From Deseret News archives:
Over-the-counter sales of diet pill urged
FDA advisory panel gives OK to orlistat, now sold as Rx only
GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. 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, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.
"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," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.
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, she said. Quesnelle said people could resume use or seek help from a doctor if they gain weight.
"I think the drug is safe enough to be OTC. It's an OTC indication. Although there are some i's that need to be dotted and t's crossed, it's suitable for OTC use," panel chairman Dr. Alastair Wood said following the vote.
The panel requested that the company conduct follow-up studies if and when the drug does reach the market, as well as rework the pill's label to ensure its proper use, Wood said.
Glaxo said the drug helps the overweight slim down only when combined with a diet and exercise regimen. The drug's actual effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.
"There is no magic pill for weight loss and orlistat is not a magic pill. 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.
Comments
- Mavs' Nowitzki hits fallaway winner 9:12 p.m.
- Kings rally past Panthers in SO 9:03 p.m.
- Guerin sparks Penguins past Ducks 8:44 p.m.
- Voracek lifts Blue Jackets past Oilers 8:42 p.m.
- Hawks beat Blazers in OT 8:40 p.m.
- Ravens, Browns scoreless at halftime 8:38 p.m.
- Jazz rookies a bit more seasoned 8:35 p.m.
- Tepanyaki will pay $30K settlement 8:30 p.m.
- Nu Skin milestone at NYSE 8:30 p.m.
- GM to pay back $6.7B debt to gov't 8:29 p.m.
- MWC expand? Get rid of deadweight
- Relieved Cougs prep for Falcons
- Wounded Utes limp home
- Jazz rookies had to grow up quickly
- Big games keep UHSAA coffers full
- Barzee to plead guilty
- Sloan misses practice
- RSL surprised by Chicago's Fire
- Vitamin D deficiency puts U.S. at risk
- Jazz notes: Young bigs ride bench
- TCU creams U.
233 - BYU happy to escape with victory
232 - Editorial: Mormons and gay rights
225 - Will state consider gay rights law?
162 - RSL heads to MLS title game
134 - Can BYU root for (ick) Utah Utes?
132 - MWC expand? Get rid of deadweight
117 - TCU stays 4th in AP; Y. 19th, U. 23rd
115 - 5A: Bingham rolls to title game
108 - 3A: Hurricane advances to title game
89
I was a bit under the weather last week, which gave me some time to...
How do you handle kids and contests? Our oldest daughter, 7, is of the...
I know exactly what I'm going to write mine on. This is such a great...
Elder Taylor, son of the deceased, is an outstanding young man and missionary...
I was extremely happy to see Bingham beat Alta in the playoffs after two...
What amazes me is that none of these "smart" sports writers fail to see how...
"One day however" thanks for your contributions...maybe one day the people...
I'm all for civil rights, but what is a religion doing invoking their ideals...
When did Christ visit Asia??? Buddha was not Christ!
"Small schools travel better than the big ones." No, they just travel...
Sarah could save her prayers for getting the help she needs to speak publicly...
please, please, please end the relationship with the scouts and focus on DTG.


You can be the first to comment on this story.