Originally developed to treat nausea and vomiting in cancer patients, Zofran has been prescribed off-label to treat morning sickness in moms-to-be over the years. Ironically, this drug, only approved post-operatively for chemotherapy patients, has been associated with birth defects—and has subsequently seen a rising volume of lawsuits as more pregnant women are affected.
If you took Zofran during pregnancy and your baby was born with birth defects, speak to a Zofran Attorney now. You may be entitled to financial compensation.
GlaxoSmithKline’s Original $3 Billion Settlement
The concerns regarding the safety and promotional policies of Zofran aren’t new. In 2012, pharmaceutical manufacturer GlaxoSmithKline pleaded guilty for unlawfully promoting prescription drugs, failing to report safety data and false price reporting practices for several of its drugs. The $3 billion settlement marked the largest health care fraud settlement in U.S. history at the time – as well as the largest payment by a drug company.
The case resolved the company’s civil liability for Paxil, Wellbutrin, Advair, Zofran and Lamictal for non-FDA approved uses. Of particular concern was the prescription of Zofran to pregnant women, as it was only given the green light for post-operative nausea at the time. Further allegations were made about kickbacks the pharmaceutical company paid to healthcare professionals as well. Though the company settled for this off-label marketing in 2012, Zofran has continue to be prescribed to pregnant women and has continued to cause birth defects in their babies.
Zofran Birth Defects a Result of Illegal Marketing
For many pregnant women, morning sickness is debilitating and difficult to stop, particularly if they cannot keep food or fluids down. The most extreme form of morning sickness, called hypermesis gravidarum can sometimes rival the nausea that accompanies chemotherapy and is sometimes treated with the same drug. While Zofran is considerably effective at treating the nausea and vomiting in both instances, it is not approved for both. Little to no testing was done on its safety during pregnancy, and like most other pharmaceutical drugs, was not approved for the purpose.
Initially, the lack of research on the matter meant that there was not a way to prove that birth defects were a result of Zofran. A study published in February 2013, however, painted a troubling picture of the effects of this off-label prescription by casting a wider net for relevant data. The researchers studied 900,000 pregnancies over a 13-year window, expanding the reach and accuracy of a study that had once brought no statistically relevant data to the table on the matter. Danish researchers presented their findings at the International Society of Pharmacoepidemiology meeting in Montreal in August 2013 – findings that indicated a twofold increase in congenital heart defects during the first trimester of a woman’s pregnancy when she took Zofran or the generic version of the drug, called ondansetron.
Zofran Lawsuits Continue Mounting
GlaxoSmithKline has not seen the last of the Zofran birth defect lawsuits, as more research and data is being presented on the risks associated with taking the drug during pregnancy and the lack of warning given to both physicians and expecting mothers. Just this February, GSK was hit with another claim by a woman who said her daughter was born with congenital hearth defects that have necessitated 13 different surgeries. The verdict has yet to be reached.
Get the Help You Need
There are several other drugs approved for the treatment of extreme morning sickness—drugs that don’t carry the same potentially fatal risks for a developing baby. If you or someone you know has been affected taken Zofran while pregnant and had a baby with birth defects as a result, you may be eligible to make a Zofran claim. It’s a good idea to speak with an attorney who has experience with mass torts like the Zofran birth defect case, as they can help you be successful with your claim moving forward.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.