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FDA May Approve OTC Fat-Blocking Pill

25 Jan, 2006 Response This Week

WASHINGTON- The direct response marketing industry has been offering a variety of fat-trappers, burners and repellants for several years, often being cited by the U.S. governmental agencies for making untrue or unsubstantiated claims. Yet, the U.S. Food and Drug Administration (FDA) announced Monday that it may for the first time approve an over-the-counter (OTC) fat-blocker pill.

In 1999, Orlistat, marketed as Xenical, was FDA-approved to be sold by prescription only, but now pharmaceuticals giant GlaxoSmithKline (GSK) is hoping to win permission to sell an OTC version. In 2004, GSK was granted exclusive rights to market the product if the FDA gave the green light. It would be the first OTC non-prescription weight-loss drug to hit the market and would cost between $12 and $25 per week, according to GSK.

In a 2004 company release, Jack Ziegler, president of GSK Consumer Healthcare said, “We are very pleased that Roche has selected GSK to market OTC Orlistat in the U.S. Orlistat is a unique, clinically proven medicine that helps committed people lose weight. Orlistat works by preventing some of the fat consumed in food from being absorbed.”

GSK’s OTC version would be called Alli and would contain half the dose of the prescription drug.

Although GSK’s senior vice president of research and development John Dent said that there is no “magic pill,” he told the Associated Press that, “Orlistat is a tool that will help people control their calorie intake and modify their diet.”

Orlistat is said to block one-quarter of fat consumed. The FDA deemed the products “safe and effective” in earlier reports, but according to Dr. Julie Golden, a medical officer in the FDA’s metabolism and endocrinology products division, patients who discontinued the drug experienced progressive weight gain.

One of the main side effects that could deter the FDA from approving OTC distribution is the drug’s potential to deplete the body of essential vitamins, especially the fat-soluble vitamins beta-carotene, D, E and K. This side effect could be avoided simply by taking a multi-vitamin supplement. However, in trial studies, the FDA reported that 47 percent of the participants did not take the supplements.

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