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July 13, 2010: FDA Risk Management Plan Regarding Qualaquin

FDA released a statement on July 8, 2010 regarding Qualaquin (quinine sulfate) and the risk of serious hematological reactions . Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA approved a risk management plan to warn against the use of this drug for such unapproved uses.

The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS  requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.

Qualaquin is the only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum. Most users are travelers returning from malaria-endemic areas, but the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps.

The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.

FDA says that Qualaquin should not be used for night time leg cramps because 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.

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