Information about Zofran.

At least 4 studies raise concern over potential Zofran birth defects

July 26th, 2015

At least 4 studies have linked the anti-nausea drug Zofran (or its generic equivalent ondanestron) to an increased risk of birth defects. The drug’s manufacturer GlaxoSmithKline is facing increasing scrutiny and threats of Zofran lawsuits due to women who have come forward and alleged that the drug caused side effects such as cleft palate, heart defects and other birth defects.

The studies include one conducted by Harvard researchers at the U.S. Centers for Disease Control, a 2013 study published in BioMed Research International and a 2014 study published in Reproductive Toxicology. Most studies found that patients who used Zofran during pregnancy were 2 to 4 times more likely to give birth to a baby with birth defects than women who did not take the drug.

Released in 1991, Zofran was originally intended for use in surgery patients and cancer treatment patients, but has increasingly been given to pregnant women to combat morning sickness. The number of off-label prescriptions of Zofran is estimated to be more than 1 million every year.


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