William Macklin - All Headline News Staff Reporter
Washington, D.C. (AHN) - In a first likely to shake up a diet industry bloated with bogus or unproven products; the Food and Drug Administration has approved over-the-counter sales of a weight loss drug.
The drug, orlistat, will be the first medication of its kind available without a prescription. Orlistat is currently available by prescription under the brand name, Xenical, but the FDA's ruling Wednesday will make the drug available to millions of new consumers seeking ways to shed pounds, some experts predict. The over-the-counter version of the drug will be sold under the name "Alli."
The FDA has faced complaints that the $1 billion diet industry is glutted with unproven and sometimes unsafe products. Officials at the FDA say lifting the prescription requirement on orlistat is an important step towards addressing those concerns.
Dr. Curtis J. Rosebraugh, an official with the agency, told the New York Times that it is "significant that there will now be available an over-the-counter product that we do have data on, that we know is efficacious and what the safety profile is."
Potential benefits aside, the drug can produce side effects, including diarrhea and oily stools.
And the FDA is quick to point out that Alli isn't a magic bullet. Users must still eat less and exercise more if they hope to lose weight on the drug.
Dr. Charles Ganley, FDA's director of nonprescription products, told the AP that "Using this drug alone is unlikely to be beneficial."
Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.
The drug works by blocking the absorption of about one-quarter of food fat consumed. The fat is then passed out of the body in stools.
Some critics of orlistat have complained that side effects, such as fatty stool, only hint at the medication's true dangers.
Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, told the AP that he considers the FDA's approval "the height of recklessness," and cited studies he said associated the prescription version of the drug with pre-cancerous lesions of the colon. Wolfe also called for withdrawal of the prescription version.
Dr. Arthur Frank, an obesity specialist in Washington, countered that orlistat has a safe record and told the Times the drug could help patients lose 5 percent to 10 percent of their weight.
GlaxoSmithKline, the company that makes Alli, said it intends to market the medication for $1 to $2 for a day's dose, and predicts that five million to six million people a year will it, the Times reports.
Xenical, which is made by Roche Holding AG, is typically prescribed in 120-milligram doses. Alli will be sold over-the-counter in capsules of 60-milligrams.
The FDA decision comes as the agency is facing mounting pressure to help address the nation's growing obesity problem.
About 60 million Americans, roughly 31 percent of all adults, are clinically obese; 64 percent are overweight, studies show.
