SILVER SPRING, Md. Unapproved use of a drug used to treat malaria can cause serious side effects, prompting the drug’s manufacturer to develop a risk management plan, the Food and Drug Administration said.
The FDA said that use of Philadelphia-based AR Scientific’s drug Qualaquin (quinine sulfate) to treat nighttime leg cramps had caused serious and life-threatening bad reactions in 24 patients, including permanent kidney damage and two deaths, as well as reduction in blood platelet levels and internal blood clots.
The reports have prompted AR Scientific to develop a risk evaluation and mitigation strategy, or REMS, requiring that patients receiving Qualaquin be given a medication guide explaining how to use the drug and potential side effects.
“Healthcare professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of nighttime leg cramps,” FDA Center for Drug Evaluation and Research Office of Antimicrobial Products director Edward Cox said. “FDA has received reports that some patients have developed serious side effects when taking quinine for nighttime leg cramps.”