Drugs - Qualaquin (quinine)
October 2007
Therapeutic area - Malaria
Patient has uncomplicated Plasmodium falciparum malaria.
In December 2006, the FDA ordered all firms to stop marketing unapproved drug products containing quinine, citing serious safety concerns, including deaths associated with quinine products. Under the FDA order, all manufacturing of unapproved products containing quinine must cease within 60 days. Various preparations that exist include the hydrochloride, dihydrochloride, sulfate, bisulfate, and gluconate. The FDA notes that only one quinine product (Qualaquin®, made by Mutual Pharmaceutical Company, Inc) is currently approved by the FDA; although it is indicated only for the treatment of uncomplicated Plasmodium falciparum malaria. Use of quinine to treat leg cramps, is an unapproved, and unsupported indication.
Quinine is a drug with a narrow margin between an effective dose and a toxic dose and is associated with serious drug interactions. Since 1969, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Other concerns include quinine's potential to cause serious side effects, including cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions.
MHCP will cover Qualaquin® only for its FDA approved indication (treatment of uncomplicated Plasmodium falciparum malaria) in the fee-for-service population. No quinine product is covered by MHCP for recipients covered under a Medicare Part D plan.
MHCP Provider Call Center 651-431-2700 or 800-366-5411
