1st OTC diet pill with OK from FDA in stores Friday Diet pill with FDA backing due in stores this Friday
A new weapon in the war against fat arrives Friday in pharmacies and at retailers across the nation, when alli, the first FDA-approved, over-the-counter diet pill alli, goes on sale.
Unlike the hundreds of other weight-loss products for sale without a prescription, alli (pronounced AL-eye), is the only diet drug deemed safe and effective by the Food and Drug Administration.
Dieters who stick to a low-fat, reduced-calorie diet and exercise regularly can lose more weight when they add the fat-blocking pill, according to manufacturer GlaxoSmithKline.
Some doctors are concerned about potential abuse, especially among youths, who are not authorized to take alli, and many people are skeptical that any pill is going to help people lose weight. Still others say potential side effects — such as gas and loose stools — may be a deterrent to those contemplating the drug.
Even so, Huntington Woods, Mich., resident Karla Scanlan says she may try alli if she does not lose 20 pounds in the next few months by eating a healthy diet and working out with a personal trainer.
"I might need a little help to get me over the hump," said Scanlan, who has tried low-carb diets and prescription weight-loss drugs in her quest to lose the weight she gained during two pregnancies.
"But I wouldn't take it as a substitute for eating healthy and working out."
Only two FDA-approved weight-loss drugs, Orlistat and Meridia, are currently on the market. Both are available only with a prescription.
In February, the FDA approved the sale of alli, a reduced-strength version of Orlistat, for people over age 18.
Although prices may vary from retailer to retailer, people can expect to pay about $50 for the 60-count starter kit, about $60 for the 90-count starter kit and about $75 for the 120-count refill package, company officials said.
Users should not take more than three pills in one day.
Available since 1999, Orlistat increases weight loss by blocking fat absorption. Clinical trials showed the drug helped people lose 50 percent more weight than just with dieting and exercise alone.
Taken with meals, alli works by blocking digestion of one-quarter of the fat consumed. Billed as a complete program rather than just a pill, the drug will come with a starter kit to help users understand how to find fat in their diets at home and when eating out.
Alli also comes with an online support plan — www.myalli .com — which gives people tailored messages on a weekly basis.
"We don't want people to try alli. We want people to commit to a low-fat, reduced-calorie lifestyle," said Brian Jones, vice president of communications for GlaxoSmithKline.
Specific fat intake
The drug maker emphasizes that people can only take alli when eating 15 grams of fat at each meal. A higher fat consumption could lead to unsavory side effects including gastrointestinal issues such as urgently needing to go to the bathroom.
The pharmaceutical company has been upfront about this, even recommending that people wear dark pants or bring a change of clothes to work until they adjust to the drug.
In spite of the claims and federal blessing, many people are skeptical about another diet pill on the market.
"If people want to lose weight, they should go on a diet and do a little exercise," said Kevin Fitzhugh, 51, of Allen Park, Mich. "These (drug makers) are playing on people's laziness."
Even some doctors have concerns that the drug could be abused by adults or even teens, despite an 18-and-up age requirement.
"There are potential issues that I am concerned about as a physician," said Paul Ehrmann, a Royal Oak, Mich., osteopath. "Time will tell. We won't know until it hits the market."
But this diet pill is safe and effective, said Gary Foster, director of the Center for Obesity Research and Education at Temple University in Philadelphia.
He called the FDA's over-the counter approval of alli "watershed, even historic" now that overweight Americans have one tool that they can turn to for help.
"I wish we had 10 (tools)," said Foster, who consulted for the drug maker on its online support program. "The more tools we have in this behavioral and biological battle, the better."
