A New Breed of 'Diet' Pills

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The focus on other drugs comes amid a growing obsession with weight and obesity. Many people are fed up with over-the-counter dietary supplements, which often don't work. Some say they perceive prescription drugs -- which are more strictly regulated -- to be safer, especially in the wake of the FDA's warning to consumers a few years ago to stop taking the dietary supplement ephedra, which was sold over-the-counter, in part because it could damage the circulatory system.

Part of the reason people are so eager to take off-label drugs to lose weight, according to doctors and patients, is that there hasn't been a truly promising short-term weight-loss medication on the market since the FDA withdrew approval for fenfluramine in 1997 after it was linked to heart-valve problems. (Fenfluramine had been commonly given to patients along with phentermine, another appetite suppressant; the combination, which was never approved by the FDA, was known as fen-phen. Phentermine is still approved for short-term weight loss.)

For obese patients seeking long-term weight loss, there are just two approved drugs on the market -- Meridia and Xenical. Some doctors say they are reluctant to prescribe Xenical because it can produce distasteful side effects such as abdominal cramping, gas and anal leakage. Meanwhile, Rimonabant, a medication that is showing promising results for weight loss in some people in the United Kingdom, hasn't yet been approved by the FDA for use in the U.S.

Filling a Void

The doctors who prescribe drugs off-label for weight loss believe they fill a void. "Obesity is a chronic disease -- diet and exercise aren't enough for long-term weight loss for most patients," says Robert Skversky, a bariatric physician in Newport Beach, Calif. "Chronic diseases need drugs to keep them under control."

Dr. Skversky uses a combination of drugs he adjusts for each patient -- a drug cocktail usually consisting of phentermine plus antidepressants such as Prozac, antiseizure drugs such as Topamax or Zonegran, or diabetes drugs such as Glucophage or Byetta. (Ms. Krawczyk, who is one of his patients, takes Adipex, or phentermine; the antidepressants Wellbutrin and Celexa; and Topamax.) A combination of these drugs could cost about $100 to $200 a month or more, says Dr. Skversky.

Dr. Skversky, who tells his patients that they will be on these drugs for life, says the benefits far outweigh the side effects. "We rarely stop anyone because they can't tolerate a drug, because we can adjust the dose or the combination," he says. A number of his patients, he says, have lost more than 100 pounds. He also encourages his patients to exercise and eat high-protein, low-carb diets.

Other doctors say that although they see less-dramatic results, off-label drugs can still be valuable weight-loss tools. Ann Wry, medical director of Women's Health Services at Hackensack University Medical Center, in Hackensack, N.J., sometimes prescribes Wellbutrin -- a drug she feels has minimal side effects -- if she thinks it will help a patient lose weight. (She also encourages patients to follow a balanced diet and exercise program.) "It doesn't produce a ton of weight loss, but it takes the edge off of hunger," she says. "If someone is trying to do South Beach or Weight Watchers, this diminishes the craving enough so that they can say, 'No, I've had enough.' "

The pharmaceutical companies that manufacture these drugs warn that they shouldn't be taken for weight loss. Both types of Adderall -- short- and long-release -- carry a black-box warning against their misuse because they can cause sudden death or serious cardiovascular events. (The drug can also cause dependency or addiction.) Topamax can cause confusion or difficulty concentrating, while Provigil can cause dizziness or insomnia.

For Theresa Saleeby, the ill effects ended up overshadowing the benefits of taking a drug to lose weight. When she decided she wanted to lose about 50 pounds last year, her doctor prescribed Topamax. He told her that most patients lost between 20 to 50 pounds on the drug and that it would help prevent her migraines. But after taking the medication for seven months, she weighed in at 175, just three pounds less than when she started.

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Even more upsetting, Ms. Saleeby says, were the side effects: While on Topamax, she had minor memory loss, her legs regularly fell asleep, and her hair fell out in patches, one of which was the size of a baseball.

"These minor side effects aren't that minor," says Ms. Saleeby, 31, a real-estate agent in South Orange, N.J. After the hair loss, she stopped taking the drug, then cried for a week. "I'd rather be chubby than bald," she says.

Source: WSJ

Last updated: 08/06

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