Pharmacy Daily | New FDA warning

UNAPPROVED usage of the malaria drug Qualaquin (quinine sulfate) is being strongly advised against, after evidence of serious side effects was braught to the US FDA’s attention. According to the FDA the common practice of using Qualaquin for the (unnapproved) treatment of night time leg cramps has led to 38 US cases of serious side effects including low levels of platelets in the blood and hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura - a blood disorder that results in clots in small blood vessels around the body that can be accompanied by kidney impairment. So far, between Apr 2005 and Oct 2008 two people have died from kidney complications arising from unapproved use of Qualaquin. As a result of the FDAs warning, Qualaquin’s manufacturer has had to develop a risk management plan aimed at educating health care professionals and patients about the potential risks. Qualaquin was approved in 2005 for the treatment of uncomplicated malaria.

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