BOSTON - A popular drug many moms take to fight morning sickness is now the subject of a lawsuit claiming it causes birth defects.
Zofran has been approved since the early 1990s for use in preventing nausea and vomiting associated with chemotherapy and that can occur after surgery. It has proven to be a valuable treatment option for many people. Throughout the 24 years that Zofran has been available in the U.S., there has been little to no litigation claiming associations with birth defects until now. In an effort to find potential clients, plaintiffs' attorneys have spent millions of dollars on misleading, unsubstantiated advertisements and have filed numerous lawsuits seeking financial damages.
On October 27, 2015, the FDA denied a citizen position to change the pregnancy risk drug category for Zofran. The FDA stated that 'we do not agree with the Petition that the available data reviewed by FDA in connection with the Petition warrant a conclusion that ondansetron use during pregnancy poses an increased risk of fetal or maternal adverse outcomes.' The FDA also declined to notify physicians of the petitioner's views of the studies, finding that any 'notification to OB/GYNs that ondansetron may lead to adverse maternal or fetal outcomes is not necessary and could be misleading.' We appreciate the FDA providing clarity on the current state of the science for Zofran and hope the agency's letter will properly inform this litigation. We will continue working with the FDA, physicians and patients on monitoring and evaluating the safety and efficacy of our products."