Drugs

FDA Drug Safety Podcast: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products

Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s Topic: Updated information on the 32 mg intravenous ondansetron dose and pre-mixed ondansetron products.

US Public Health Service Lieutenant Commander Stephanie Begansky, a pharmacist in the division, will provide you with additional information about this communication.

LCDR Begansky: On December 4, 2012, the FDA issued a Drug Safety Communication notifying health care professionals that the 32 mg, single intravenous dose of the anti-nausea drug Zofran, active ingredient ondansetron hydrochloride, will no longer be marketed because of the potential for serious cardiac risks. This dose has been removed from the Zofran drug label. FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.

A previous Drug Safety Communication, issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.

The 32 mg, single IV dose had been used to prevent chemotherapy-induced nausea and vomiting. As stated in the previous Drug Safety Communication, FDA continues to recommend the IV regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. If the calculated weight-based dose were to exceed 16 mg, the potential for prolonged QT interval would be greater; therefore, no single intravenous dose should exceed 16 mg. In addition, oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting. At this time, there is not enough information available for FDA to recommend an alternative single IV dose regimen.

FDA anticipates these products to be removed from the market through early 2013. FDA does not anticipate that removal of the 32 mg intravenous dose of ondansetron currently sold as pre-mixed injections will contribute to a drug shortage of IV ondansetron, as the 32 mg dose makes up a very small percentage of the current market. According to sales distribution data, ondansetron IV 32 mg premixed bags accounted for less than 1% of ondansetron IV sales (vials, bags, etc.) from the manufacturers to retail and non-retail channels of distribution in the 12-month period ending in June 2012.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication which includes a list of ondansetron products to be voluntarily withdrawn from the U.S. market can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.