Quinine Attorneys

Recent FDA Actions

On December 11, 2006, The Food and Drug Administration (FDA) ordered firms to stop marketing unapproved drug products containing Quinine, a drug used to treat malaria, citing serious safety concerns, including deaths, associated with Quinine products. There are multiple unapproved products containing Quinine currently marketed. However, there is only one Quinine product approved by the FDA.

As part of its action, FDA is also cautioning consumers about off-label use of Quinine to treat leg cramps. Quinine is approved for treatment of malaria, but is also commonly prescribed to treat leg cramps and similar conditions. Because malaria is life-threatening, the risks associated with Quinine use are justified for that condition. But because of the drug's risks, FDA believes it should not be used to prevent or treat leg cramps.

The action posted in a Federal Register notice is part of FDA's continued efforts against unapproved drug products.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01521.html