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2006/04/12, 02:29 PM
I don't know a whole lot about this obesity drug. But I can see that if this goes over-the-counter, there will be people everywhere abusing this stuff. What do you think?
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Petition seeks to stop Xenical from going OTC
2006 April 11
By Rita Rubin
The consumer advocacy organization Public Citizen petitioned the Food and Drug Administration on Monday to pull Xenical, a prescription drug used to treat obesity, from the market.
Xenical keeps about 30% of dietary fat from being absorbed by the intestine. It's designed for obese people (those who are at least 30 pounds overweight) or those who have less to lose but have health risks such as diabetes or high cholesterol.
On Friday, maker GlaxoSmithKline said it had learned that the FDA would approve over-the-counter Xenical, to be called Alli, once the company answered some remaining questions. If approved, the medication would be the first prescription obesity drug to go OTC.
Glaxo says it plans to market Alli as part of an overall diet and exercise program. The label would advise consumers not to take it for more than six months at a time.
Public Citizen's petition argues that the risks associated with Xenical outweigh its limited benefit. The petition, addressed to acting FDA administrator Andrew Von Eschenbach, makes the following points:
*Research on animals -- some of it conducted by the drug's manufacturer -- shows that orlistat, the chemical name for Xenical, increases the number of a type of abnormal colon cell that is believed to be a precursor to cancer.
*The FDA delayed approving orlistat in the late 1990s because of concerns that it might increase breast cancer risk, but the label does not mention that possibility.
*Because orlistat blocks fat absorption, it can cause unpleasant bowel symptoms such as fecal incontinence and can prevent fat-soluble vitamins, namely beta carotene and A, D, E and K, from being absorbed by the body.
*Recently published clinical trials found that, after four years, patients who took orlistat lost only about 3% more of their body weight than patients who took a placebo.
In January, an FDA advisory panel voted 11-3 in favor of OTC orlistat. Glaxo spokeswoman Malesia Dunn declined Monday to reveal the nature of the FDA's remaining questions.
In recent years, the FDA has banned phenylpropanolamine, or PPA, and ephedra, the two main ingredients in over-the-counter weight-loss products.
With OTC orlistat, "Glaxo is seeking to make a fortune,'' says Sidney Wolfe, director of the Public Citizen Health Research Group.
Wolfe's co-signers on the petition include Thomas and Theresa Pretlow, husband-and-wife researchers at Case Western Reserve University School of Medicine, who have published numerous scientific papers about the abnormal colon cells linked to orlistat.
In 2002, Public Citizen petitioned the FDA to pull Meridia, another prescription obesity drug, from the market because it increased the risk of heart problems while providing minimal benefit. The FDA rejected the petition two years later.
Glaxo spokeswoman Dunn did not comment about Public Citizen's petition to stop Xenical.
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--JBennett
"I've up-ed my intensity.... now up yours!"
"Pain is only weakness leaving the body."
"Never think of how weak you are; think of how strong you're going to be."
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