A Zofran lawsuit may be an option for patients who took the medication and suffered severe Zofran side effects, including heart complications. Plaintiffs claim that the drug maker allegedly failed to disclose increased risks of birth defects to pregnant women who were prescribed the drug to treat morning sickness. Affected patients and their families may be able to file a lawsuit and recover compensation with the help of a Zofran lawsuit attorney.
For more information, contact Attorney Group if you or a loved one took Zofran and suffered from severe side effects, or if you or a loved one took Zofran during pregnancy and delivered a baby with birth defects. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated attorney who can assist you throughout the legal process.
What is Zofran?
Zofran is approved by the U.S. Food and Drug Administration (FDA) as a treatment for nausea and vomiting in chemotherapy and surgery patients. In some cases, the drug has been prescribed “off-label” to treat morning sickness pregnant women may experience. Zofran is a 5-HT3 receptor antagonist that works by blocking serotonin, a neurotransmitter primarily located in the gastrointestinal tract. Serotonin induces nausea and vomiting, and Zofran acts to inhibit these effects of serotonin.
Zofran Side Effects
Like many drugs, Zofran may cause adverse reactions or side effects. While some of these side effects are temporary or mild, otherscan be severe and may cause significant complications or injury. Common Zofran side effects include constipation, diarrhea, fever, headache, blurred vision, itching and rashes, and more severe side effects may potentially indicate hearth rhythm changes. Patients should be aware of:
- Shortness of breath
- Irregular heartbeat
In some cases, patients taking Zofran may allegedly experience heart complications leading to a severe and potentially fatal heart arrhythmia called Torsades de Pointes. Cardiac risks prompted the FDA to issue consumer warnings regarding Zofran dosages over 16 mg and led to the discontinuation and recall of the 32 mg dosage of the drug.
Other Zofran Risks
Use of Zofran during pregnancy has also been allegedly linked to other potential risks to the mother, especially pregnant women suffering from morning sickness or electrolyte imbalance brought on by vomiting. Other potential risks include Serotonin Syndrome, which can cause changes in behavior and cognition, including irritability, confusion, neuromuscular changes and autonomic instability.
Risks to children taking Zofran have also been reported. A 2006 FDA report examining deaths of children under 16 who took Zofran listed syncope, palpitations, bradycardia, and cardiac arrhythmias among known adverse reactions.
GlaxoSmithKline (then Glaxo Wellcome) reportedly received a warning in 1999 from the FDA regarding alleged wrongful marketing practices of medications, including inadequately representing the risks and side effects of Zofran. In 2011, the drug maker was required to conduct a study to analyze the cardiac side effects of the drug, and researchers found that doses more than 16 mg increased the risk of Torsades de Pointes. The manufacturer subsequently recalled the 32 mg dosage in 2012.
GlaxoSmithKline was also ordered to pay $3 billion to the U.S. Department of Justice in 2012 to settle allegations of wrongful “off-label” (unapproved by the FDA) promotion of drugs, including Zofran to pregnant women as a treatment for morning sickness.
Do You Have Questions About Zofran Side Effects?
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Zofran may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
The Time You Have to Pursue a Claim is Limited. Contact Us Today.
For more information, contact Attorney Group. You can fill out the form on this page or contact us by phone or email.
After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.