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Panel Wants Broader Antidepressant Labeling

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The New York Times
December 14, 2006
By BENEDICT CAREY

SILVER SPRING, Md., Dec. 13 — Strong warning labels about the suicide risk associated with antidepressants, which now include children and adolescents, should be extended to adults under 25, a federal advisory panel concluded Wednesday.

The panel, which voted 6 to 2 to recommend the warnings after a daylong hearing, also advised the Food and Drug Administration to require including information in the drugs’ labels highlighting the risks of untreated depression.

Since 2004, antidepressants have carried black-box warnings — the strongest the F.D.A. can require — about the risk of suicidal thinking and behavior for children and adolescents. The warnings appear in bold type set off by black borders, usually at the top of the prescribing information provided by drug makers to doctors and patients.

“I really feel we have an obligation to warn the public when we have new information, and we do,” said Jean Bronstein, a consumer representative and panel member from Sunnyvale, Calif., referring to a recent F.D.A. analysis that found a link between suicidal behavior and antidepressants in young adults, but not in older people.

The recommendation followed hours of emotional public testimony on both sides of the issue, and comes amid a long-running debate about the safety of the drugs, which include medications like Prozac, from Eli Lilly, Paxil, from GlaxoSmithKline, and Effexor, from Wyeth.

Some psychiatrists said expanded warnings could lead to more suicides. Dr. Carolyn B. Robinowitz, president-elect of the American Psychiatric Association, said the labels might cause a “black-box panic.”
“We’re talking about a devastating, chronic and recurrent disorder, and a black-box warning may serve as another barrier to care that people need,” Dr. Robinowitz said.

But other psychiatrists said the labeling might make doctors be more cautious about how they prescribe the drugs, reserving them for patients who are seriously depressed.

The panel also heard from many patients and family members who told stories of devastating loss. One woman said her niece set herself on fire and died just after having stopped the drug Effexor. Another woman, shaking, her daughter at her side, described how her 44-year-old husband had shot himself while he was on Paxil, and said, “I hold you responsible for this and always will,” pointing at the panel members.

Other patients, however, said they had done well on the drugs.

The panel based its decision in part on a recently completed analysis by F.D.A scientists of data from studies involving about 100,000 patients. Men and women under 25 who took the drugs were twice as likely as those given placebo pills to attempt suicide or prepare for a suicide attempt, the analysis found.

For every 1,000 patients given the drugs, about 4 will act on suicidal urges who would not have done so had they not been taking the medications, the analysis suggested.

“It’s about as unequivocal a result as you can get,” said Dr. Marc Stone, a senior F.D.A. reviewer and an author of the report. The analysis found that the drugs did not increase the risk of suicide in adults from 25 to 65, and significantly lowered suicide risk in people over 65.

The F.D.A. does not have to follow the recommendations of its advisory panels but usually does, and did so after a panel recommended similar warnings for minors in 2004. Since then, researchers have found that antidepressant prescription rates to children and adolescents have dropped in the United States and elsewhere. And the Centers for Disease Control and Prevention said last week that suicide rates in teenagers increased slightly in 2004, for the first time in more than a decade.

Several psychiatric researchers at the hearing argued that these trends suggested, in effect, that the agency’s previous warning for children had led to the deaths of people who were scared away from treatment.

“I recommend that the committee reverse its previous warning for children and adolescents and instead encourage careful monitoring” of side effects, said Dr. John Mann, a professor of psychiatry and radiology at Columbia University and director of psychiatric research at the New York State Psychiatric Institute.

But others said extending the warnings to include young adults was essential so patients could make informed choices.

“Had my son been told about this risk, had any of us been told, we wouldn’t be here,” said Jayne Richner, whose 22-year-old son, Sean, hanged himself in August just after he stopped taking the antidepressant Celexa. “It’s only been four months since he killed himself, and we’re still trying figure out how to get through every day because of this.”

Some former patients said the drugs had saved their lives. The apparently stark contradictions in the testimony and in studies might suggest the drugs increase suicidal urges in some and reduce them in others.

“It’s possible for a drug to opposite effects over time, even within same domain,” said Dr. Thomas Laughren, director of the division of psychiatry products at the F.D.A.



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