GlaxoSmithKline
/ New York Times News Service
A mockup for alli, the new weight-loss drug. |
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The Food and Drug Administration yesterday approved the first officially sanctioned weight-loss drug to be sold without a prescription.
Experts expect the drug, alli, to be offered to consumers in the summer.
Though the medication has been available by prescription since 1999, some experts predict that it will be used more widely as an over-the-counter product. It will be the lone government-approved alternative to unproven over-the-counter remedies.
People in the United States spend about $1 billion a year on herbal formulas and other supplements that advertise fast weight loss but have no proven effectiveness and can be dangerous.
Dr. Curtis Rosebraugh, an FDA official, called the approval important in light of the array of unproven products on the market.
“It's rather 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,” Rosebraugh said.
Dr. Arthur Frank, an obesity specialist in Washington, said alli had a safe track record and could help patients lose 5 percent to 10 percent of their weight.
On the negative side, alli can cause side effects such as diarrhea.
The marketing plan calls for an emphasis on the need to diet and exercise while taking the medication. In studies, about half of those taking alli in combination with a diet-and-exercise plan lost 5 percent or more of their body weight in six months.
The manufacturer, GlaxoSmithKline, said it planned to sell the medication for $2 to $3 a day. The company has predicted that 5 million to 6 million people a year will use the drug.
The approval was issued as the government is under pressure to address an increasing obesity problem. Roughly 31 percent of adults, or 60 million people, meet the criterion for obesity. Experts say more than 64 percent of the adults are overweight.
The FDA is reviewing another weight-loss drug, rimonabant, that works on the pleasure centers in the brain to suppress appetite. It would be available only by prescription.
Alli is an over-the-counter version of a prescription drug, Xenical, that has been sold in the United States since 1999. Though Xenical is sold in 120-milligram doses, alli will be sold in 60-milligram capsules.
Glaxo studies have shown that the 60-milligram dose provides 85 percent of the weight loss of the higher dose. One capsule is supposed to be taken at mealtime.
The drug blocks the breakdown and absorption of fat in the intestine while blocking the absorption of calories from that fat. Fat that is not absorbed merely passes through the system, and that is the reason for side effects such as flatulence, oily stool and occasional loss of bowel control.
“Say you have a big, fatty meal. (Alli) blocks the absorption of a lot of fat, which is good, except that when you get a lot of fat way down in your colon, you have a chance of diarrhea, loose stools and unpleasant intestinal symptoms,” said Frank, medical director at the George Washington University Weight Management Program.
Through its intestinal side effects, the drug also creates an aversion to eating excessive fat – another reason it works, said Frank, who has been on an advisory panel for Glaxo.
Dr. Jana Klauer, a weight-loss and nutrition specialist in Manhattan, said the side effects had been a deterrent to alli as a prescription medication.
“I haven't had terrific success with it,” Klauer said. “My patients just don't like the side effects. I use it a little bit, but not a lot.”
Studies have shown that the intestinal symptoms are somewhat lower at the over-the-counter dose, the FDA said. The side effects also can be minimized by eating a diet of no more than 30 percent fat.
Glaxo will package capsules with seven pocket reference guides that provide advice on meal planning, what to order when eating out, a fat-and-calorie counter and a journal for recording daily food intake.
The educational plan will include a Web site, myalli.com, where patients will be able to log in, track progress and obtain personalized advice.
The product was approved despite protests from the Public Citizen Health Research Group. That group cited studies linking the prescription version with precancerous changes in the intestine.
Frank said the product has a good safety record.
“It's safe,” he said. “There's no question it's safe. It's a nonsystemic drug. It's not absorbed by the intestine. The only thing it does it runs through the intestinal tract and drags out some fat with it.”
Klauer said the potential for abuse was a concern.
“Whenever anything is over the counter, there is a potential for abuse, and I have no doubt that that's going to happen,” she said. “I think people who don't really need it will take it. People who don't need to lose weight will take it.”
Because alli blocks the absorption of some vitamins, people who use it must also take a multivitamin.
Selling alli to children is not prohibited. The label will say it is intended for use by those 18 and older.
