FDA News for Health Professionals / U.S. Food and Drug Administration - PDF document

FDA News for Health Professionals / U.S. Food and Drug Administration September 2012 Quinine is FDA-approved for the treatment of uncomplicated malaria. It is not considered safe and ef-fective for the treatment or prevention of leg cramps-- an use. Quinine is associated with thrombocytopenia, Thrombocytopenia associated treatment or prevention of leg cramps includes immune thrombocyto-hemolytic uremic syn-drome thrombotic thrombocyto-associated renal insuffi-Fatalities and renal insufficiency Drug use data from office-based indicate that approximately use is associated with the off-cramps and muscle pain.number of efforts to educate these serious risks. These efforts matologic events associated with FDA and pharmaceutical indus-try communications. Despite these efforts, awareness among prescribers regarding the and the adverse events associated with its use for the treat-ment/prevention of leg cramps There has been a dramatic de- Encuity Resarch, Physician Drug and ars 2008-2011. Data extracted July 2012. for quinine from U.S. outpatient retail pharmacies. In contrast, an estimated 206,000 patients re-tively from 2008 to 2011, general practice/family medi-specialties and internal medicine specialties prescribed the major-clined, the FDA remains concerned because the majority off-label indications relating to leg cramps and muscle pain, and The agency will continue to monitor quinine use and remind the serious risks associated with tion/treatment of nocturnal leg cramps. Janelle Derbis, PharmD, is a member of the Health Professional Liaison Pro-gram in the FDA Office of Special Health Issues. IMS Health, Vector One: Total Pa-tient Tracker. Years 2008-2011. Data extracted July 2012. IMS Health, Vector One: National. Years 2008-2011. Data extracted July 2012. prevent or treat nocturnal leg cramps