FDA Shouldn't Approve Diet Drug, Panel Says

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"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 use, many consumers may take the medication for many years, Wolfe said.

But Nonas said that as with the use of any drug, patients need to be monitored for possible side effects.

"You do what we do with any new medication, you give it to your patient, and you bring them back for monitoring to make sure that it is working the way it should be working," Nonas said.

While patients need to be watched for depression, Nonas said, she doesn't think a "black box" warning is necessary. "A black box warning would be needed if people were committing suicide, but that's not the case," she said.

The FDA is expected to decide by July 27 whether the drug should be on the market. If approved, the drug would be sold in the United States under the name Zimulti. In Europe, it is sold under the brand name Acomplia.

Last year, the FDA decided not to approve rimonabant as an aid to stop smoking.