New REMS for quinine

New REMS for quinine

The FDA banned the OTC use of quinine sulfate for the treatment of nocturnal leg cramps in 1994 after receiving more than 150 reports of adverse reactions, including 23 deaths. Quinine sulfate (brand name Qualaquin^®) remains the only quinine product on the market, but is approved only for the treatment of uncomplicated malaria caused by Plasmodium falciparum. Qualaquin, however, is much more commonly used off-label for nighttime leg cramps. The FDA continues to get reports of life-threatening hematologic reactions associated with quinine sulfate including thrombocytopenia, hemolytic-uremic syndrome/TTP, hearing loss, and cardiovascular problems. Between 2005 and 2008 there were 38 cases of serious side effects including 2 deaths. The FDA has announced a new Risk Evaluation and Medication Strategy (REMS) for Qualaquin that will include a Medication Guide explaining what the medication is and is not approved for, as well as the potential side effects of the drug. The medication guide specifically states that "Qualaquin should not be used for nighttime leg cramps," and those using it for this indication are at risk of serious side effects (FDA Drug Safety Communication, July 8, 2010).