FDA: 32-mg dose of Zofran to be removed from market
The 32-mg, single IV dose of ondansetron hydrochloride no longer will be marketed because of the potential for serious cardiac risks, according to the FDA.
Ondansetron hydrochloride (Zofran, GlaxoSmithKline) has been used to prevent chemotherapy-induced nausea and vomiting.
The FDA issued a drug safety communication in June urging clinicians to stop using the 32-mg, single IV dose due to the risk for QT interval prolongation. QT interval prolongation can lead to torsades de pointes, a potentially fatal heart rhythm.
Those doses — which are sold pre-mixed in solutions of either sodium chloride or dextrose — will be removed from the market through the early part of 2013, according to an FDA press release.
The FDA has not recommended an alternative single IV dose regimen. Instead, the agency recommends the IV regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral dosing continues to be effective, according to the press release.
The 32-mg, single IV dose comprises a small percentage of IV ondansetron, so the FDA does not anticipate a drug shortage.
The FDA encourages clinicians and patients to report adverse events or side effects related to the use of these products through the MedWatch Safety Information and Adverse Event Reporting Program. Report forms are available online at www.fda.gov/medwatch/report.htm or by calling 800-332-1088.