Cowper Law is investigating claims regarding whether Zofran may have caused birth defects when used off-label to treat women in their first trimester of pregnancy.

Zofran (ondansetron) blocks the actions of chemicals in the body that can trigger nausea and vomiting.  Zofran is FDA approved and indicated to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation).  Zofran is not FDA approved for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery like, for example, in pregnant women.

In a 2011 study performed by a grant from the Centers for Disease Control and Prevention (CDC), Zofran was found to have doubled the risks of birth defects.  In two conflicting studies conducted in Denmark, however, one study followed over 600,000 women taking Zofran and concluded there was no increase risk while another Danish involving 900,000 pregnant women who took Zofran found a two-fold increase in infant heart defects.

On July 2, 2012, GlaxoSmithKline agreed to plead guilty and pay $3 billion to the U.S. Government to “resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.” 

The resolution was the “largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.” As part of this resolution, GlaxoSmithKline resolved its civil liability for, among other things, allegedly (1) promoting Zofran for off-label, non-covered use and (2) paying kickbacks to physicians to prescribe Zofran. As part of the resolution, GlaxoSmithKline did not concede nor admit liability in settling the civil claims, including those relating to Zofran. 

http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

If you or your child has been injured as a result of your taking Zofran, please call us today at 877.LAW.3707.