New FDA warnings for quinine, commonly used drug for leg cramps

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If you’re taking the malaria drug quinine (Qualaquin) for nighttime leg cramps, you should stop because you could be risking serious and life-threatening side effects. That’s according to a new warning this week from the Food and Drug Administration, which said it has received dozens of reports of people who developed severe adverse effects while taking the drug, including permanent kidney impairment and two deaths.

Qualaquin is only approved for treating malaria, so treating nighttime leg cramps or restless leg syndrome is an unapproved–and potentially dangerous–use of the drug. This unapproved use has been a problem that has persisted for decades, despite numerous warnings from the FDA and little evidence that the drug helps relieve the leg cramps.

The FDA said in its announcement that it received 38 reports of people suffering serious side effects from Qualaquin between April 2005 and October 1 2008. Twenty-four of these were life-threatening, and most of these occurred in people taking the drug to treat leg cramps or restless leg syndrome. The serious problems included a blood disorder (hemolytic uremic syndrome/thrombotic thrombocytopenic purpura) that causes blood clots and can lead to kidney impairment. Some people developed permanent kidney impairment and had to be hospitalized, and two died.

The FDA said the manufacturer of Qualaquin was developing a risk management plan to help communicate these potential risks to physicians and consumers.

Read on for more details about the risks of taking quinine.  

Steve Mitchell, associate editor, Consumer Reports Health Best Buy Drugs 

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