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FDA Cautions Against Off-Label Use of Quinine Drugs

Only one product has the agency's approval, and several others on sale have been ordered to cease manufacture

WEDNESDAY, Dec. 13 (HealthDay News) -- The U.S. Food and Drug Administration has ordered several manufacturers of unapproved quinine-containing products to cease manufacture, citing safety concerns. The FDA has also warned consumers about the risks of quinine, used off-label as a treatment for leg cramps.

The only product with FDA approval that contains quinine is Qualaquin, produced by Mutual Pharmaceutical Company, Inc., as a malaria treatment. The product labeling includes warnings about potentially serious adverse effects, drug interactions and circumstances under which quinine should not be prescribed.

The FDA considers the risks of the drug to outweigh the benefits for treating leg cramps. Serious side effects include cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reactions. Since 1969, 665 quinine-related adverse events, including 93 deaths, have been reported to the FDA.

"This summer, when the agency began its aggressive efforts to remove unapproved drugs from the market, we vowed to target the products with the most serious public health risks," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research in Rockville, Md., in a statement.

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