FDA Monitoring More Than 20 Drugs For Potential Risks
Posted on: Friday, 5 June 2009, 13:51 CDT
The US Food and Drug Administration on Thursday released a list of a variety of drugs that it is currently testing for possible safety issues.
The list contains two-dozen different drugs, which vary from treatment of sleep disorder to weight-loss.
Pfizer Inc’s Chantix, a drug aimed at helping people stop smoking, is among the drug varieties currently being monitored by the FDA. Regulators are seeking to determine whether or not the drug poses a possible risk of accidental injury or vision impairment to patients.
"As with all our medicines, we work with the FDA to ensure our labeling reflects the latest safety information," said Sally Beatty, a spokeswoman for Pfizer.
Investigations into the side effects of Chantix began in 2007, following reports of psychiatric problems, including suicidal thoughts, according to the Associated Press. A nonprofit group reported 1,001 cases of blackouts and accidental injuries from patients taking Chantix.
The smoking cessation drug has been banned by the Federal Aviation Administration for use among pilots and air traffic controllers.
Chantix was first approved in May 2006.
Pfizer’s bladder control drug Detrol is also on the FDA’s list due to reports of Stevens-Johnson syndrome, a serious skin reaction.
Weight-loss drugs Xenical and the over-the-counter drug Alli are also being monitored by the FDA for reports of liver toxicity.
Terry Hurley, spokesman for Roche, maker of Xenical, said that available data "does not suggest that orlistat is causally related" to liver problems.
Cephalon Inc’s sleep disorder drugs Nuvigil and Provigil are also on the list of monitored drugs due to reports of serious skin reactions which began in 2007.
The new list released on Thursday includes reports of complications with certain drugs from October through December 2008.
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Source: redOrbit Staff & Wire Reports
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