In the past month, at least three new lawsuits have been filed over birth defects parents allege were caused by Zofran, the popular anti-nausea medication prescribed for off-label use during pregnancy by mothers. This case, filed in California Superior Court on March 30, 2015, follows two others: one filed in the Eastern District of Pennsylvania on February 12, and another in the District of Massachusetts on February 16. Each case alleges congenital abnormalities, including heart defects, after the mothers were prescribed Zofran for nausea and vomiting associated with pregnancy…a use not approved by the FDA when the drug was approved for market.
The court cases allege, among other things, that the maker of the drug, GlaxoSmithKline, has received more than 200 reports of birth defects in children who were exposed to Zofran during early pregnancy. Glaxo is also being accused of improperly marketing Zofran to treat pregnancy-related nausea and vomiting, and one lawsuit even notes that Glaxo previously agreed to pay $3 billion to settle charges with the U.S. Department of Justice regarding the marketing of a number of other medications. This prior settlement with the U.S. government included allegations that Glaxo had improperly marketed Zofran to treat morning sickness…the very same claim now asserted by the plaintiffs.
Recent research by scientists with the University of Colorado, Stanford University, and London’s Royal Free Hospital reveled that when taken during pregnancy, Zofran does in fact cross the placenta to reach the developing fetus, and remains longer with the baby than the mother due to a longer half-life (i.e., the elimination rate of the drug in the body). This was not the first study done regarding these issues. A previously published study from the journal Clinical Pharmicokinetics, showed that samples taken from 41 women given Zofran prior to surgical pregnancy termination procedures revealed much higher concentrations of the drug within fetal tissues than was anticipated.