FDA approves Risk Evaluation and Mitigation Strategy (REMS) for Qualaquin

The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for Qualaquin (quinine sulfate capsules, from AR Scientific) to warn against “off-label” uses. Such unapproved uses include the treatment of night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.

The 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. Healthcare professionals should 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.

Qualaquin is approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218424.htm.