Orlistat

By ANDREW BRIDGES, Associated Press Writer Tue Jan 24, 9:35 AM ET

WASHINGTON - 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... "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. When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories' worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects, the company said. 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. Once they ceased taking the drug, its effect stopped and they began to regain the weight they had lost, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products.Quesnelle said people could resume use or seek help from a doctor if they gain weight. "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.
A bevy of potentially distasteful and embarrassing side effects struck about half the participants in trials of the drug. Those side effects, including fecal incontinence, gas and oily discharge that spotted the undergarments of trial participants, are likely to limit the appeal of the pill.


-Sounds fine to me