FDA Warning: Qualaquin Unapproved For Use For Night Leg Cramps Due to Serious Side Effects

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The FDA issued a warning this week due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, it states in part as follows "FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for 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.

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