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FDA Warns of Risks With Unapproved Use of Quinine Sulfate ROCKVILLE, Md -- July 8, 2010 -- The US Food and Drug Administration (FDA) today warned that the unapproved use of the malaria drug quinine sulfate (Qualaquin) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating healthcare professionals and patients about the potential risks. Quinine is not FDA-approved to treat or prevent night time leg cramps. A review of reports submitted to the FDA's Adverse Event Reporting System (AERS) between April 2005 and October 1, 2008, found 38 US cases of serious side effects associated with the use of quinine. Quinine use resulted in serious and life-threatening reactions in 24 cases, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura. In some patients, these side effects resulted in permanent kidney impairment and hospitalisation. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome. The risk management plan, called a Risk Evaluation and Mitigation Strategy (REMS), requires that patients be given a Medication Guide explaining what quinine is and is not approved for, as well as the potential side effects of the drug. The company is also required to issue a Dear Health Care Provider Letter warning of the potential risk of serious and life-threatening haematologic reactions. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version