The Food and Drug Administration (FDA) recently issued a warning about serious side effects caused by the use of the malaria drug Qualaquin, which has also been prescribed to individuals for the treatment of nighttime leg cramps or so-called “restless leg syndrome.” Although potential side effects include severe kidney damage or death, there does not appear to be any wrongful death or products liability cases filed as of yet.
Between April of 2005 and October of 2008, nearly 40 reports of serious side effects were reported to the FDA, with 24 of those cases involving life-threatening reactions. Two individuals have reportedly died due to side effects. In addition to kidney-related problems, the side effects appear to include blood disorders causing blood clots in some and a drop in platelet counts in others.
Although Qualaquin has been approved by the FDA to treat certain types of malaria, it has often been used “off-label” to treat individuals experiencing nighttime leg cramping. Off-label drug use involves doctors prescribing medications for purposes other than what they have been approved for. The practice is both legal and common, but it has come under criticism in recent years as many drugs have been found effective for off-label uses, but have eventually led to unintended and serious side effects.
The marketer of Qualaquin, AR Scientific, has developed a risk management plan to educate doctors and the public about the risks associated with using the drug. The information to be provided to doctors and patients will spell out its approved and unapproved uses as well as warnings about the known side effects.