Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued a warning to health care professionals to use extreme caution when prescribing Qualaquin (Quinine Sulfate), according to the Postmarket Reviews section of the Volume 2, Number 2 2, 2009 issue of its quarterly online newsletter, Drug Safety News (DSN).

Qualaquin is approved by the FDA for the treatment of uncomplicated Plasmodium falciparum malaria, a disease rarely found in the U.S. However, drug use data indicates that many prescriptions written for quinine sulfate in the U.S. are for the treatment of nocturnal leg cramps or Restless Leg Syndrome, both of which are off-label uses.

Despite taking regulatory actions to limit the use of the drug for unapproved use, the FDA continues to receive reports of serious adverse events in individuals taking quinine sulfate. From April 2005 through October 1, 2008, 38 cases of severe adverse events with serious outcomes in the U.S. were reported to the FDA’s Adverse Event Reporting System (AERS). The serious outcomes include thrombocytopenia, hypersensitivity reactions and cardiac dysrhythmias. The majority of patients in this case series – 66 percent – took quinine to prevent or treat leg cramps or Restless Leg Syndrome.

In December 2006, the FDA informed manufacturers to stop marketing unapproved prescriptions of quinine products, citing serious safety concerns including deaths. The agency also cautioned consumers about the potential for serious adverse events with serous outcomes if they take quinine for unapproved indications. As a result, only one quinine drug, Qualaqin, remains on the market as an FDA-approved drug, though for other indications.

The FDA encourages health care professionals to only prescribe quinine sulfate for the FDA-approved indication of treating uncomplicated P. falciparum malaria and to seek alternative therapies to nocturnal leg cramps or other musculoskeletal disorders.

Source: FDA

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