Very First Nonprescription Diet Pill Approved by the FDA

WASHINGTON (AC) -- The Food and Drug Administration approved the first diet pill that can be bought without a prescription in a marketplace dominated by unregulated over-the-counter weight loss supplements, yesterday.

GlaxoSmithKline Consumer Healthcare plans to begin selling this drug, known as Alli, as early as this summer for an estimated 70 cents per dose. A higher dosed version of this diet pill has been available in the United States since 1999.

Alli can result in modest weight loss when used in conjunction with reduced-calorie, low-fat diet and exercise. The FDA said that in GlaxoSmithKline studies, about 28% of individuals testing the drug were able to lose 5 to 10 percent of their body weight. Dr. Charles Ganley, the director of the FDA's Office of Non-Prescription Products, strongly stated that without exercise and diet, the new drug, Alli would not be effective. "The emphasis in the labeling is on that," Ganley said. The company estimates approximately 5 to 6 million Americans would buy the drug over the counter each year.

People who use blood thinning drugs and those with diabetes or thyroid disease will be advised to consult their physician before consuming Alli. Individuals that have received organs transplants will be warned not to use Alli because of the potential for adverse drug interactions. The drug can cause nutrient loss and the label recommends taking a multivitamin at bedtime to offset this loss.

Unlike other products that can be purchased over the counter and taken by consumers as young as 12 years old, the FDA approved Alli for sale only to individuals who are 18 years old or older. However, the FDA stopped short of regulating who can access the drug by not putting restrictions requiring that it be placed behind a pharmacist's counter or requiring proof of age at the checkout counter. The Food and Drug Administration does not endorse its use by young people and GlaxoSmithKline has agreed not to target those under the age of 18. Safety risks associated with improper use, even by adolescents, were "quite low," Ganley said.

GlaxoSmithKline hopes to get their new product in front of consumers as early as mid April through various forms of adverting. GlaxoSmithKline's marketing campaign goal is to ensure that the right consumers purchase the product, said Steven Burton, vice president for the company's weight control division.

The generic form of the drug is called Orlistat and was approved by the FDA in 1999. Roche Holding AG continues to sell the prescription version under the name Xenical, which absorbs about 30% of consumed, fat.

Alli works by blocking absorption of about 25% of any fat consumed. It comes in capsule form and can be taken up to three times a day. The possible side effects include gastrointestinal problems such as gas, loose stools, oily spotting and bowel movements that are difficult to control, some of which can be severe. Approximately 50% of the test patients experienced some type of gastrointestinal side effect. The FDA said that a low-fat diet could help to minimize some of these side effects.

Some watchdog groups are saying that studies have shown that it caused pre-cancerous legions in rats are also claiming it can increase the chance of colon cancer. The company claims that these statements are invalid and that Alli is the most studied weight loss drug in history.

The weight loss pill was named Alli to show consumers that they are partners with them in their weight loss efforts because of the increased risk of health problems caused by obesity.

Sources: CNN, Boston Globe, Fox News