Zofran (ondansetron), is an anti-nausea drug sometimes prescribed to pregnant women to treat morning sickness, or “nausea and vomiting of pregnancy” (NVP). Sadly, the use of Zofran during pregnancy has been linked to several types of birth defects, including hypospadias.
Hypospadias affect boys. It is a birth defect in which the opening of the urethra is not at the tip of the penis. Surgery is required, during infancy, to correct the defect. Multiple surgeries are sometimes required to correct all of the problems in stages. In some cases the surgery is not successful.
Zofran Not Approved for Morning Sickness
Zofran is not approved for use in pregnant women, but until 2013, there had not been a drug on the market for treating morning sickness in 30 years. When the U.S. Food and Drug Administration (FDA) approved Zofran to treat and prevent nausea in cancer patients, in 1991, GlaxoSmithKline (GSK) saw the void as an opportunity to make massive profits. The drug maker engaged in and aggressive and illegal off-label marketing campaign, pushing Zofran as a safe treatment for pregnant women.
2004 Zofran Study
A study published in the British Journal of Obstetrics and Gynaecology (BJOG), in 2004, found a potential link between Zofran use and hypospadias. In the group that was studied there was a much higher than expected rate of hypospadias in sons of women who took the drug during pregnancy, but the sample size was too small to say conclusively that there is an increased risk. The study authors warned that safety data on Zofran is lacking and more research is needed.
