FDA Says One Dosage of Zofran Off Market Because of Heart Risk

The Food and Drug Administration Dec. 4 said it is notifying health care professionals that the 32 mg single intravenous dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will not be marketed any longer because of the potential for serious cardiac risks.

This dose has been removed from the Zofran drug label, the agency said. Zofran is manufactured by GlaxoSmithKline, which is based in the United Kingdom.

FDA said it is working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market.

In June, FDA said the 32 mg ...