FDA Cracks Down on Unapproved Quinine Drugs and Use of Quinine for Leg Cramps

Citing safety concerns, the FDA yesterday ordered several companies to stop marketing unapproved quinine-containing drugs. The agency also warned against the use of quinine to treat leg cramps.

To date, the FDA has approved only one quinine product, Qualaquin, and the drug is approved only for the treatment of malaria. Though quinine is frequently prescribed for leg cramps, the labeling on Qualaquin states that the associated risks -- including cardiac arrhythmia, thrombocytopenia, severe hypersensitivity reaction, and death -- outweigh "any potential benefit in treating and/or preventing this benign, self-limiting condition."

Manufacturing of unapproved quinine products, many of which are marketed without such warning information, must cease within 2 months, according to the FDA announcement. Previously manufactured products may continue to be available at pharmacies for a short period.