Alli slimming pill safety under question

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, therapists fear.

Alli — pronounced “AL-eye” — is the only weight-loss medicine on the market approved by the federal Food and Drug Administration. It’s half the dose of the prescription drug orlistat, trade name Xenical, which is used to fight morbid obesity.

Dr. Randall Flanery, head of the Eating Disorders Program for the St. Louis Behavioral Medicine Institute, said the new drug is ripe for abuse because young people with eating disorders find the side effects of intense diarrhea and other gastrointestinal problems that empty the digestive system inviting.

People who use diet products to bolster their eating disorders “tend to take them at much higher dosages than recommended, as much as 10 times,” Flanery said. “It’s analogous to laxatives. People with eating disorders take 10 to 50 (laxative pills) at a time. They become dependent and take higher and higher dosages.”

Another danger is that the medicine is approved by the FDA “and people will believe that because it’s over-the-counter and FDA-approved, it must be safe,” Flanery said. “It’s not.”
The drug should be kept behind counters and monitored for distribution to make sure that at least teens don’t have access to it, Flanery said.

What is it?

The FDA approved Xenical nearly 10 years ago. It limits the absorption of fat so that the fat doesn’t enter the bloodstream as triglycerides. Triglycerides are used for fuel and are stored in fat cells. In excess, they clog the blood vessels and help cause heart attack, stroke and organ failure. They can elevate because you eat too much fat or because you have a disease such as diabetes.

The FDA approved Alli in February at 60 milligrams. (prescription-strength Xenical is sold in 120 mg capsules.) The manufacturer, GlaxoSmithKline, said in its advertising literature that the drug can increase weight loss by 50 percent if it’s used along with a reduction of fat intake and an increase in exercise.

But you can experience oily diarrhea, flatulence and other intestinal side effects.

Not unanimous

A weight-loss specialist said anything Alli can do can be done for a tiny fraction of the cost by medications that are easier to purchase by minors.

“There are a lot of cheaper ways to get diarrhea,” said Dr. Samuel Klein, head of the Weight Management Program at Washington University in
St. Louis. “This medication is $60.” That’s for 90 pills.

“It’s half the dosage (of the prescription version), and the manufacturer is marketing it responsibly as something that needs a change in lifestyle to work,” Klein said.

Also, he said, the gastrointestinal problems are bothersome enough that even someone with an eating disorder wouldn’t want to face them, especially with easier alternatives.

Eating disorders

Flanery’s concern is that people with anorexia nervosa and bulimia — about 1 percent of the female population younger than 24 and a growing number of men — use a bunch of tricks to get thinner.

The tricks include faking eating, taking laxatives, purging (vomiting a meal), isolating themselves and taking amphetamines to reduce appetites.

Debbi Kuehnel, a counselor and owner of the Eating Disorder Recovery Center, wants the drug to be taken off the market. People with eating disorders are as prone to trends as anyone, and Alli’s newness could be its attraction, she said.

“We already had a client who stole a bottle,” Kuehnel said. “She took 10 pills. They don’t care about the side effects.

“Putting this drug on the market was ridiculous,” she continued. “The ads say eat right, exercise and change your lifestyle and use the drug. You’ll lose weight if you eat right, exercise and change your lifestyle; you don’t need the drug.

“The prescription dose was meant for people who are morbidly obese; there’s no need to make it over-the-counter.”

Via http://www.holmencourier.com/articles/2007/08/23/news/drug.txt

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