Studies Find Links Between Zofran and Major Birth Defects

Recent epidemiological studies have shown a possible link between the anti-nausea drug Zofran and major birth defects.

The US Food and Drug Administration approved Zofran in 1991. It was manufactured to treat severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia. Some physicians have also prescribed the drug to pregnant women as a morning sickness treatment. Because pregnancies across the world have been exposed to ondansetron, which is an active ingredient in Zofran, researchers have started to study the drug’s effect on fetal development.

The study is currently being funded by the US Centers for Disease Control. Researchers from Harvard and Boston University have reviewed health records from a total of 10,383 pregnancies. Out of these women, only 15% sought medical attention to alleviate morning sickness. Women taking Zofran were 2.37 times more likely to deliver babies with cleft palate than women who received no treatment for their morning sickness.

A total of 96,968 birth records filed between 2002 and 2005 were researched at the University of Western Australia. While only 0.25% of the women were exposed to ondansetron in the first trimester, women who were prescribed ondansetron were 20% more likely to deliver babies with a major birth defect.

Another study done by Danish scientists reviewed birth record files in Denmark between 1997 and 2010. Their investigation included 903,207 pregnancies. By looking at the prescription and birth records together, the researchers found 1,368 Danish women that were prescribed ondansetron in the 13-year period. Compared to unexposed women, the study found that women taking Zofran were 4.8 times as likely to give birth to children with a rare congenital heart defect known as “atrioventricular septal defect.”

Because of the results of each study, multiple American families have filed lawsuits against the manufacturer of Zofran, GlaxoSmithKline. The claim states that the prenatal exposure to Zofran caused their children to be born with major birth defects. The parents allege that the company has been aware of Zofran’s risk while pregnant for two decades and that GlaxoSmithKline failed to disclose vital safety information to the public.

Despite years of evidence and growing lawsuit numbers, GSK still hasn’t changed Zofran’s label to include warnings of birth defects. If your child was born with a major birth defect as a result of the prescribed drug Zofran, you deserve compensation. At Balkin & Mausner, we will fight for you rights. For more information, contact us here or call us at 888-751-5908.