For the second time in five years, public health advocates are seeking to have the Food and Drug Administration prohibit a fat-blocking drug sold over-the-counter and by prescription, noting new reports of kidney stones and pancreatic damage. Since obesity is an epidemic in the U.S., and co-morbid conditions such as obesity can aggravate a workers comp injury, we note significant developments in related products.
According to an Associated Press report, Public Citizen filed a petition with the FDA recently to have the agency remove GlaxoSmithKline's Alli and Roche's Xenical from the market. Alli is sold over-the-counter while Xenical, a greater dose of the drug, is only available through a doctor's prescription. (WCxKit)
According to Public Citizen, it identified 47 instances of acute pancreatitis and 73 kidney stones among patients using the drugs. The reports were gathered from the FDA's public database of negative drug reactions.
Known chemically as orlistat, the drug works by prohibiting the absorption of approximately one-quarter of any fat consumed.
The drug has had its challenges, in part as a result of its unpleasant side effects, including oily, loose stools. Marketing materials for Alli clearly note the importance of maintaining meals under 15 grams of fat to avoid oily stools. Educational pamphlets even advise people begin the program when they have a few days off work, or to bring an extra pair of pants to the office.
Annual sales of Alli have dropped 42% to $84 million in 2010 since its initial unveiling in 2007. Prescriptions of Xenical have fallen to 110,000 last year from 2.6 million in fiscal year 2000, according to data from the FDA and IMS Health.
Last year the FDA added warnings to Xenical and Alli about a few notations of liver damage. (WCxKit)
Public Citizen filed a similar petition to ban the drug five years ago, due to scientific studies tying it to precancerous lesions in rats. That petition only applied to the prescription version Xenical, which has been available in the U.S. dating back to 1999.
Author Robert Elliott, executive vice president, Amaxx Risks Solutions, Inc. has worked successfully for 20 years with many industries to reduce Workers Compensation costs, including airlines, healthcare, printing/publishing, pharmaceuticals, retail, hospitality and manufacturing. See www.LowerWC.com for more information. Contact:[email protected] or 860-553-6604.
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