- Popular nausea drug Zofran can cause serious health issues
- SIDE EFFECTS
- Clinical Trials Experience
- Prevention Of Chemotherapy-Induced Nausea And Vomiting
- Prevention Of Radiation-Induced Nausea And Vomiting
- Prevention Of Postoperative Nausea And Vomiting
- Postmarketing Experience
- What is Serotonin Syndrome?
- Symptoms of Serotonin Syndrome
- Don’t Wait to Get Help
- SIDE EFFECTS
- Prevent Headaches Caused By A Common Prescription Drug
Popular nausea drug Zofran can cause serious health issues
Most people want to believe that prescription medications are safe for use as recommended by doctors. However, even when most people take a drug without any serious issues, other people can have reactions. These could range from allergies to death in severe cases. Some drugs can also cause birth defects if taken during pregnancy. That’s why drugs administered to pregnant women undergo much more scrutiny than other medications.
Zofran is a drug that many doctors choose to prescribe to people who suffer with chronic nausea or vomiting. That can include morning sickness during pregnancy. It’s important to understand that like most drugs, Zofran carries a risk of side effects and unintended consequences for its users.
Zofran is a drug with problematic side effects
Zofran, the brand name of the drug also called Ondansetron Hcl helps to control nausea and vomiting. Many times, it is used for people receiving cancer treatments, such as radiation therapy or chemotherapy. Doctors also prescribe it to pregnant women who have extreme or debilitating morning sickness. The mechanism of the drug involves blocking serotonin, which can cause vomiting. Doctors will look at your liver health and weight when deciding how much of the drug you should take.
While Zofran can offer relief to some patients who can’t eat or struggle with chronic nausea, it can also create severe side effects. These side effects include:
- stomach pain
- muscle spasms
- muscle stiffness
- blurry vision
- chest pain
- irregular heartbeat
These side effects could be a warning of a severe reaction or intolerance to the drug. People suffering them should advise their doctor as soon as possible. In some cases, however, the side effects may surface after the drug has already caused damage to the body.
Zofran can cause damage to many organs including the heart or liver. Those with pre-existing conditions may be at higher risk for severe reactions to this drug. It can also pose some additional risks during pregnancy, meaning that it should only be taken when absolutely needed.
Zofran isn’t actually approved for pregnant women
While many doctors rely on this medication to help women with hyperemesis grandivarum (intense sickness and dangerous vomiting) during pregnancy, Zofran isn’t actually approved for use during pregnancy. There simply isn’t enough research to ensure the safety of the developing fetus when taking the drug.
One condition linked to Zofran is Serotonin Syndrome, which causes increased nerve cell activity in the brain. It is possible that this drug could impact the serotonin levels and brain development of the infant, as well as the mother, if taken during pregnancy. If you’ve given birth to a child with a potential birth injury and took Zofran while pregnant, you may need to consider your options and inform yourself about your rights as a parent and a patient.
PRECAUTIONS: Before taking ondansetron, tell your doctor or pharmacist if you are allergic to it; or to other serotonin blockers (e.g., granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: irregular heartbeat, liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).Ondansetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ondansetron, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ondansetron safely.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because a very serious interaction may occur: apomorphine.If you are currently using the medication listed above, tell your doctor or pharmacist before starting ondansetron.Before using this medication, tell your doctor of all nonprescription and prescription medication you may use, especially of: tramadol.Ask your doctor or pharmacist for more details.Many drugs besides ondansetron may affect the heart rhythm (QT prolongation), including dofetilide, pimozide, procainamide, amiodarone, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using ondansetron, report all medications you are currently using to your doctor or pharmacist.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ZOFRAN. A causal relationship to therapy with ZOFRAN was unclear in many cases.
Prevention Of Chemotherapy-Induced Nausea And Vomiting
The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24mg dose of ZOFRAN orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin greater than or equal to 50 mg/m2) were: headache (11%) and diarrhea (4%).
The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (primarily cyclophosphamide-based regimens) are shown in Table 3.
Table 3: Most Common Adverse Reactions in Adultsa for the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy
Less Common Adverse Reactions
Central Nervous System: Extrapyramidal reactions (less than 1% of patients).
Hepatic: Aspartate transaminase (AST) and/or alanine transaminase (ALT) values exceeded twice the upper limit of normal in approximately 1% to 2% of 723 patients receiving ZOFRAN and cyclophosphamide-based chemotherapy in US clinical trials. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes is unclear.
Liver failure and death has been reported in cancer patients receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.
Integumentary: Rash (approximately 1% of patients).
Other (less than 2%): Anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures. Except for bronchospasm and anaphylaxis, the relationship to ZOFRAN is unclear.
Prevention Of Radiation-Induced Nausea And Vomiting
The most common adverse reactions (greater than or equal to 2%) reported in patients receiving ZOFRAN and concurrent radiotherapy were similar to those reported in patients receiving ZOFRAN and concurrent chemotherapy and were headache, constipation, and diarrhea.
Prevention Of Postoperative Nausea And Vomiting
The most common adverse reactions reported in adults in trial(s) of prevention of postoperative nausea and vomiting are shown in Table 4. In these trial(s), patients were receiving multiple concomitant perioperative and postoperative medications in both treatment groups.
Table 4: Most Common Adverse Reactions in Adultsa for the Prevention of Postoperative Nausea and Vomiting
In a crossover study with 25 subjects, headache was reported in 6 subjects administered ZOFRAN ODT with water (24%) as compared with 2 subjects administered ZOFRAN ODT without water (8%).
The following adverse reactions have been identified during post-approval use of ondansetron. 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.
Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported.
Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylactic reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron.
Liver enzyme abnormalities.
Oculogyric crisis, appearing alone, as well as with other dystonic reactions.
Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.
Read the entire FDA prescribing information for Zofran (Ondansetron Hydrochloride Tablets and Solution)
Your body produces serotonin to ensure that the nerve cells and brain function properly. The chemicals in your body work together to make sure everything function as it should. However, recent reports show that Zofran use may be lead to serotonin syndrome.
Zofran is medication that is often prescribed to patients who underwent surgery or chemotherapy. The medicine treats vomiting and nausea that may result because of the different procedures. The drug is part of the antiemetic class, with selective 5-HTC3 receptor antagonist. Because the drug introduced additional serotonin into the body, users may experience serotonin syndrome.
What is Serotonin Syndrome?
Serotonin syndrome occurs when the body accumulates too much serotonin. Symptoms usually begin manifesting within the first few hours of taking a new drug.The Food and Drug Administration placed a warning label on Zofran that says,
The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms of Serotonin Syndrome
Mild symptoms include:
- Dilated pupils
- Agitation or restlessness
- Rigid muscles
- Loss of muscle coordination
- Rapid heart rate and high blood pressure
If left unaddressed, serotonin syndrome can cause serious injuries and can prove fatal. Symptoms of severe cases include:
- Irregular heartbeats
- High fever
Don’t Wait to Get Help
If you took Zofran and exhibited any of these symptoms, it is imperative that you receive proper care. If you were seriously hurt because of the drug, contact our Cleveland attorneys today.
Contact our firm for a free, no-obligation consultation today.
Prevent Headaches Caused By A Common Prescription Drug
A zofran headache is a common side effect of the prescription drug zofran. This drug is used to prevent nausea and vomiting in a variety of patients. It is used a lot with chemotherapy patients and is given post-op to decrease the risk of nausea from anesthesia. It has also been prescribed for severe nausea and vomiting in pregnant women.
But why does the medication cause zofran headaches? We need to look at the way zofran works to understand. It is in a class of drugs called 5-HT3 receptor antagonists. These drugs will block the action of serotonin, which is a chemical found in the brain thought to trigger nausea and vomiting. Zofran will reduce the serotonin, therefore reducing the liklihood of nausea and vomiting.
A headache is thought to begin in the trigeminal nerve, which is located in the brain stem. This nerve carries sensory impulses to and from the face. When stimulated, this nerve will signal the release of serotonin. The serotonin acts as a filter to screen out unimportant signals and will admit signals that demand attention, such as your name being called, a baby’s cry or an unusual sound that could mean danger. The more serotonin present, the greater the screening action. The serotonin will also counteract pain signals in the nerve to reduce headaches. Studies has shown that when given a drug that depletes the serotonin in your brain a headache can result. Since zofran is in the class of drugs that deplete serotonin, it would be reasonable to assume that it could cause a zofran headache.
If you are taking zofran and are having zofran headaches there are a few things that you can do to help. First of all, get plenty of sleep. The more rested you are the better your body may be able to adapt to the medication. Try to maintain a consistent sleep pattern, going to bed and awakening at the same time every day, even on weekends. Drink plenty of fluids to keep well hydrated. Take over the counter headache medicine after taking zofran, if allowed. This may help to counteract the zofran headache. Check with your doctor first to see which headache medicine he recommends.
Zofran has been called a miracle drug by a lot of people, especially people with cancer and pregnant women. It has enabled them to carry on a normal life despite the challenges of their disease or condition. Always make your doctor aware of any side effect that you may be experiencing from your medications. Let him know of any other medications that you may be taking also, including vitamins and herbs. If nausea and vomiting is severe and zofran is the only medication that helps, a zofran
headache may be a small price to pay for some relief.
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