Originally published February 23 2006
Weight loss drug Orlistat receives FDA recommendation but medical officers have some reservations
by Mike Adams, the Health Ranger, NaturalNews Editor
Dr. Julie Golden, an FDA officer in the division of metabolism and endocrinology products, speaks about the limits of orlistat's effectiveness, as most patients who stop taking the drug quickly regain the weight they lost.
A pharmaceutical company hopes to begin selling this year a fat-blocking pill directly to millions of overweight Americans who now only have access to a prescription version of the drug.
The Food and Drug Administration could approve over-the-counter sales of orlistat in the next few months, said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.
If orlistat wins a nonprescription OK, it would become the first such weight-loss pill to win the FDA's sanction.
An FDA advisory panel voted 11-3 late Monday to recommend that the regulatory agency approve the nonprescription form of orlistat, which Glaxo would market as Alli (pronounced "ally").
The agency is not bound by the recommendation but usually follows the advice of its expert panels.
"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," Quesnelle said.
That fat _ about 150 to 200 calories' worth _ is passed out of the body in stools, which can be loose as a result.
Glaxo officials cautioned that orlistat is no magic pill: In six-month clinical trials, obese people who took the pills lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills.
"Orlistat is a tool that will help people control their calorie intake and modify their diet," said John Dent, the pharmaceutical company's senior vice president of research and development.
"Have you considered placing a warning on the box, 'Don't take this product while wearing your new La Perla underwear?'" panel chairman Dr. Alastair Wood, referring to the Italian brand of lingerie, asked company executives.
Discussion of the side effects recalled the hubbub that surrounded the FDA's approval in 1996 of the fat substitute Olestra, which also caused diarrhea and spotting.
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