Zofran (ondansetron) is a medication approved by the FDA to prevent nausea and vomiting in patients who have received chemotherapy cancer treatment, radiation therapy, or surgery. Lawsuits are pending against drug maker GlaxoSmithKline who is accused of marketing ondansetron to mothers as a safe and effective solution for morning sickness, despite potential risks to the unborn.
Zofran is an anti-nausea medication which can be administered prior to chemotherapy, radiological treatment, or surgery to reduce the risk of vomiting. It is a 5-HT3 antagonist which decreases nausea and vomiting by blocking serotonin and increasing gastric emptying. In recent years Zofran has been used by pregnant women to reduce the extreme symptoms of morning sickness. In fact, lawsuits allege the manufacturer, GlaxoSmithKline, promoted the product for this use even though the FDA had not approved this medication for this purpose. It is estimated that over a million women may have used Zofran to combat morning sickness. Fewer women have used it to combat hyperemesis gravidarum, which is a severe condition of morning sickness and nausea which can lead to dehydration and weight loss.
Unfortunately, reports now indicate Zofran may be linked to birth defects and heart issues and may not have been safe for consumption by pregnant women. Zofran is classified by the FDA as a Pregnancy Category B drug, which means that studies have not conclusively identified risks in animal studies, but it is not considered safe. It is important that women discuss taking Zofran with their doctors if they are pregnant or expect to become pregnant.
GlaxoSmithKline is a global healthcare company responsible for manufacturing, researching, and developing a broad range of products in the pharmaceutical, vaccine, and consumer health industries. GlaxoSmithKline was formed in 2000 when Glaxo Wellcome and SmithKline Beecham merged, although the genesis of the company can be found in London’s Plough Court Pharmacy in the 1700s. Located in Brentford, London, GlaxoSmithKline is considered the world’s sixth largest pharmaceutical company measured by revenue. GlaxoSmithKline’s market focus is manufacturing medications and vaccines to combat major diseases and conditions including infections, cancers, asthma, digestive conditions, and diabetes. Currently their most popular selling medications are Lamictal, Flovent, Augmentin, and Advair.
In recent years GlaxoSmithKline has been charged and convicted of several criminal charges resulting in large payouts which have exceeded $3 billion dollars. GlaxoSmithKline reportedly promoted several medications, including Paxil and Wellbutrin, for conditions in which they were not approved. Civil cases were also settled for Avandia with claimants arguing that GlaxoSmithKline failed to provide sufficient safety data for its safe use.
Mothers who were prescribed Zofran for morning sickness may have unwittingly exposed their babies to unreasonable risk of harm, a claim that claimants argued GlaxoSmithKline had known about as early as 1992 and failed to report to mothers. Lawsuits were filed by women who accused the company of marketing their product to expectant mothers and paying doctors to prescribe it even though the FDA had not approved Zofran for this use. Lawsuits filed against GlaxoSmithKline argue that the company had a duty to ensure Zofran was safe for use by pregnant women prior to its use, but the company failed to evaluate the risk prior to selling it. After the company had knowledge of potential dangers the lawsuits also alleges the company failed to warn the public about dangerous side-effects. Lawsuits also claim GlaxoSmithKline manufactured a defective drug and then falsely and fraudulently foisted it on unsuspecting women.
If you have taken Zofran for morning sickness and have had a child with a birth defects you may be entitled to compensation. Common birth defects which may be caused by the unauthorized use of Zofran include heart defects, including septal defects, cleft lip, cleft palate, club foot and Craniosynostosis.