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news.FDA has warned doctors and patients against unapproved use of the malaria drug Qualaquin (quinine sulfate), to treat night time leg cramps, as it resulted in serious side effects.
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FDA has also prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.
The risk management plan, called a risk evaluation and mitigation strategy (REMS), requires that patients be given a medication guide explaining what Qualaquin is and is not approved for, as well as the potential side effects of the drug.
Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated.
Edward Cox, director of office of antimicrobial products in center for drug evaluation and research at FDA, said: “Health care professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of night time leg cramps.
“FDA has received reports that some patients have developed serious side effects when taking quinine for night time leg cramps.”