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FDA approves REMS for quinine sulfate
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The FDA recently approved a Risk Evaluation and Mitigation Strategy to warn against the use of quinine sulfate for the off-label treatment of nocturnal leg cramps.
According to an FDA safety warning, the use of quinine sulfate (Qualaquin, AR Scientific) may result in serious and life-threatening hematologic reactions, including bleeding due to thrombocytopenia, and thrombotic thrombocytopenic purpura, which may result in permanent kidney damage.
A review of reports submitted to the FDA’s Adverse Event Reporting System between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious adverse events associated with the use of quinine sulfate.
“Health care professionals and patients should be aware that [the] FDA has not approved the use of [quinine sulfate] for the treatment or prevention of nighttime leg cramps,” said Edward Cox, MD, MPH, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The drug is currently the only FDA-approved treatment for uncomplicated malaria cause by Plasmodium falciparum. According to the safety warning, most of quinine sulfate’s use in the United States is for the treatment and prevention of nocturnal cramps. However, the product label states that the risk associated with the use of quinine sulfate in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweighs any potential benefits.
The Risk Evaluation and Mitigation Strategy (REMS) requires that patients be given a medication guide explaining what this medication is and is not approved for, as well as the potential adverse events of this drug. In addition, the REMS requires that the manufacturer issue a “Dear Health Care Provider” letter warning of the risk for serious and life-threatening hematologic reactions.
The FDA highlighted this information for health care professionals:
- Quinine is only approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum.
- Quinine is not approved for the treatment or prevention of nighttime leg cramps. Prescribing quinine for this condition exposes patients to risk for serious adverse events.
- Discuss with patients the warning signs of thrombocytopenia such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown or red spots on the skin.
- Encourage patients to read the medication guide given to them at the pharmacy before starting quinine and each time they get a refill.
- Report adverse events to the FDA MedWatch program.