FDA warns against using the malaria drug Qualaquin for leg cramps

Every once in a while I am shocked awake by a bad leg cramp that forces me out of bed in an effort to ease the pain. For me it’s a rare event, but millions of people suffer from nighttime leg cramps and what is known as restless leg syndrome.

Many of them take the malaria drug Qualaquin for relief - despite clear warning that its “use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening” blood and kidney problems.


The prescription drug’s label also states that “the risk associated with QUALAQUIN use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit.”

Still, people are using the drug, which is distributed by AR Scientific Inc. and made by affiliated Mutual Pharmaceutical Co., both located in Philadelphia.

The Food and Drug Administration has been getting reports of side effects in people using the medication to prevent or treat restless leg syndrome and nighttime leg cramps despite the warnings. Most of the 38 most serious incidents reported to the FDA, including two deaths, involved blood problems, some of which resulted in permanent kidney damage.

The use of Qualaquin for leg cramps has never been approved in the U.S., although some doctors continue to prescribe it. Now the FDA is warning consumers that they should use it only for uncomplicated malaria – in fact, the only use for which the drug has ever been approved in this country.

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