FDA Advances Effort Against Marketed Unapproved Drugs
FDA Orders Unapproved Quinine Drugs from the Market and Cautions Consumers About “Off-Label” Use of Quinine to Treat Leg Cramps
December 11, 2006
The Food and Drug Administration (FDA) today 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. …
… One quinine drug product, 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.
Since 1969, FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems), and severe hypersensitivity reactions. There is also the potential for serious interactions between quinine drugs and other drugs, and there are conditions under which quinine should not be used.
Under today’s action, previously manufactured unapproved products may still be found on pharmacy shelves for a short period of time, but manufacturing of new product must cease in 60 days. …[RIGHT]CITE[/RIGHT]