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Non-Prescription Xenical: Adults Only

January 20, 2006

Are you old enough to lose weight? Xenical (orlistat) manufacturer GlaxoSmithKline wants to produce a non-prescription strength version of the popular diet drug, according to a report published by the Seattle Post-Intelligencer on January 14.

But restrictions may apply-buyers must prove they are not underage. Limiting sales to people of legal age would alleviate the government's concerns that adolescents might buy and then misuse the drug.

The proposal to sell a lower-strength version of Xenical is aptly timed-not only is the US dealing with a rapidly growing obesity epidemic, but obesity-associated illness, such as diabetes, is also on the risk and placing increasing burdens on the healthcare system.

Xenical has proven to be an extremely popular weight-loss drug, both because of its effectiveness for many people and because of its strong safety profile. It is the only prescription weight-loss drug whose active ingredient (orlistat) does not act systemically, but rather exerts its pharmacologic effects inside the digestive tract.

Several clinical trials have demonstrated Xenical's efficacy, including one trial led by a University of Kentucky professor that showed orlistat helped overweight patients lose 5% of their baseline weight within just four months. This weight loss equates with the same weight loss obese people achieve over a two-year period by controlling food portion sizes in a federal study, according to the Seattle Post-Intelligencer report.

While a GlaxoSmithKline spokesperson reportedly said that they company has not been formally asked to present a plan to contravene misuse of the drug by teenagers, if it is sold without a prescription, they did confirm that they will have a plan ready for US Food and Drug Administration (FDA) advisors when they discuss their plan on January 23.

"We don't know if this is going to be a requirement," said Brian Jones, a Glaxo spokesperson, according to the Seattle Post-Intelligencer. "If we do have to do it, we intend to have our preparations in place."

The FDA's Concerns

The FDA's main concern is whether young people would misuse lower-dose orlistat in the same way that they misuse laxatives and other diet-pills.

Statistics concerning diet-pill use among adolescents are alarming. According to the Centers for Disease Control and Prevention (CDC), a total of 7.3% of Massachusetts high school students took diet remedies without consulting a physician in 2003 (the most current figures available). Moreover, 6.1% said they induced vomiting or used laxatives to lose weight or to avoid weight-gain.

"There is a potential for misuse," said Dr David Katz, director of the Prevention Research Center at the Yale University School of Medicine, to the Seattle Post-Intelligencer. He also noted that the students who are most likely to misuse diet-pills include young women with eating disorders and sportsmen and sportswomen eager to control their weight.

One advantage orlistat may have against misuse is that it does not create the high that some diet-pills can when taken at higher doses, said Dr James Anderson, a University of Kentucky professor of medicine who recently conducted a Xenical clinical trial. Another deterrent against misuse is that orlistat can trigger an embarrassing and sudden loss of bowel control.

To monitor purchases, stores are unlikely to use a single approach. However, Glaxo's Jones outlined one potential strategy: When the cashier rings up a Xenical sale at the register, a computer-prompt could require them to request proof of age, and until a valid birthdate is entered, the sale cannot be completed.

Weight-loss drug may be sold to adults only, Seattle Post-Intelligencer, January 14, 2006.

Posted: January 2006