FDA: Off-label use of malaria drug tied to side effects

July 23, 2010

The U.S. FDA has approved a REMS to educate practitioners and patients about potential for side effects associated with unapproved treatment quinine for prevention of nocturnal leg cramps.

FDA Drug Safety Communication. July 8, 2010. http://www.fda.gov

The U.S. Food and Drug Administration has approved a Risk Evaluation and Mitigation Strategy (REMS) to educate practitioners and patients about the potential for serious side effects associated with the unapproved treatment quinine (Qualaquin) for the prevention of nocturnal leg cramps. The FDA has approved quinine only for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum; however, the majority of the drug's use in the United States is for the treatment or prevention of nocturnal leg cramps. According to FDA, the use of quinine may result in serious adverse events, including hematological reactions, which could cause permanent kidney damage, hospitalizations, and death.