Over a year ago, on April 7, 2005, the FDA asked manufacturers of OTC NSAIDs to revise their labeling to include more specific information to assist consumers in the safe use of the drugs.
"This includes," the FDA said, "instructions about which patients should seek the advice of a physician before using these drugs, stronger reminders about limiting the dose and duration of treatment in accordance with the package instructions unless otherwise advised by a physician, and a warning about potential skin reactions."
In the new labeling, the FDA instructed manufacturers to include: (1) more specific information about the potential CV and GI risks; (2) instructions about which patients should seek the advice of a physician before using these drugs; (3) stronger reminders about limiting the dose and duration of treatment in accordance with the package instructions unless otherwise advised by a physician; and (4) a warning about potential skin reactions.
Although experts are now saying to cut back on NSAIDs, on June 14, 2006, Wyeth began hawking its new product, Advil PM, promoting its use to battle sleeplessness "a few nights a week or more."
According to the company's press release, a survey conducted by the National Sleep Foundation found that almost 20% of Americans (42 million) experienced nighttime pain or physical discomfort that disrupted their sleep a few nights a week or more. In fact, it said, 68% of Americans currently are getting less than eight hours of sleep on weeknights, while the US Department of Health and Human Services recommends at least eight hours of uninterrupted sleep.
The profits up for grabs are as always obscene. According to Wyeth, 15% of Americans are turning to sleep aids, making the sleep aid market a $3.1 billion business annually in the US, of which more than $260 million can be attributed to OTC drugs.
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/advil_motrin.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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