其 他 安 全 警 示
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| US FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin (English Only) |
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The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks. Qualaquin is not FDA-approved to treat or prevent night time leg cramps. A review of reports submitted to the FDA’s Adverse Event Reporting System (AERS) between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin. Quinine use resulted in serious and life-threatening reactions in 24 cases, including low level of platelets in the blood (thrombocytopenia), 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. In some patients, these side effects resulted in permanent kidney impairment and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome. Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218383.htm
In Hong Kong: Qualaquin is not registered.
Ends/Friday, July 9, 2010
Issued at HKT 15:00
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