Originally published February 26 2006
GSK exec says Orlistat is no magic pill
by Mike Adams, the Health Ranger, NaturalNews Editor
John Dent, senior vice president of research and development at GlaxoSmithKline, talks about the role Orlistat plays in helping people to control their caloric intake.
A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final FDA approval before it can sell the nonprescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults for use as a weight-loss aid.
The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing.
The agency usually follows the recommendations of its outside panels of experts.
Currently, the FDA has not approved any nonprescription weight-loss drugs for sale.
''There is no magic pill for weight loss.
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.
In six-month trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those given dummy pills.
The proposed over-the-counter version, called Alli (pronounced ``ally''), would contain half the dose of the prescription capsule and would be intended for use by overweight adults.
However, the pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products.
A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
The primary concern of FDA reviewers was the drug's potential to create vitamin deficiencies, since its use also blocks absorption of fat-soluble vitamins like D, E, K and beta-carotene.
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