Zofran is manufactured by GlaxoSmithKline or GSK as an anti-nausea medication. The US Food and Drug Administration approved the drug in 1991 for patients undergoing chemotherapy, radiation therapy, and for post-operative nausea. Despite the FDA only approving Zofran as anti-nausea medication under those specifications, the generic version of the drug, Ondansetron, has been prescribed to thousands women suffering from morning sickness during pregnancy, especially those experiencing hyperemesis gravidarum which is a rare disorder that causes extreme nausea and vomiting during pregnancy. By 2009 it was America’s most popular treatment for morning sickness, even though the FDA still hasn’t approved it for use by pregnant women.
For many women, Zofran and its generic version were so helpful in treating nausea and vomiting that it is alleged that GSK actively began to market Zofran as a morning sickness drug despite the FDA never approving it for morning sickness use. Several studies have highlighted an association between Zofran and severe birth defects, including an increased risk of heart arrhythmia, heart defects, and a cleft palate.
If you took Zofran to manage your morning sickness while pregnant and your child was born with one or more health issues, look into filing a Zofran lawsuit. Lawyers have been seeing a steadily increasing number of lawsuits across the country have been emerging by women and families whose children may have been affected by the use of Zofran while pregnant.
Zofran Side Effects
Common Zofran side effects include:
- Diarrhea
- Headache
- Fever
- Lightheadedness
- Dizziness
- Weakness
- Drowsiness
- Constipation
- Rash
- Blurred Vision
- Muscle Spasms
Contact a medical professional if you have more extreme Zofran side effects. A lawsuit has been filed against birth defects of those who have used the anti-nausea medication while pregnant, but some people experience serious side effects while taking the medication.
Birth Defects
Zofran is only approved for the use of nausea for cancer patients and for post-op patients; despite this the doctors keep prescribing Zofran to pregnant women because GSK markets it as a way to mitigate morning sickness. Since it has become more commonplace for pregnant women to be prescribed either the Zofran shot or the pills, the drug has been associated with a variety of birth defects such as:
- Musculoskeletal abnormalities
- Heart Arrhythmia
- Heart Valve Abnormalities
- Cleft Lip and/or Palate
- Jaundice
- Club Foot
Zofran lawsuit lawyers have been bringing cases of birth defects just like these to the courts since 2015. Court documents from those lawsuits show that GSK knew that the medication could present an “unreasonable risk of harm” to developing babies.
Zofran Birth Defects Lawsuit
Hundreds of women across the United States have filed a class action lawsuit for Zofran and individual lawsuits against them both for birth defects and for illegally promoting it as a morning sickness drug when it was never approved for those purposes.
The current class action lawsuit for Zofran as well as individual lawsuits alleges that GSK actively marketed Zofran off-label as an effective treatment for a common pregnancy symptom when the drug was not approved for that use. Off-label marketing is the promotion of a drug for a use that is not approved by the FDA.
Evidence has been presented in courts asserting that GSK knew it wasn’t safe for pregnancy when they tested it on animals, showing evidence of toxicity, birth defects, and intrauterine deaths. Lawsuits allege that since no human trials were done on pregnant women because testing was continuously delayed, the women who have been prescribed the medication over the years were treated as unknowing test subjects.
In many of these cases, the family had no history of birth defects and genetic testing didn’t detect any genetic abnormalities, but the mothers were all given Zofran to ease their morning sickness.
Get Legal Help from an
Attorney at Parker Waichman
At Parker Waichman, your family is our priority. If you took Zofran to manage your morning sickness while pregnant and your child experienced one or more birth defects linked to the drug, our Zofran lawsuit attorneys will help you explore the cause to find out if it was Zofran related. We will work tirelessly to make sure you and your loved ones are well taken care of during a trying time.
Our firm has extensive experience in litigation against big pharmaceutical companies like GlaxoSmithKline. Parker Waichman’s dedicated attorneys will walk you through every step of your Zofran lawsuit. Compensation amounts will vary from GSK for your child’s medical bills and any loss of income you may experience due to dealing with your child’s health defects can be achieved. Contact us today by filling out our online form or call 1-800-YOURLAWYER (1-800-968-7529) for a free consultation about your case; you may be entitled to compensation.
