FDA Removes Unapproved Quinine Drugs From the Market

Citing a range of severe adverse effects, the U.S. Food and Drug Administration (FDA) has called for the removal of unapproved quinine drugs from the market. Currently only one quinine drug has been approved by the FDA–for the treatment of malaria–but quinine drugs are often prescribed “off-label” for the treatment of leg cramps. The FDA issued a stern warning to consumers that quinine drugs are potentially dangerous and should not be used to treat leg cramps.

“Because malaria is life-threatening, the risks associated with quinine use are justified for that condition,” reads the FDA’s statement. “But because of the drug’s risks, FDA believes it should not be used to prevent or treat leg cramps.”

The agency said the move is part of a larger effort to remove all unsafe, unapproved drugs from the marketplace. “Providing the American public with safe and effective medical products is our core mission,” said Dr. Andrew von Eschenbach, Acting FDA Commissioner. “The presence of unapproved drugs on the U.S. market is in stark contrast to our current approach to drug safety because those drugs may not meet modern standards for safety, effectiveness, quality, and labeling. As part of our drug safety efforts, we are committed to ensuring all marketed drugs have required FDA approval.”

According to the statement: “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.”

The FDA has ordered all manufacturing of unapproved quinine products to end within 60 days, although they note that some products may remain on store shelves for a period of time. In the last 35 or so years, the FDA has received hundreds of reports of serious adverse events associated with quinine use, including 93 deaths. Potential side effects include cardiac arrhythmias, thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems), and severe hypersensitivity reactions. There have also been reports of severe negative interactions between quinine drugs and other drugs.

“This summer, when the agency began its aggressive efforts to remove unapproved drugs from the market, we vowed to target the products with the most serious public health risks,” said Dr. Steven Galson, Director of the FDA’s Center for Drug Evaluation and Research (CDER). “We believe unapproved quinine products represent a serious health risk because of the widespread use of this product for treating leg cramps. Quinine needs to be dosed carefully, and FDA-approved labeling reflects the fact that the risks associated with the use of this drug for treatment of leg cramps outweigh the benefits.”