A panel of experts told the Food and Drug Administration on Friday that there is no sound evidence to conclude that Prozac or any other antidepressant causes suicides or other violent behavior.
The scientists said they were moved by the many stories they heard earlier in the day about suicides and other violence committed by people taking Prozac, but they voted 6 to 3 to recommend against any label changes for antidepressant drugs.
A vote rejecting a link between antidepressants and violent behavior was unanimous.
Panel members expressed concern about the kind of care that was being given to the patients who end up trying to commit suicide or other violent acts, but they concluded that labeling was not the way to educate doctors.
Other panel members said more information was needed, especially on antidepressants that have been on the market for decades, as well as on newer drugs.
“It’s hard to say there’s much evidence,” said Dr. Jeffrey Lieberman, a member of the advisory panel. But he said the anecdotes are “hard to ignore.”
Prozac, made by Eli Lilly & Co. of Indianapolis, has been prescribed to more than 3 million patients in the United States and 5 million people worldwide.
One former Prozac user, Nedra Walnum, a 32-year-old San Diego woman who said she attempted suicide after taking the antidepressant, urged the panel to “please remove this killer drug from the market before any more people are killed.”
Robin Schott of Denton, Md., held up her arms to show the scars on her wrists that marked her suicide attempt seven days after she stopped taking Prozac.
“Yes, it’s an anecdote,” she told panel members. “But I want you to be aware of what’s going on in the real live world.”
Other witnesses told of sons and daughters who had taken their lives after taking the drug, and of people fatally shooting themselves in front of their children.
But psychiatrists and other mental health professionals told members of the panel that the tragedies amounted only to anecdotes, not scientific evidence that Prozac, rather than depression itself, sparked the violent behavior.
John A. Smith, deputy executive director of the National Mental Health Assn., noted that depression can be a lethal disease if left untreated. Fifteen percent of untreated depressed patients commit suicide, he said.
The FDA has received at least 14,100 reports of adverse reactions from Prozac since it was introduced on the market in 1987.