The Problems With Zofran And Pregnant Women

by Terry Bryant

Zofran, known by its generic name ondansetron, is among the most effect anti-nausea drugs on the market and has been approved for use since 1991. Until recently, it was also regularly prescribed for off-label purposes, particularly to pregnant women suffering from morning sickness. A 2013 Danish study seemed to support this approach as well, claiming that after reviewing the details of 600,000 Danish births, there was no reason to believe that ondansetron increased the risk of birth defects. Now, though, researchers have reason to worry that this is not the case at all, and that the drug may cause serious complications in newborns.

GlaxoSmithKline has pushed Zofran on doctors everywhere, coaxing them into prescribing the medication to pregnant women to improve bottom lines. The company has had to pay for this unethical behavior, in the form of a $3 billion judgment to the U.S. Department of Justice.

A more in-depth study of those same Danish birth registries, one that followed 900,000 women, found much different results than the initial analysis. The second study concluded that newborns exposed to ondansetron were twice as likely to be born with serious heart defects. Alarmingly, ondansetron has been shown to pass into the placenta readily, and any pregnant woman who takes it is likely exposing their child to the medication.

Although the FDA hasn’t called for any safety alerts or recalls, it is likely that more and more studies will reach the same conclusion. It is also likely that GlaxoSmithKline will face additional legal pressure in the future, so any family that has been affected by ondansetron will be able to get thorough assistance from a drug injury attorney.