Wednesday, February 14, 2007

FDA approves first OTC weight loss pill

The Food and Drug Administration (FDA) approved an over-the-counter version of the fat-blocking diet drug Xenical last week, making it the first FDA approved weight loss product available without a prescription.

The drug will be sold under the brand name Alli and will contain about half the amount of the fat-blocking drug orlistat than the prescription version contains.

GlaxoSmithKline, the company that manufacturers the pill, expects the drug to be in stores by summer 2007.

Alli blocks the absorption of about 25 percent of the fat consumed when taken at meal times. The fat is then passed out of the body through stools and eliminates about 150 to 200 calories from fat.

Consuming a high-fat meal while using Alli can result in uncomfortable bowel changes such as loose stools or a sudden urge to use the bathroom, Brian Jones, vice president of communications for GlaxoSmithKline.

According to a press release, the recommended dose is one 60-milligram capsule, three times a day, with meals.

"It is about 60 cents a capsule," Jones said. "It is certainly affordable for most Americans. It's about the cost of a soda and a bag of chips."

The drug is intended for people 18 and older and because of the way it works, the company recommends that it be used in combination with a healthy lifestyle, exercise, and a reduced-calorie diet that contains about 15 grams of fat per meal.

"Essentially, you have to follow a low-calorie diet to be successful," Jones said. "It's not a magic pill that will cause you to lose weight in hours."

Users will lose weight steadily over time, Jones said.

Associate professor of nutritional neuroscience Rebecca Corwin said she is not an advocate of using drugs as a long-term solution for weight loss.

"I think they're okay in moderation," Corwin said. "The critical thing is that people have got to learn healthy habits if they're going to be successful in the long-term. That's the tough part."

Corwin said diet drugs work in two ways, reducing fat absorption and causing users to change their eating habits to reduce side effects.

"They reduce fat absorption in the [gastrointestinal] tract and reduce the actual amount of fat your body gets by about 30 percent," Corwin said.

"Also, if people break the diet and eat a lot of fat, they feel really uncomfortable," she said.

Users are also urged to take a multivitamin once daily because Alli has the possibility of reducing the absorption of certain nutrients, Jones said.

Corwin said she thinks taking a multivitamin could be helpful because of the vitamins that may be prevented from absorption.

"It's probably going to be the fat-soluble vitamins A, D, E and K," Corwin said. "It certainly won't hurt to take a multivitamin. Just make sure that it's no more than 100 percent of the recommended daily allowance."

Leslie Archard (sophomore-marketing) said she thinks people will take such diet drugs even though they are aware of the potentially unpleasant side effects that may happen as a result of taking the drugs.

"People are so insecure that they'll do it anyway," Archard said. "There's a strong drive to be considered attractive and they are making money off of people's insecurities."

About 31 percent of American adults, or 60 million people in the United States meet the criteria for obesity, according to the Centers for Disease Control and Prevention. About 65 percent of American adults are considered overweight.

"About two-thirds of American adults are overweight or obese," Jones said. "We need help. Maybe this is one of the things that can help us."

Why alli is different from other diet pills?

Unlike other products on store shelves, alli is a proven medicine with a comprehensive support program. To help consumers get off to a successful start, the alli package will include Welcome and Companion Guides, a Guide to Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact Cards, and free access to an individualized online action plan at http://www.myalli.com.

"With alli , we're excited to offer a revolutionary approach to weight loss," says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. " alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That's the way to see results, and with alli , we know they can do it."

Starting today, GSK Consumer Healthcare will gear up production to have the product ready for shipment and in stores by the summer. The company is using this period to build awareness and understanding about the product and its intended user �" with the message �" alli is not for everyone. It's for the committed consumer who can follow a reduced-calorie, low-fat diet. For this consumer, alli will provide a unique, proven approach to weight loss, offering straight talk, educational tools and an online support program �" myalli.com.

GSK - alli: learn from the mistakes of others

Advertising prescription medicines direct to consumers is illegal in Australia, so one side benefit for pharmaceutical companies of having a drug reclassified from "prescription only" to "pharmacist only" or "pharmacy medicine" is that the drug can then be advertised, potentially expanding its market.

This happened to the weight loss drug Xenical (aka olistat aka "alli"), initially available only on prescription, which in 2004 was rescheduled as a "pharmacist only" drug and in 2006 given limited advertising approval.

However, this may be short-lived.

The classification of Xenical will be re-considered next week after complaints from consumer groups and the general public that it was being promoted as a weight loss solution to people for whom the drug is not recommended, including young people under 18 where the safety of Xenical has not been established.

These complaints focussed on the advertising of Xenical during television programs targeting young people. The advertisements have now been withdrawn after they were found to breach the advertising code for medicines. But not before they were seen by the estimated 1.3 million viewers of the popular Australian Idol program, including many who were aged under 18.