Pending weight loss pill is linked to suicide risk
WASHINGTON - The maker of a weight loss drug awaiting federal approval suggested Wednesday that prospective users be screened for depression, seeking to limit damage from a finding that the medication increases the risk of suicidal behavior.
In studies, patients given the once-daily tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, as those who received a placebo, Dr. Amy Egan, a Food and Drug Administration medical officer, told federal health advisers.
"The numbers of events are small, but in aggregate they are worrisome," Egan said.
Officials from Sanofi-Aventis SA, the manufacturer of the drug, suggested patients be screened for depression before they are prescribed the drug, rimonabant. They also advised that patients visit their doctors five times during the first year of treatment to be reassessed.
The drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who has been diagnosed with depression or is taking antidepressant medication, Sanofi-Aventis' Richard Gural told the panel of advisers.
The FDA is expected to decide by July 27 whether to allow the drug on the market. The company proposes selling it under the brand name Zimulti. Rimonabant already is sold in Europe as Acomplia.
The findings make it highly likely the first-in-its-class drug would bear stern warnings if it is approved. Company officials embraced the idea of such warnings, which could exclude FDA-approved use in some patients.
Zimulti, when used in conjunction with a modest calorie diet and physical exercise, significantly decreases body weight and waist circumference in overweight or obese patients, according to Sanofi-Aventis. In yearlong studies, patients on the drug lost roughly 14 pounds. Those given dummy pills lost about 4 pounds. Patients regained weight when treatment was stopped after a year, the company said.
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