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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY December 2012 | Archived Issues

FDA updates regarding Zofran, Chantix

Pharmacy focus

32 mg, single IV dose of Zofran no longer marketed

The 32 mg, single intravenous dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks, according to the U.S. Food and Drug Administration.

This dose of Zofran had been used to prevent chemotherapy-induced nausea and vomiting. A previous FDA announcement 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.

These products likely will be removed from the market through early 2013, according to the FDA. The agency 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

The FDA continues to recommend the intravenous regimen of 0.15 mg/kg administered every four hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral dosing of the drug 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.

Click here to read the complete MedWatch Safety Alert.

Updated safety review on the risk of cardiovascular adverse events with Chantix

The FDA is informing the public about the results of a large, combined analysis, called a meta-analysis, of clinical trials that compared patients who received the smoking-cessation drug Chantix (varenicline) to patients who received a placebo, an inactive treatment. A higher occurrence of major adverse cardiovascular events – a combined outcome of cardiovascular-related death, nonfatal heart attack and nonfatal stroke – was observed in patients using Chantix compared to those using a placebo. These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.

Healthcare professionals are advised to weigh the risks of Chantix against the benefits of its use. It is important to note that Chantix is effective in helping patients to quit smoking and abstain from it for as long as one year. The health benefits of quitting smoking are immediate and substantial.

Click here to read the MedWatch alert, including links to the FDA Drug Safety Communication.