Hyperemesis gravidarum, also known as severe vomiting during pregnancy, can be a real pain. Most women expect some form of morning sickness while pregnant, but for others the problem is so severe that they turn to their doctors for help. Doctors and pharmaceutical companies have been promoting the off-label use of an anti-nausea drug called Zofran.
When pharmaceutical companies develop a drug, the FDA approves it for a narrow range of uses. If a physician or a pharmaceutical company promotes a drug for uses other than those approved, they run the risk of unintentionally harming vast numbers of people. Part of the reason for the FDA drug approval system is to protect consumers from dangerous side effects of drugs.
What is Zofran?
In the case of Zofran, testing resulted in its approval for the treatment of nausea after chemotherapy. As a category B pregnancy drug, the classification means that studies regarding the drug’s effects on pregnancy used animal testing only, without trials on humans. They FDA also provides the caveat that because of the B classification, it is prescribed during pregnancy only if clearly needed.
A big legal settlement
Unfortunately, some women who took the drug during pregnancy for their nausea noticed that their children experienced birth defects. One woman’s child was born with teratologic clubfoot deformity and amniotic band constriction after she took the drug. Other women have reported birth defects as well.
Off-label prescription use is a common practice, but a problem arises when a pharmaceutical company promotes a drug for an unapproved use. This practice has gotten the creator of Zofran, GlaxoSmithKline, into serious legal trouble. A 2012 settlement resulted in the company pleading guilty to unlawful promotion of certain drugs, and the court ordered the company to pay out a $3 billion settlement.
Questions about safety remain
Even though GSK pled guilty in the settlement, the birth defects issue remains. GSK was fraudulently promoting the off-label use of the drug, but the case did not address the defects claims. Some skeptics believe that evidence linking Zofran to birth defects is limited. However, some studies do link the drug with birth defects, and other medical experts argue that the company was aware of trends in the animal studies that may have indicated problems during pregnancy.
Although highly debated, evidence does link Zofran to certain birth defects. In addition, the stories of thousands of women are significant. A woman should have the information available to her about potential side effects of any drug that she is taking during pregnancy to avoid harm to her unborn child. Finally, the decision against GSK can potentially lend some credibility to the claim that the off-label promotion can possibly cause harm, and so any person who has experienced issues with Zofran may wish to seek more information regarding potential legal options.