairment
- G6PD deficiency (Glucose-6-phosphate dehydrogenase deficiency)
- Q-T prolongation
- Low seizure threshold
- Kidney transplant
- Tendon inflammation
- Ruptured tendon
- Very rapid heartbeat
- Low bloodstream potassium levels
- Low bloodstream magnesium levels
- Pseudo tumor celebri
- Detached retina
- Slow heart beat
- Elevated pressure in the skull
Doctors often prescribe Cipro (ciprofloxacin) when all other antibiotics have proven to be ineffective when treating acute sinusitis, acute uncomplicated cystitis, and acute exacerbation of chronic bronchitis.
Certain medications negatively interact with Cipro and should not be taken concomitantly with the antibiotic. These include cisapride, tizanidine, terfenadine, and droperidol. Common medicines and substances that interact with Cipro include antacids, contraceptive medications, caffeine, multivitamins, ibuprofen, naproxen, diabetes medicines, didanosine buffered powder or tablets, cyclosporine warfarin, theophylline, sucralfate, and probenecid.
Patients must discuss side effects Cipro (ciprofloxacin) with their doctors if they have or have had any one of the following conditions including:
- Clostridium difficile infection
- Heart, lung, or kidney transplant
- Ruptured tendon
- Inflamed tendon
- Congenital Q-T changes
- Detached retina
- Pain or tingling sensation in the feeder hands
- Low bloodstream magnesium or potassium levels
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Torsades de Pointes (very rapid heartbeat)
- Low seizure threshold
- A severe reaction to fluoroquinolone class of medications
Cipro Side Effects
Like most antibiotics, Cipro (ciprofloxacin) has mild to serious side effects that may affect the health and well-being of the patient while taking the medication and after. Mild Cipro side effects include:
- Pounding heartbeat
- Fast heart rate
- Stomach upset or pain
- Popping sound
- Snapping sound
- Sudden Pain
- Blurry Vision
- Muscle tenderness
- Swollen muscles
- Bloody or watery diarrhea
- Insomnia including sleeping issues or nightmares
- Some form of loss of joint movement
Serious Cipro side effects include:
- Unsteadiness or clumsiness
- Breathing problems
- Allergic reaction including swelling of the tongue, lips or face, eyes, itching, or skin rash
- Feeling lightheaded
- Difficulty passing urine
- Irregular heartbeat
- Loosening, peeling, blistering or redness of the skin
- Persistent headaches
Benefits vs. Permanent Side Effects
In May 2016, the Food and Drug Administration (FDA) informed the public that it required drug manufacturers to place stronger warnings and more information in the Black box warning label concerning fluoroquinolone class medications including Cipro, Levaquin, and Avelox. More than 26 million patients in the United States take these three brand-name medications or their generic version every year.
In the release of the Drug Safety Communication, the FDA wrote that they are “advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweighed the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.” The communication went on to say that “for patients with these conditions, fluoroquinolones, should be reserved for those who do not have an alternative treatment option.”
This new addition to the Black Box Warning label comes after nearly eight years after the FDA advisory committee required that the drug manufacturer inform the public back in 2008 that taking these drugs could cause tendinitis and tendon rupture. By 2013, the FDA was claiming that these medications could potentially cause peripheral neuropathy (permanent nerve damage).
The FDA hopes that informing the public, doctors, patients, and the entire medical community that users will make a more informed decision before taking the medication. The advice that the antibiotic could cause potentially permanent damage to joint, tendons, muscles and nerves and the body central nervous system could make potential users reconsider what to do and instead take other antibiotic drugs available and the medical marketplace that has less potential serious side effects. The FDA is trusting the doctors will be discouraged from prescribing fluoroquinolone medications when other treatments are available.
Cipro and Aortic Bulges and Tears
A warning from the U.S. Food and Drug Administration has alerted users of quinolone drugs including Cipro (ciprofloxacin) that the drug could cause nerve and tendon damage. This information was released after new research studies had surfaced that correlated potentially fatal medical conditions to taking Cipro, Levaquin, Avelox and their generic counterparts. The FDA warns that these drugs could cause bulges (aneurysms) and tears (aortic dissection) during and after short-term or long-term use.
In 2015, published studies analyzed the effects of fluoroquinolones and their ability to cause severe permanent tendon damage. The researchers hypothesized that the antibiotic properties of these medications had the ability to break down the body’s collagen, which is why it affected the lining of the aorta that is made up primarily of collagen. The 2015 JAMA Medical Journal publication made the correlation between fluoroquinolones in the increased potential risk of developing aneurysms or dissections after only two months of taking the drug.
One researcher in the study said that “reducing unnecessary fluoroquinolone treatments and prolonged treatment courses might have possibly prevented more than 200 aortic aneurysms in population.
Even though the Food and Drug Administration was placing new requirements on drug manufacturers issuing new warnings about the serious side effects of taking fluoroquinolones including Cipro (ciprofloxacin), Bayer, Inc., Johnson & Johnson, and its subsidiary Janssen Pharmaceuticals have reaffirmed the benefits of the drug stating that:
“At Janssen, our first priority is the well-being of the people who use our medicines. We are reviewing the Drug Safety Communication and will continue our ongoing collaboration with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics… Levaquin as part of the important fluoroquinolone class of anti-ineffective prescription medications and its safety profile remains well known and established.”
As a part of the new directive from the Food and Drug Administration, officials are urging patients to tell their doctor immediately of any symptom involving tendon or nerve damage. Patients should expect to feel hallucinations, confusion, tendon or joint pain, muscle pain, pricking or tingling sensations in the feet or hands.
- Product Liability MDL Lawsuit Case Now Forming Ten Bellwether TrialsMarch 2017 – Drugmakers are facing product liability lawsuits from plaintiffs who filed cases in the US district court for the District of Minnesota. The plaintiffs are alleging that fluoroquinolone class drugs including Levaquin, Cipro, Avelox and their generic version are causing peripheral neuropathy. The judge in the case has decided to hear ten bellwether cases to help resolve more than 735 lawsuits that are pending in federal court as a fluoroquinolone multidistrict litigation (case 2642).
- $74 Million Bayer Cipro Settlement Resolves Major Class Action SuitJanuary 2014 – Final approval to settling a class action lawsuit has been granted by a California Superior Court judge. The case alleged that Bayer, Inc. conspired with other pharmaceutical companies to keep the cost of antibiotic generic drugs from competing against brand-name pharmaceuticals. They have denied any wrongdoing that it either breached or violated state and federal regulations and laws. Even so, the Company has agreed to a $74 million settlement to pay compensatory damages to all plaintiffs involved in the class action case.
- Using Cipro Might Be Linked to Stevens-Johnson SyndromeJune 2016 – Patients who have been prescribed Cipro (ciprofloxacin) may be experiencing the first indicators of a potentially fatal reaction to the medication. The Cipro rash has long been associated with various medications including fluoroquinolone antibiotics. The Food and Drug Administration has required the drug makers to include information on their Black Box Warning labels to immediately discontinue Cipro and other fluoroquinolone medications at the first sign of a skin rash.This is because the medication can easily cause Stevens-Johnson syndrome, where the body reacts by causing itching, fever, and inflamed pharynx. Over time, the rash can blister and detach from the skin’s outer layers. In some cases, Stevens-Johnson syndrome can exacerbate and evolve into a TEN (toxic epidermal necrolysis) condition that becomes life-threatening.
We Are Not Accepting Cipro Injury Monetary Compensation Cases
The Cipro injury case attorneys at the Drug Law Center are currently investigating, evaluating, and accepting lawsuit cases involving the popular antibiotic medication after it has caused dangerous nerve damage. We represent individuals who have been diagnosed with aortic distension, nerve damage, tendon pain, and aortic aneurysms and those who lost a loved one from a fatal injury caused by Cipro (ciprofloxacin).
If your doctor has diagnosed you with painful nerve damage, ruptured aorta, aortic tear, or another severe injury after you took Cipro, contact us today to obtain legal counsel. Let us begin the process of filing and resolving your lawsuit with a free, no obligation case evaluation to ensure your family receives a financial compensation they deserve.
To minimize your financial burden through the process of resolving your case, our law firm is currently postponing payment of all legal services. This means no upfront payment is required. Instead, we will receive payment only after we have successfully resolved your case through a negotiated settlement or through a jury award at the conclusion of your lawsuit trial.
Photo Credit Yvetta Fedorova
Jane Brody on health and aging.
Antibiotics are important drugs, often restoring health and even saving lives. But like all drugs, they can have unwanted and serious side effects, some of which may not become apparent until many thousands of patients have been treated.
Such is the case with an important class of antibiotics known as fluoroquinolones. The best known are Cipro (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin). In 2010, Levaquin was the best-selling antibiotic in the United States.
But by last year it was also the subject of more than 2,000 lawsuits from patients who had suffered severe reactions after taking it.
Part of the problem is that fluoroquinolones are often inappropriately prescribed. Instead of being reserved for use against serious, perhaps life-threatening bacterial infections like hospital-acquired pneumonia, these antibiotics are frequently prescribed for sinusitis, bronchitis, earaches and other ailments that may resolve on their own or can be treated with less potent drugs or nondrug remedies — or are caused by viruses, which are not susceptible to antibiotics.
In an interview, Mahyar Etminan, a pharmacological epidemiologist at the University of British Columbia, said the drugs were overused “by lazy doctors who are trying to kill a fly with an automatic weapon.”
Dr. Etminan directed a study published in April in The Journal of the American Medical Association showing that the risk of suffering a potentially blinding retinal detachment was nearly fivefold higher among current users of fluoroquinolones, compared with nonusers. In another study submitted for publication, he documented a significantly increased risk of acute kidney failure among users of these drugs.
The conditions Dr. Etminan has studied are relatively easy to research because they result in hospitalizations with diagnoses that are computerized and tracked in databases. Far more challenging to study are the array of diffuse, confusing symptoms suffered by fluoroquinolone users like Lloyd Balch, a 33-year-old Manhattan resident and Web site manager for City College of New York.
In an interview, Mr. Balch said he was healthy until April 20, when a fever and cough prompted him to see a doctor. Nothing was heard through a stethoscope, but a chest X-ray indicated a mild case of pneumonia, and he was given Levaquin. Although he had heard of problems with Levaquin and asked the doctor if he might take a different antibiotic, he was told Levaquin was the drug he needed.
After just one dose, he developed widespread pain and weakness. He called to report this reaction, but was told to take the next dose. But the next pill, he said, “eviscerated” him, causing pain in all his joints and vision problems.
Debilitating Side Effects
In addition to being unable to walk uphill, climb stairs or see clearly, his symptoms included dry eyes, mouth and skin; ringing in his ears; delayed urination; uncontrollable shaking; burning pain in his eyes and feet; occasional tingling in his hands and feet; heart palpitations; and muscle spasms in his back and around his eyes. Though Mr. Balch’s reaction is unusual, doctors who have studied the side effects of fluoroquinolones say others have suffered similar symptoms.
Three and a half months after he took that second pill, these symptoms persist, and none of the many doctors of different specialties he has consulted has been able to help. Mr. Balch is now working with a physical therapist, but in a phone consultation with Dr. David Flockhart, an expert in fluoroquinolone side effects at the Indiana University School of Medicine, he was told it could take a year for his symptoms to resolve, if they ever do disappear completely.
Guidelines by the American Thoracic Society state that fluoroquinolones should not be used as a first-line treatment for community-acquired pneumonia; it recommends that doxycycline or a macrolide be tried first. Mr. Balch didn’t know this, or he might have fought harder to get a different antibiotic.
Adverse reactions to fluoroquinolones may occur almost anywhere in the body. In addition to occasional unwanted effects on the musculoskeletal, visual and renal systems, the drugs in rare cases can seriously injure the central nervous system (causing “brain fog,” depression, hallucinations and psychotic reactions), the heart, liver, skin (painful, disfiguring rashes and phototoxicity), the gastrointestinal system (nausea and diarrhea), hearing and blood sugar metabolism.
The rising use of these potent drugs has also been blamed for increases in two very serious, hard-to-treat infections: antibiotic-resistant Staphylococcus aureus (known as MRSA) and severe diarrhea caused by Clostridium difficile. One study found that fluoroquinolones were responsible for 55 percent of C. difficile infections at one hospital in Quebec.
Fluoroquinolones carry a “black box” warning mandated by the Food and Drug Administration that tells doctors of the link to tendinitis and tendon rupture and, more recently, about the drugs’ ability to block neuromuscular activity. But consumers don’t see these highlighted alerts, and patients are rarely informed of the risks by prescribing doctors. Mr. Balch said he was never told about the black-box warnings.
Lack of Long-Term Studies
No one knows how often serious adverse reactions occur. The F.D.A.’s reporting system for adverse effects is believed to capture only about 10 percent of them. Complicating the problem is that, unlike retinal detachments that were linked only to current or very recent use of a fluoroquinolone, the drugs’ adverse effects on other systems can show up weeks or months after the treatment ends; in such cases, patients’ symptoms may never be associated with prior fluoroquinolone therapy.
No long-term studies have been done among former users of these antibiotics. Fibromyalgia-like symptoms have been associated with fluoroquinolones, and some experts suggest that some cases of fibromyalgia may result from treatment with a fluoroquinolone.
A half-dozen fluoroquinolones have been taken off the market because of unjustifiable risks of adverse effects. Those that remain are undeniably important drugs, when used appropriately. But doctors at the Centers for Disease Control and Prevention have expressed concern that too often fluoroquinolones are prescribed unnecessarily as a “one size fits all” remedy without considering their suitability for different patients.
Experts caution against giving these drugs to certain patients who face higher than average risks of bad reactions — children under age 18, adults over 60, and pregnant and nursing women — unless there is no effective alternative. The risk of adverse effects is also higher among people with liver disease and those taking corticosteroids or nonsteroidal anti-inflammatory drugs.
When an antibiotic is prescribed, it is wise to ask what the drug is and whether it is necessary, what side effects to be alert for, whether there are effective alternatives, when to expect the diagnosed condition to resolve, and when to call if something unexpected happens or recovery seems delayed.
At the same time, when an antibiotic is appropriately prescribed, it is extremely important to take the full prescription as directed and not to stop treatment when the patient simply begins to feel better.
Can Levofloxacin Cause Muscle and Joint Pain?
My patient reports muscle and joint pain after starting levofloxacin. Do fluoroquinolones cause these side effects? If so, how should they be managed?
| Response from Jodi H. Walker, PharmD
Adjunct Faculty, Albany College of Pharmacy, Albany, New York; Clinical Pharmacy Coordinator, VA Medical Center, Bath, New York
Fluoroquinolones (FQs), such as moxifloxacin, ciprofloxacin, and levofloxacin, are broad-spectrum, bactericidal antibiotics. Generally, FQs are well tolerated, and adverse events are mild. Healthcare providers are aware of the published data and black box warnings on FQ use and risk for tendonitis/tendon rupture. However, few case reports of arthralgias and myalgias associated with FQs have been published.
Arthralgias and/or myalgias can be a concerning adverse effect of FQs. O-Lee and colleagues performed a retrospective review of patients who received oral levofloxacin for sinusitis. Of 36 patients who responded to a survey, 25% reported arthralgias and/or myalgias beginning an average of 3 days (range, 1-5 days; standard deviation : 1.08) after starting therapy and resolving an average of 7.5 days (range, 1-21 days; SD: 5.6) after treatment cessation. Almost half of the patients discontinued therapy because of these adverse effects.
Fulminating musculoskeletal pain was reported in a 58-year-old man after his third exposure to ciprofloxacin. Treatment consisted of ciprofloxacin discontinuation and aggressive use of analgesics. Pain resolved 24 hours later. The patient had reported milder symptoms of muscle pain with previous courses of ciprofloxacin.
The mechanism of FQ-associated myalgia/arthralgia is unknown. One study evaluated muscle contraction and metabolism in 3 patients with FQ-induced myalgia. The investigators found that the patients had a pre-existing muscular anomaly that was revealed by FQ therapy.
Clinicians should note, however, that rhabdomyolysis has been reported with FQ use. In a comparison of 3 patients who developed rhabdomyolysis associated with FQs, symptoms including myalgias and arthralgias occurred within 1-4 days of FQ treatment.
Patients receiving FQs should be advised to contact their providers if they develop myalgias and/or arthralgias for further evaluation of the risks vs benefits of continued FQ therapy. Providers may consider discontinuation of FQ therapy and/or treatment with analgesics.
The author would like thank Marissa Chisdock, PharmD candidate, for her contributions in researching and compiling this response.