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Re: risperdal for anxiety

Posted by JLM on December 31, 2003, at 20:28:42

In reply to Re: risperdal for anxiety, posted by leopard on December 28, 2003, at 2:25:15

Are there any gold label studies that shows Risperidone is effective for anxiety, or ANY studies at ALL for that matter?

Here's a nice little ditty about Risperidone, and off label prescribing:

"Victims of off-label prescribing whom Knight Ridder interviewed have suffered heart attacks and strokes, had permanent nerve damage or lost their eyesight. Most said they never were told that the FDA hadn't approved their treatments.

Based on the FDA's own data, Knight Ridder estimates that at least 8,000 people became seriously ill last year after taking some of the nation's most popular drugs off-label. The true number is likely to be many times higher.

"Sometimes it may help, sometimes it may do more harm than good and sometimes it may kill people," said Arnold Relman, a former editor of the prestigious New England Journal of Medicine.

Despite the rise in off-label drug use, the FDA has done little to discourage it, and is considering whether to allow drug companies greater leeway in pushing unapproved therapies.

George Murphy's hands, made strong by years of climbing utility poles for Houston Lighting & Power, shake with tremors. His legs, now rigid, shuffle as he pushes his walker through his studio apartment in Deer Park, Texas.

"I wish I didn't have to use this thing," he said as the walker snagged on his recliner while he was showing off his Army dog tags from World War II, a plaque for 40 years of service as a Mason, his Shriner fez and the oil paintings his wife did a few years before she died.

Murphy, now 85, began having the tremors last year after he had a series of strokelike attacks while taking Risperdal, a powerful antipsychotic drug that the FDA has approved only for treating schizophrenia.

Murphy's family practitioner in Pasadena, Texas, Dr. Dennis Yaworski, prescribed Risperdal for an off-label purpose: "cancer phobia," according to case notes from an office visit on Sept. 9, 2002.

The drug's maker, Johnson & Johnson, has marketed Risperdal heavily to doctors who treat elderly patients.

In 1999 the FDA cited Johnson & Johnson for downplaying the drug's risks to the elderly and making false and misleading claims that it could be used not just to treat schizophrenia, but also "for psychotic symptoms associated with a broad range of disorders."

While doctors are free to prescribe as they wish, the FDA prohibits drug-makers from marketing unapproved treatments.

Despite the FDA's action, Risperdal has become a popular off-label treatment for Alzheimer's disease and dementia. About 670,000 such prescriptions were written last year, up more than 350 percent from 1998, the Knight Ridder analysis found. Sixty-five percent of Risperdal's prescriptions last year were for unapproved treatments, generating $929 million in retail sales.

Then in April 2003, Johnson & Johnson sent a letter to U.S. doctors warning that Risperdal may be associated with an increase in strokes when prescribed off-label to elderly dementia patients.

The public warning came nearly two years after the drug maker privately alerted the FDA that there was a problem with Risperdal, agency officials said in response to questions from Knight Ridder. It came six months after drug regulators in Canada issued a similar warning and urged doctors in that country to reassess their use of Risperdal to treat dementia.

FDA officials, in a written statement, said it took several rounds of questions to the drug maker before they had enough evidence to have the drug company issue the warning. Johnson & Johnson, based in New Brunswick, N.J., had no comment.

Murphy and his family have sued the drug company, which in court filings denies any wrongdoing. His daughter, Robbie Murphy, said: "Our father has been taken away from us. Basically the last enjoyable times he could have with us are gone."

Cancer PHOBIA? I'd read the whole article folks.




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