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In Brief: OTC quinine anti-malaria drugs

This article was originally published in The Tan Sheet

Executive Summary

OTC quinine anti-malaria drugs: Quinine-containing OTC drugs for malaria are not generally recognized as safe, FDA states in a final rule published in the March 20 Federal Register. The action confirms the conclusions reached in an agency proposal published in April 1995 ("The Tan Sheet" April 24, 1995, p. 4). The agency in 1994 published a final rule determining that quinine is not safe and effective for use in OTC nocturnal leg cramp products due to a lack of effectiveness data, evidence of quinine toxicity and the potential for serious, life-threatening and fatal hypersensitivity reactions to the substance ("The Tan Sheet" Aug. 22, 1994, p. 8). Because the amount of quinine in anti-malaria products is higher than that in leg cramp products, the agency is concerned that such products present an even greater safety risk. The final rule on OTC malaria products is effective April 20..
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