Several lawsuits filed against the makers of Zofran, GalxoSmithKline, suggest that Zofran may cause birth defects.
The US District Court for Massachusetts has been flooded with nearly 200 lawsuit against the makers of Zofran. The lawsuits, arising from across the United States, were consolidated to the Massachusetts’ court where they will proceed as a multi-district litigation.
In 1991 the Food & Drug Administration (FDA) approved the use of Zofran to treat extreme nausea arising from radiation therapy, chemotherapy, and for some post operative procedures. However, FDA never approved Zofran as a safe drug for pregnant women to use.