-December 13, 2006
Makers of unapproved drugs containing quinine have been ordered to stop marketing the potentially dangerous products, the Food and Drug Administration said in a statement released Monday.
Only one quinine drug product is FDA approved. That drug, Qualaquin, is used in the treatment of malaria, which is a life-threatening illness. The labeling for the malaria drug warns of the risks associated with quinine, including:
- Potentially serious drug interactions
- Cardiac arrhythmia
- Severe hypersensitivity reactions
- Decrease in blood platelets, which can cause hemorrhage or clotting problems
Despite these risks, unapproved quinine-containing drugs are commonly prescribed for off-label uses such as treating leg cramps. According to the FDA, however, using quinine drugs to treat leg cramps and similar conditions poses unnecessary health threats.
We believe unapproved quinine products represent a serious health risk because of the widespread use of this product for treating leg cramps. Quinine needs to be dosed carefully, and FDA-approved labeling reflects the fact that the risks associated with the use of this drug for the treatment of leg cramps outweigh the benefits, said Dr. Steven Galson, Director of the FDA’s Center for Drug Evaluation and Research.
The FDA is requiring the manufacture of unapproved quinine drugs to cease within 60 days. Quinine-containing products already on the shelves will be permitted to remain on the market for a brief time.
Consumers are urged to contact their healthcare provider with any questions or concerns related to the use of quinine drugs.
Since 1969, quinine drugs have been linked to 665 serious adverse events, 93 of which resulted in death.
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