"The unanimous 14-0 vote followed another unanimous vote by the panel that drugmaker Sanofi-Aventis had failed to prove the safety of its drug, the "

""There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, of The Rockfeller University."

"While the FDA isn't bound to follow the recommendations of its advisory panels, it typically does."

"Rimonabant has been touted by Sanofi-Aventis as a wonder drug that aids in weight loss and also helps people stop smoking, but the drug has been linked to increased risk of suicidal thoughts among some people who take it."

"This side effect has delayed FDA approval, and is, as Dr. Eric Colman, deputy director of the FDA's metabolic and endocrine drugs office, told the panelists Wednesday, "obviously, a big concern for us," the "

""Who is the right patient to receive rimonabant? Not everybody," Richard Gural, of Sanofi-Aventis, testified. The drug is not right for anyone with a history of depression or suicidal thoughts, or who has been diagnosed with depression or is currently taking antidepressant medication, he added, according to the "

"Gural suggested that patients be screened for depression before they were prescribed the drug. He also recommended that patients visit their doctors five times during the first year of treatment to be reassessed, the "

""Well-conducted, large clinical trials provide clear and compelling evidence that rimonabant facilitates weight loss," said Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. "Those same trials suggest the drug is safe and generally well-tolerated. In my opinion, there is ample evidence to support FDA approval of rimonabant at this time.""

""There have been a significant number of studies that have looked at the benefits versus the risks of rimonabant," said Cathy Nonas, director of the obesity and diabetes program at North General Hospital, in New York City. "With any medication, there are always possible side effects, but that doesn't mean that it's not going to be beneficial for many people.""

"But, the consumer advocacy group Public Citizen said it remains opposed to the drug's approval."

"In testimony prepared for the advisory committee, Dr. Sidney Wolfe, director of the organization's health research group, said, "The evidence for increased suicidal tendencies and depression is of particular concern for a drug targeted toward the obese, a population that has been shown to have a significantly higher incidence of depression and eating disorders compared to non-obese individuals.""

"Wolfe also pointed to what he called the paucity of information on the effect of using the drug over the long term. "

""Because rimonabant is the first drug of its class, there is no data on its use in humans over an extended period of time," he testified. Because people on rimonabant tended to regain weight after discontinuing
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