Health
FDA issues cautions on quinine use
NEWS IN BRIEF — Posted Jan. 1, 2007
The Food and Drug Administration ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria. The agency cited serious safety concerns, including deaths associated with unapproved products. Only one quinine drug is approved.
The FDA is also cautioning physicians and consumers about off-label use of quinine to treat leg cramps, a commonly prescribed use. Because malaria is life-threatening, the risks associated with the drug's use are justified, said the agency. That is not the case with leg cramps.
Since 1969, the FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Among the side effects are cardiac arrhythmias, thrombocytopenia and interactions with other drugs.
This effort is part of a larger campaign begun in June of last year by the FDA to remove unapproved drugs from the market.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/01/01/hlbf0101.htm.
