990502 FDA Approves Fat-Blocking Diet Drug

Los Angeles - The menu at Pink's is a dietitian's nightmare: hot dogs, hamburgers and french fries augmented with healthy doses - so to speak - of chili, cheese, sauerkraut or bacon.

For the adventurous - or indecisive - there's the $3.90 pastrami burrito dog.

And for the dieters, how about a chaser of Xenical?

The highly anticipated diet pill, which earned government approval, sounds like a Pink's patron's dream. It blocks the body from absorbing 30 percent of the fat a person eats.

But medical experts warned the drug - the first that works in the gut instead of targeting the brain to suppress appetite - is only for obese people on strict diets and can cause unpleasant side effects, especially if someone pops a pill just before indulging in a greasy burger.

“We're always looking for the next magic drug, but there's no pill people can take that'll make you close the refrigerator door,” said Dr. David Heber, director of the Center for Human Nutrition at the University of California, Los Angeles.

At Pink's, which has served up its cuisine since 1939 in Los Angeles' Miracle Mile district, customers said they would stick with exercise and better eating habits, considering the drug's potential downside.

“I prefer a more natural way of losing weight if I had a choice,” said Jaime Parker, as he waited in line for his chili cheeseburger.

Xenical, known chemically as orlistat, blocks intestinal enzymes. So instead of being stored on people's hips, 30 percent of the fat eaten passes straight to the colon for excretion.

In studies, adding Xenical to a diet let people lose about 71/2 pounds more in a year than diet alone, the Food and Drug Administration said.

Because of the way it works, Xenical can also cause intestinal cramping, oily spotting, gas, fecal urgency, and oily or loose stools. Some 27 percent of Xenical users had at least one episode, although the side effects tend to wane the longer people take the drug.

Still, the more fat eaten, the more side effects - thus, the FDA recommended that Xenical users get no more than 30 percent of their daily calories from fat.

Experts said the side effects will keep many dieters from the kind of haphazard use that plagued Redux and the fenfluramine half of “fen-phen,” which were banned for causing heart damage. Both were very popular and sometimes bought on the Internet without consultation with a doctor.

Xenical “is not a drug for people who want to eat whatever they want,” said Heber, whose center treats thousands a year. “Those gastrointestinal side effects will be enough to turn a lot of those people off.”

For Xenical to do any good, dieters have to eat fewer overall calories, not just watch fat, said Dr. Richard Atkinson of the University of Wisconsin, president of the American Obesity Association.

As for people who “eat the pizza and milkshake and take this drug and think it's going to absolve them of all their sins, they're going to be in for a surprise,” Atkinson said.

Xenical also decreases absorption of the important fat-soluble vitamins A, D, E and K, so users should take vitamin supplements two hours before - or after - swallowing Xenical.

Dieters take one Xenical capsule with each main meal, up to three daily. Manufacturer Hoffman-La Roche said the prescription-only drug would be available within two weeks, at a wholesale price of $1.10 per pill.

Only two other prescription weight-loss drugs are sold in the country. Doctors expect many dieters will begin taking Xenical with those appetite suppressants to shed even more pounds. But the FDA warned no one has studied the safety of mixing the drugs, and Roche has no plans to do so.

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