Taking Zofran while pregnant may cause cleft lip, cleft palate or heart defects including atrial septal defect (ASD) and ventricular septal defect (VSD).
The problem comes down to a really simple set of facts.
Fact #1: Prescription drugs cannot be promoted by drug marketers for off-label purposes — a rule that helps protect patients from dangerous drugs or drugs that have not been sufficiently studied in a given set of patient groups.
Fact #2: Zofran was never approved to treat nausea in pregnant women — meaning women who took Zofran during their pregnancy to treat their nausea did so “off-label.”
Fact #3: GlaxoSmithKline promoted Zofran for this off-label use, in turn perhaps endangering countless women and their unborn children to serious health complications and risks.
Taking a medicine during your pregnancy is one of the most carefully calculated decisions of most women’s lives… women spend hours talking with their doctors and weighing the pros and cons before they begin taking a new medication or beginning a new regime that could potentially affect their unborn child.
For all too many women, though, they were not able to carefully calculate the pros and cons of taking Zofran to treat severe morning sickness. Instead, they were wrongly told, by way of off-label promotion, that taking Zofran during pregnancy was perfectly safe for women and their unborn children.
When a pharmaceutical company promotes an off-label use of a drug even though they did not verify its safety and receive FDA-approval for that specific use, they are playing with fire.
In 2012 the U.S. Department of Justice filed a lawsuit against GlaxoSmithKline for promoting a handful of their drugs for off-label uses. The lawsuit was eventually settled for $3 billion.