FDA Warns Manufacturers about Unapproved Drugs Containing Quinine

PharmaManufacturing.com
01/09/2007

On Jan. 8, the U.S. Food and Drug Administration issued the following statement:

FDA has ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria, citing serious safety concerns, including deaths, associated with quinine products. There are multiple unapproved products containing quinine currently marketed. However, there is only one quinine product approved by the FDA. As part of its action, FDA is also cautioning consumers about off-label use of quinine to treat leg cramps. Quinine is approved for treatment of malaria, but is also commonly prescribed to treat leg cramps and similar conditions. Because malaria is life-threatening, the risks associated with quinine use are justified for that condition. But because of the drug’s risks, FDA believes it should not be used to prevent or treat leg cramps.

Mutual Pharmaceutical Company, Inc.’s Qualaquin, is FDA-approved to treat certain types of malaria without complications. Unlike the approved product, many unapproved quinine drug products are marketed without labeling cautioning against use of the product for treatment of leg cramps. The FDA-approved labeling for the product provides extensive warnings regarding serious adverse events associated with use of quinine, potentially serious interactions with other drugs, and conditions under which quinine should not be used. Quinine is a drug with a narrow margin between an effective dose and a toxic dose. The dosing for the approved drug is supported by data to maximize the safety and efficacy of the product. The dosing for the unapproved drugs has not been reviewed and approved by FDA.

In June, 2006, FDA issued a new guidance, "Marketed Unapproved Drugs – Compliance Policy Guide,” which makes clear that firms illegally marketing drugs without FDA approval need to submit applications showing that their products are safe and effective before continuing to market those products. FDA’s actions against unapproved drugs are part of the agency’s broader initiative, launched last year, to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs. Since the FDA announced this initiative, the agency has issued warning letters to several companies that are manufacturing unapproved drugs and federal courts have entered permanent injunctions against two others. FDA expects to further accelerate its enforcement efforts against marketed unapproved drugs in 2007.

To read more about FDA actions against quinine and other unapproved products, visit: www.fda.gov/bbs/topics/NEWS/2006/NEW01521.html or www.fda.gov/cder/drug/unapproved%5Fdrugs/.