FDA Considers Diet Pill As Over-the-Counter Drug; Internal Review Finds Use Could Lead to Vitamin Deficiencies, Abuse
Posted on: Wednesday, 25 January 2006, 00:00 CST
By THE ASSOCIATED PRESS
WASHINGTON - The Food and Drug Administration is considering whether to make a prescription diet pill that blocks the absorption of fat the first weight-loss drug it has approved for over-the- counter sales.
In 1999, the regulatory agency approved orlistat, marketed as Xenical, for sale as a prescription drug. Now, GlaxoSmithKline Consumer Healthcare seeks to sell an over-the-counter version of the pill.
That proposed version, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule. Two FDA advisory committees were to vote on recommending approval late Monday.
The agency usually follows the nonbinding recommendations of its outside panels of experts.
An earlier, internal FDA review found the drug is a "safe and effective weight loss agent," but held off on concluding whether it should be sold without a prescription. The review found that over- the-counter use of the drug could lead to vitamin deficiencies and encourage abuse.
When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed. That fat is passed out of the body in stools, which can be loose or oily as a result.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills, according to FDA documents.
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. The company has recommended patients take multivitamins when using the drug.
However, at least 47 percent of people ignored that advice in drug trials. Furthermore, just 35 percent of diabetes patients in a study correctly stated the drug was inappropriate for them, according to FDA documents.
Those sort of results worried FDA reviewers, who questioned the risk of selling the drug directly to consumers "without the principal involvement of a learned intermediary," or prescribing doctor.
The reviewers also showed concern about the increased potential for abuse or misuse of a prescription-free version of the drug, especially among bulimics or binge-eaters who could develop vitamin deficiencies due to chronic use.
The company said there was a "very low" potential for abuse.
British-owned GlaxoSmithKline's U.S. operations are based in Philadelphia and Research Triangle Park, N.C.
30
Source: Charleston Daily Mail
Related Articles
- URAC Calls for Public Comment on Revisions to its Pharmacy Benefit Management (PBM) and Drug Therapy Management (DTM), Version 2.0 Standards and NEW Performance Measures, and PHARM Core, Version 3.0 Standards
- Missouri Teens Turning Away From Street Drugs to Prescription Drug Abuse
- FDA Accepts Satraplatin NDA And Grants Priority Review
- Drugs From Astrazeneca/Renovis and Sanofi-Aventis Have the Potential to Revolutionize the Treatment of Several Neurologic Indications
- Aeon Sold Drugs Without Prescription in 17 Prefectures
- FDA Post-Marketing Studies Process to Be Reviewed
- First Check Receives First-Ever FDA Approval of an Over-the-Counter Home-Use Drug Test to Screen for Prescription Drugs - Now Available to Parents
- Heartburn Drug Prevacid to Be Sold Over the Counter in 2009
- FDA Bans Selling Mevacor Over-the-Counter
- FDA Panel to Consider Over-the-Counter Status of Cholesterol-Lowering Drug
 |
 |
User Comments (0)
RSS Feeds