What is Zofran?
Zofran (generic: ondansetron) is an anti-nausea medication manufactured by GlaxoSmithKline (GSK). The drug works by blocking the actions of chemicals in the body that can trigger nausea and vomiting. Zofran was approved by the U.S. Food & Drug Administration (FDA) in January 1991.
What’s the Problem?
When taken by pregnant women for morning sickness, Zofran has been linked to a large number of severe, potentially life-threatening birth defects. Using Zofran to treat morning sickness is done so in an “off-label” capacity, meaning this use has not been approved by the U.S. Food & Drug Administration (FDA). Mothers taking Zofran during pregnancy are also at risk of developing serotonin syndrome or arrhythmias (abnormal heart rhythm) if specific conditions are met.
Why is Using a Medication “Off-Label” Dangerous?
Using a drug off-label may be dangerous to a patient’s health in unpredictable ways, because of the often inadequate data regarding that drug’s safety and effectiveness when used for an unapproved purpose.
Which Birth Defects has Zofran Been Linked to?
When taken by expecting mothers during pregnancy (particularly during the first trimester), Zofran has been linked to a large number of heart, kidney, craniofacial and other birth defects. Please visit our Zofran Lawsuit page for a complete list of defects associated with Zofran.
Are There Side Effects That I Should Be Worried About?
You should contact your doctor immediately if you experience any of the following side effects while taking Zofran: agitation or restlessness, confusion, high blood pressure (hypertension), loss of muscle coordination / twitching muscles, heavy sweating, diarrhea, headache, high fever, seizures, rapid / irregular heartbeat or unconsciousness.
Is It Safe to Use Zofran With Other Drugs?
Always talk to your doctor before taking any other prescription or over-the-counter (OTC) medication while being treated with Zofran. Many drugs commonly prescribed during pregnancy, such as SSRI antidepressants, may interact with Zofran, increasing the risk of serious side effects to users and their unborn babies. Also, many other medications that may prolong the QT interval such as antifungals may cause arrhythmias (abnormal heart rhythm) and should be taken with caution.
I Have Terrible Morning Sickness. Should I Take Zofran?
No. Zofran has been prescribed to many woman for the treatment of morning sickness during pregnancy, but this an “off-label” use that has not been approved by the FDA.
Is There a Time Limit to File a Lawsuit?
There’s a maximum time limit to file a federal lawsuit defined by every state, known as the “statute of limitations,” or SOL. However, this timeframe is usually long enough to allow most injured parties to fall into it. Contact our lawyers today to learn more about your legal rights.
How Much Does it Cost to File a Claim?
Our lawyers work on a contingency fee basis, which means that there are no fees to you unless the case is won in a court and compensation is secured for your family.
What Damages Could I Recover?
If our lawyers determine that you have a legitimate claim, you may be eligible to receive compensation for medical expenses, lost wages, pain and suffering, disability, decreased quality of life and other damages.
Has a Class Action Been Filed?
No class action lawsuit has yet been filed in the Zofran litigation. However, federal complaints filed over birth defects allegedly caused by the drug have been consolidated into a multidistrict litigation (MDL) in the District of Massachusetts before Judge Dennis F. Saylor, IV. MDLs are different from class actions in that each plaintiff is entitled to their own attorney, their cases are handled separately, and they will receive an individual settlement based upon their particular injuries and damages caused by Zofran.
Have There Been Any Settlements?
In July 2012, the U.S. Justice Department ordered GSK to pay a $3 billion settlement to resolve allegations that it illegally marketed several medications, including Zofran to pregnant women for morning sickness. The settlement does not provide any payments to pregnant women who had a baby with a birth defect after taking Zofran. It does, however, add strength to legal claims from pregnant women who accuse GSK of negligence for marketing Zofran without adequate warnings about the risk of birth defects.