Pharmacy Services
Quinine Sulfate - FDA Orders Halt of the Sale of Unapproved Products
December 13, 2006
The FDA issued a MedWatch alert informing healthcare professionals about the agency’s order to stop marketing unapproved quinine products. The only approved quinine sulfate product available is a 324 mg capsule from Mutual Pharmaceuticals. All other quinine sulfate products are unapproved and firms must stop selling them within 60 days.
Quinine can cause serious side effects such as cardiac arrhythmias, severe hypersensitivity reactions, and thrombocytopenia. Quinine sulfate is most frequently used off-label to treat leg cramps. The FDA has received 665 reports of adverse events including 93 deaths associated with quinine use. Mutual’s quinine sulfate was approved August 2005 for the treatment of falciparum malaria. The labeling specifically states this product is not approved for nocturnal leg cramps.
Additional information is available at the following links:
- MedWatch Safety Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150746.htm - Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108799.htm - Prescribing Information for Mutual’s Quinine Sulfate:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf - ASHP News Story:
http://www.ashp.org/import/News/HealthSystemPharmacyNews/newsarticle.aspx?id=2385
Updated
December 13, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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