Gallup, NM (PRWEB) May 3, 2006
Roche Holding AG's prescription diet drug Xenical should immediately be pulled from the US market after recent data linked it to pre-cancerous colon lesions in animal studies, a consumer group told federal health regulators on Monday.
Public Citizen, in a petition, also asked the US Food and Drug Administration to reject making the weight-loss pill widely available over the counter. On Friday, the FDA said it granted GlaxoSmithKline Plc conditional approval to sell the drug without a prescription if it first meets certain undisclosed criteria. Glaxo owns US rights for non-prescription sales of Xenical."The failure to ban the prescription version of this drug, or worse, to make it much more widely available by allowing OTC sales is a decision that is likely to increase cancer incidence," Public Citizen wrote.
The group said a December 2005 study confirmed earlier company data showing Xenical, known generically as orlistat, can cause abnormal cell growth in the lining of the colon. Experts widely recognize the lesions as an early indicator of cancer, the advocacy group added.
The study, published in the journal Cancer Letters, found "a significant increase" of colon lesions in rats given Xenical regardless of whether they were on high-fat or standard diets. "This finding makes it even clearer how ill-advised switching orlistat to OTC status would be," the petition said.
Public Citizen also said its review of reported side effects after Xenical hit the market in 1999 found 28 cases of breast cancer in patients taking Xenical through June 2005.
A review of its rival, Abbott Laboratories Inc.'s appetite suppressant Meridia, found two breast cancer cases between November 1997 and June 2005.
The FDA was aware of the breast cancer risk as well as possible colon lesions when it initially considered Xenical, Public Citizen said, but the agency chose to rely on the company's analysis.
"Over the past decade I have had a front-row seat to the obesity epidemic in America. In counselling patients in my practice, I find that patients as health care consumers are frustrated by diet plans and drugs that offer short-term results but fail to deliver lasting change and many bounce from plan to plan and physician to physician seeking lasting solutions to the problem of obesity. This most recent incident with Xenical simply underscores the fact that safe, long- term, effective weight loss, the holy grail for consumers, requires more than just a pill," says Dr. Ouida Vincent
Dr. John Abramson in his book "Overdosed America" writes, "obesity is primarily a social disease--the result of aggressive marketing of high calorie foods and our physically inactive culture--in much the same way that tuberculosis was primarily a social disease of the nineteenth century, the result of overcrowding and the uncontrolled ravages of the industrial revolution. Clearly, the outlook for Americans' health is not good when one of the key risk factors for most chronic diseases is increasing at an epidemic pace and little is being done to get at the heart of the problem."
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