FDA Removes Unapproved Quinine Drugs From Market

Yael Waknine


December 13, 2006

December 13, 2006 — The US Food and Drug Administration (FDA) has ordered the removal of unapproved drug products containing quinine, citing serious safety concerns and deaths associated with their use. The action is part of a larger effort to remove all unsafe, unapproved drugs from the market.

Since 1969, the FDA received 665 reports of serious adverse events (including 93 fatalities) associated with quinine use, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Serious adverse events have included cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs can also occur.

The FDA notes that only one quinine product ( Qualaquin, made by Mutual Pharmaceutical Company, Inc) is currently approved by the FDA. Although indicated only for the treatment of uncomplicated Plasmodium falciparum malaria, the drug is often prescribed to treat leg cramps and similar conditions despite drug label warnings advising that the risks associated with its use in this setting outweigh potential benefits.

Unapproved quinine drug products are marketed without these drug label warnings, which increases the risk for their misuse and potential consumption of doses that have not been reviewed or approved by the FDA. Because of its narrow therapeutic index, quinine must be used carefully; dose modifications and/or close monitoring may be required for patients with hepatic or renal impairment.

Under the FDA order, all manufacturing of these products must cease within 60 days. However, some previously shipped merchandise may remain on pharmacy shelves for a short time. Consumers have been advised to contact their healthcare provider with any questions or concerns regarding their use of unapproved quinine products.

Adverse events potentially related to quinine therapy should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.