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. Forum: Join a Discussion on Mental Health and Treatment



Food and Drug Administration

Drugs (Pharmaceuticals)

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Labels on Antidepressants Sought to Warn of Suicide Risk

Published: March 22, 2004

(Page 2 of 2)

While suicide is already mentioned in a rarely read portion of a sheet included with prescriptions for the antidepressants, the new discussion of suicide will be placed in the drug's warning section, the most important, widely read and prominent section of the label. To further ensure that doctors will read the material, part of it will be in boldface. The label is the primary way the F.D.A. communicates with physicians about the safety and efficacy of drugs.


Jennifer Yoder, a spokeswoman for Lilly, said the company would comply with the agency's request.

"It's important that patients keep today's announcement from the F.D.A. in perspective," Ms. Yoder said. "Depression is a serious public health issue, and it takes great courage for patients to begin treatment in the first place."

Dr. Catherine Clary, a Pfizer vice president, said the company would work closely with the agency to come up with label changes for Zoloft. A spokeswoman for GlaxoSmithKline, the maker of Paxil, said the company was studying the request. The companies are almost certain to adopt the agency's proposed changes.

While the F.D.A. does not have the power to require the changes, if the manufacturers refuse to go along, the agency can declare their drugs mislabeled and force their removal. Because every antidepressant introduced in the past 15 years is included in the warning, no company is at a disadvantage. Indeed, even drugs like the GlaxoSmithKline antidepressant Wellbutrin, also known as Zyban, that have not been linked with suicide were included.

The drugs in the warning are: Prozac; Zoloft; Paxil; Wellbutrin; Luvox, from Solvay; Celexa and Lexapro, from Forest Laboratories Inc.; Effexor, from Wyeth; Serzone, from Bristol-Myers Squibb; and Remeron, from by Akzo Nobel.

The dispute about whether popular antidepressants cause some patients to become suicidal or violent has been continuing for 14 years. In 1990, a Harvard psychiatrist wrote a paper suggesting that some of his patients had become acutely suicidal after taking Prozac. More testimonials followed. But a 1991 scientific advisory panel concluded that there was no convincing evidence.

The studies in children raised the issue again last year, and health authorities in Britain told physicians that with the exception of Prozac, the drugs should not be used in teenagers or children. Still, studies show that teenage suicides have declined sharply in countries where antidepressant therapy has become widespread, suggesting that the drugs prevent many more deaths than they may cause.

Dr. Madhukar Trivedi, director of the mood disorders program at University of Texas Southwestern Medical School at Dallas, said he worried that the new warnings might make depressed patients afraid of their pills. "The consequences for not treating depression are very high," Dr. Trivedi said.

The agency advisory says: "Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression and suicidality, especially at the beginning of therapy or when the dose either increases or decreases."

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity and severe restlessness are also possible side effects, the advisory adds.

The agency decided against following British regulators in suggesting that physicians should avoid the drugs' use in children. Only Prozac has been shown to be effective in treating depression in children, but that does not mean the other drugs do not work, officials said.

"What we don't know for sure is what is the best thing to do for a child who's depressed," Dr. Temple of the F.D.A. said. "Depression has its own liabilities. It can be a fatal illness. What we don't know is whether the long-term benefits outweigh the risks."

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