FDA Takes Action Against Unapproved Quinine Drugs

December 15, 2006
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Dec. 12)-Citing serious safety concerns, the US Food and Drug Administration is ordering unapproved quinine drugs from the market, including those containing quinine sulfate and any quinine salt.

Rockville, MD (Dec. 12)-Citing serious safety concerns, the US Food and Drug Administration (www.fda.gov) is ordering unapproved quinine drugs from the market, including those containing quinine sulfate and any quinine salt. Only one quinine product, which received orphan drug designation and was developed by Mutual Pharmaceutical Company, (Philadelphia, PA, www.urlmutual.com), has been granted FDA approval as a treatment for malaria, but several unapproved quinine products are marketed and prescribed as off-label therapies for treating leg cramps and other similar conditions.

In March 1998, FDA concluded that, because of safety issues, over the counter products containing quinine and quinine salts were not generally regarded as safe and, therefore, defined them as new drugs according to the Federal Food Drug and Cosmetic Act section 201[p]. In its docket (www.fda.gov/OHRMS/DOCKETS/98fr/06n-0476-n000001.pdf) the agency states that it has received 665 reports of serious adverse events associated with quinine use, including 93 deaths since 1969 through September 2006. The unapproved products generally do not contain the warnings on their labeling that are found on that of the approved product.

FDA warns manufacturers that “manufacturing or shipping unapproved quinine products can result in seizure, injunction, or other judicial proceeding.” Moreover, the agency has stated that it does not expect to issue warning letters or other warnings to companies that market unapproved quinine-containing products before taking “enforcement action.”