Danger in Products Containing Quinine (March 2007)
December 302009
FDA has told manufacturers to stop marketing unapproved drug products containing quinine because of serious safety concerns. There are many of these products presently on the market. While quinine has traditionally been used as a treatment for malaria, many patients use these products to treat leg cramps and similar conditions, a use which is not approved by FDA.
FDA has received 665 reports of serious adverse events associated with quinine use since 1969, including 93 deaths. Among the side effects of quinine are cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions.
Because of these serious side effects, and because the toxic dose for quinine is only slightly higher than the therapeutic dose, patients should be warned against treating their leg cramps with quinine products.
At the present time, Qualaquin, manufactured by Mutual Pharmaceutical Company, is the only quinine product approved by the FDA. Qualaquin is indicated for the treatment of malaria, and its labeling specifically warns that the product is not indicated for treating leg cramps.
Additional Information:
FDA Medwatch Safety Alert. Quinine products. December 12, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Quinine
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