FDA Warns of Risk with Unapproved Use of Malaria Drug Qualaquin

The Lyon Firm is investigating cases related to the unapproved use of Qualaquin. Qualaquin is marketed by Philadelphia based AR Scientific. The FDA approved Qualaquin in August 2005 for treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, a life threatening infection if left untreated.

The Lyon Firm is investigating cases related to the unapproved use of Qualaquin. Qualaquin is makrket by Philadelphia based AR Scientific. The FDA approved Qualaquin in August 2005 for treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, a life threatening infection if left untreated.

However, Qualaquin has been prescribed to treat night time leg cramps or “restless leg syndrome”. Qualaquin is not approved for this use. The FDA reported that it had received numerous reports of adverse events when used to treat “restless leg syndrome”. These events included thrombocytopenia, hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura. Some patients experienced permanent kidney impairment.

Health professionals and patients are advised to report any serious adverse events to the FDA’s Medwatch program.