LIMOMx2
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Member since 5/05 24989 total posts
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Re: Alli - The new FDA approved over the counter weight loss pill...
Losing weight may not be easy for many overweight or obese people, but GlaxoSmithKline Consumer Healthcare, L.P., the second largest drug maker in the world, may have made it easier for them to get an over-the-counter(OTC) form of Roche's prescription weight loss diet pill Xenical®.
After reviewing Glaxo's application for selling a variant of Xenical on the OTC market, a government-appointed advisory committee on Jan. 23 voted 11 to 3 recommending that the Food and Drug Administration (FDA) approve the weight loss diet pill containing 60 mg of orlistat(tetrahydrolipstatin) for OTC use in the US.
The OTC diet pill will be marketed by GlaxoSmithKline under the trade name Alli (pronounced AL-eye). It would be the first FDA-approved weight loss medication available over-the-counter if the FDA okays the application as expected. FDA usually follows the recommendations of its advisory committee, but it is not obligated to.
Alli is chemically no different from the existing prescription diet pill called Xenical®, except that it contains only 50 percent less of a dosage of orlistat in Xenical®(120 mg per capsule).
Xenical® was approved by the FDA in 1999 to assist obese people to lose weight. It is the prescription form of the drug orlistat. Alli is not intended to replace Xenical®, which remains available through a physician.
Alli with an active ingredient orlistat, a drug that helps lose weight by blocking fat absorption in the small intestines, is recommended for use by overweight (not obese) adults along with a reduced calorie, low fat diet, according to Glaxo. The low fat diet is defined as a diet with less than 30 percent calories from fat.
The efficacy of Alli was demonstrated in clinic trials over six months. On average, those taking three pills a day lost 5.3 to 6.2 pounds. About 50 percent of participants experienced the effect, compared to 26 percent taking a placebo.
However, the weight loss effect diminished and lost weight came back after use of the drug was discontinued. Those who want to keep the pounds off need to keep taking the pill. The OTC orlistat, Alli, is intended for use in adults over 18 years old over a period of six months.
Alli is generally viewed as safe. However, some of the FDA panelists have concerns about the drug after it hits the OTC market. Some worry that patients may abuse the drug. People with eating disorders may use the drug to purge fat they eat.
Some worry about the fact that a high percentage of patients were not well informed of the side-effects, which would cause problems in certain individuals. For instance, using Xenical® could cause problems for organ transplant patients on the drug cyclosporine as well as those on warfarin, a blood thinner.
Xenical®, Alli alike, is not intended for everyone. Those who have problems absorbing food, have gallbladder problems and/or are pregnant or breast-feeding should not take the diet pill. For diabetics, the drug may affect blood sugar control.
Other side effects include gas with discharge, oily discharge, increased number of bowel movements, oily spotting, oily or fatty stools, urgent need to have a bowel movement and inability to control bowel movements. About 50 percent of patients on Orlistat experienced some side-effects and seven percent lost bowel control.
The committee, namely the FDA joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee, recommended Glaxo closely monitor the safety of the OTC orlistat after Alli hits the market.
To maximize the weight loss effect and minimize side effects, Alli, unlike any other drug, will need to be used with other supports. In addition to using a low fat diet, the patients need to do physical exercise.
Because much of dietary fat is not absorbed, many fat-soluble vitamins need to be supplemented in the diet, or patients need to take a multivitamin supplement that contains vitamins D, E, K, and beta-carotene.
To overcome potentially embarrassing side effects, people on the medication will need to take a drug to manage bowel control.
While weight loss is slow, modest and maybe only temporary, Alli is costly. According to Glaxo, 90 capsules will cost $55 or $12 to 25 a week. Three capsules a day, used along with three meals, is likely needed to have an effect. To lose 5.7 pounds in six months, one may have to pay $300 or more. The hefty cost may return a loss of less than 5.7-pound weight in 50 percent of the people who use the OTC weight loss diet pi ll.
Use of Alli does not seem as simple as one pill plus one glass of water equals weight loss. Glaxo says a 250-page instruction will be offered along with the product to help people. Overall, using orlistat seems quite a task for people, considering it only causes a modest weight loss.
Sidney M. Wolfe MD and Elizabeth Barbehenn, Ph.D., with Public Citizen's Health Research Group, on Jan. 23 testified before the FDA advisory committee raising their concerns based on certain facts little known to outsiders.
They said that, "The long-term effects of Orlistat on morbidity or mortality associated with obesity have not been established." Glaxo did not report how Xenical® or Alli affects blood pressure and serum lipids, which are commonly associated with obesity.
"Although a statistically significant weight loss for Orlistat 60 mg compared to placebo is seen, there is no evidence presented that a modest, transient weight loss due to orlistat will afford any long term clinical benefit either through a change in behaviuor or a reduced risk of serious clinical disease manifest by being overweight," Wolfe and Barbehenn said in their testimony.
"Physicians are increasingly rejecting the prescribing of Orlistat (decrease from 2.6 million US prescriptions in f.y. 2000 to 1.0 million in f.y. 2004). It is clearly in GSK's (and partner Roche's) interest to seek OTC approval. Your committees need to reject this desperate attempt to revive this barely effective drug by an OTC switch."
"We are excited by the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss. Alli will be more than a pill; it will be a program that will help people lose weight, adopt a healthy eating plan and make other lifestyle changes," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.
"We look forward to working with the FDA to gain final approval."
Orlistat is the drug name.
Xenical® is the trade name or representative name for the drug orlistat.
Alli is the tradename for the over-the-counter drug orlistat.
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NewlyMrs
Laugh-Live-Love LIFE!
Member since 10/06 14432 total posts
Name:
Jennifer
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Re: Alli - The new FDA approved over the counter weight loss pill...
I too never beleived in drugs either!
Weight loss is nothing more than a little determination, self control, good eatting, and exercise!
The trick is finding things YOU like. Not things others like, that ultimately lead to failure for you!
It does not sound safe to me....
gas with discharge, oily discharge, increased number of bowel movements, oily spotting, oily or fatty stools, urgent need to have a bowel movement and inability to control bowel movements. About 50 percent of patients on Orlistat experienced some side-effects and seven percent lost bowel control.
To maximize the weight loss effect and minimize side effects, Alli, unlike any other drug, will need to be used with other supports. In addition to using a low fat diet, the patients need to do physical exercise.
Because much of dietary fat is not absorbed, many fat-soluble vitamins need to be supplemented in the diet, or patients need to take a multivitamin supplement that contains vitamins D, E, K, and beta-carotene.
To overcome potentially embarrassing side effects, people on the medication will need to take a drug to manage bowel control.
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