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Off-label prescribing

Off-label prescribing rampant as doctors give patients amphetamines, psychotropic drugs for weight loss

Thursday, August 24, 2006 by: NewsTarget
Tags: off-label prescribing, bad medicine, prescription drugs


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(NewsTarget) Earlier this week the Wall Street Journal reported that many doctors engage in "off-label" drug prescribing to help patients lose weight, which involves prescribing medications for weight loss that have not been approved by the FDA for that purpose.

According to WSJ's article, doctors across the country sometimes prescribe antidepressants or anti-seizure drugs to patients without those disorders, to help them lose weight, even though such drugs are not approved for weight loss. Popular "off-label" weight loss drugs include ADHD or antidepressant drugs such as Adderall, Ritalin and Wellbutrin.

Dr. George Blackburn, associate director of Harvard Medical School's Division on Nutrition, told WSJ: "There is no evidence of the safety or the efficacy of going off-label for weight loss."

Though pharmaceutical companies warn consumers against taking their products for weight loss -- as side effects include abdominal pain and anxiety -- the companies' massive increases in profits from popular off-label drugs suggest such warnings aren't effective. For example, sales of the ADHD drug Adderall have jumped by 3,000 percent in recent years, while Wellbutrin -- an antidepressant -- has enjoyed a 1,000 percent sales increase since 2003 to bring in $1.4 billion in 2005.

Defenders of off-label prescribing -- who critics say enjoy financial perks as a result of over-prescribing expensive medications -- say obese patients need more than diet and exercise to lose weight.

Dr. Robert Skversky, a California bariatric surgeon, says he prescribes a cocktail of drugs for patients to help them lose weight, including antidepressants such as Prozac, and the weight-loss drug phentermine. Skversky says he instructs his patients that they will be on such drugs for the rest of their lives, claiming that the benefits of such prescriptions far outweigh the side effects.

However, some recipients of such off-label prescriptions disagree that the side effects are worth the weight loss. New Jersey resident Theresa Saleeby, 31, says she lost only 3 pounds after seven months of taking Topamax -- an anti-seizure drug she was prescribed despite the fact that she does not suffer from seizures. Saleeby says the drug caused her memory loss, made her legs fall asleep and caused her hair to fall out in large clumps.

"I'd rather be chubby than bald," Saleeby told the Wall Street Journal.

"Off-label prescribing is the dirty little secret of so-called 'evidence-based medicine'," said Mike Adams, an outspoken critic of prescription drug abuse. "There is exactly zero evidence that these drugs are either safe or effective for weight loss, and yet the FDA turns a blind eye to the practice of off-label prescribing, and drug companies profit handsomely from it," he said. "It is blatant scientific fraud to call our current drug approval process 'evidence-based medicine' when a drug approved for one specific thing can be legally and openly prescribed for totally unrelated health conditions."

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