GlaxoSmithKline Failed To Warn on Risk GlaxoSmithKline failed to warn about the risk of birth defects with Zofran, a lawsuit filed in federal court in San Francisco alleges. The suit was filed on behalf of a couple whose daughter was born with severe congenital heart malformations in 2007, prompting her to undergo surgery at age four.
The FDA has only approved Zofran for severe cases nausea associated with chemotherapy and radiation in patients with cancer. The suit alleges that GSK marketed the drug as a safe and effective treatment for morning sickness.
The parents allege that their daughter would not have developed cardiac defects if GSK had warned that taking Zofran during pregnancy could cause birth defects.
GSK has faced allegations over Zofran’s birth defects
This is not the first time GSK has faced allegations over Zofran’s birth defects. In fact, the company pled guilty to criminal charges filed by the U.S. Department of Justice alleging that GSK promoted Zofran off-label for morning sickness.
Off-label means use constitutes a drug or medical device being used in a manner not approved by the U.S. Food and Drug Administration (FDA). Physicians can prescribe drugs off label, but it is illegal for companies to market their drugs for off-label uses.