FDA Looks to Widen Antidepressant Warnings

Potential suicide risk would extend to 24-year-olds

WEDNESDAY, May 2, 2007 (HealthDay News) -- U.S. health officials recommended Wednesday that warnings about antidepressants and suicidal thoughts and behaviors be expanded to young adults up to 24 years of age.

Currently, the so-called "black box warnings" on antidepressants only cover children and teens.

The proposed label changes would note that studies have not found an increased suicide risk in adults older than 24, and people 65 and older have shown decreased risk of suicidality. The changes would also emphasize that depression and some other serious psychiatric disorders are the prime causes of suicide.

U.S. Food and Drug Administration officials sent out letters Wednesday to manufacturers of all antidepressants, asking them to update existing black box warnings. Specifically, the new labeling will include warnings about an increased risk of suicidal thoughts and behavior in young adults up to 24, especially during the first month or two of treatment.

"The risk is quite small, but we think it is a real risk and something we need to pay attention to," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, Center for Drug Evaluation and Research, said during a Wednesday teleconference.

The announcement is the latest in a string of FDA actions involving antidepressant use in children and young adults.

In 2004, the FDA directed antidepressant manufacturers to revise their labeling to include a black box warning alerting health-care providers to an increased risk of suicide and suicidal thoughts in children and teens.

That followed an FDA review of 24 placebo-controlled trials involving antidepressant medication in more than 4,400 children and adolescents. The finding: The medications spurred a twofold (4 percent vs. 2 percent) increased risk for suicidal behavior or thoughts, although no completed suicides were reported.

Wednesday's announcement is a follow-up to recommendations made in December by an FDA advisory committee.

Since the warnings first appeared three years ago, there has been a drop in the number of U.S. children being prescribed antidepressants and a subsequent increase in suicides, research has found.

This has prompted a different set of concerns.

"If you have a person who is very depressed, suicidal or could potentially become suicidal, the risk of not treating is much greater than the risk of treating," said Dr. Helen Zaphiris, assistant professor of psychiatry and behavioral science with the Texas A&M Health Science Center College of Medicine.

"There's a concern that there may be a change in practice patterns, especially with non-psychiatrists or family practitioners who don't have all the data in front of them. There needs to be more and more research, but, in the meantime, with careful monitoring, people need to be treated," Zaphiris said.

Laughren's remarks at Wednesday's teleconference prompted a flurry of questions about the impact of yet more labeling revisions.

"It would be speculation, but the coincidence of a decrease in prescribing and an increase in adolescent suicides after years of suicides coming down is a concern," Laughren said. "I don't disagree with that."

But he stopped short of predicting any future labeling changes.

"Labeling is dynamic, and we will continue to look at this issue over time," Laughren said. "We will certainly look at any new information we get later this year. I can't tell you at this point in time what our decision would be, but, clearly, it would be a factor."

In an unusual move, the new labels would also include language stating some of the benefits of antidepressants.

"The new language will also emphasize that depression and certain other psychiatric disorders are themselves the most important cause of suicide," Laughren said. "These drugs do have value across the age spectrum, but their use requires certain precautions. Any patients being treated, of whatever age, should be monitored appropriately."

Laughren added: "I never said [these drugs] shouldn't be used in children and adolescents, but, if used, they should be used cautiously. There was never any intent that this would decrease appropriate prescribing."

More information

To learn more, visit the FDA.

SOURCES: Helen Zaphiris, M.D., assistant professor of psychiatry and behavioral science, Texas A&M Health Science Center College of Medicine, and psychiatrist, Scott & White Hospital, Temple, Texas; May 2, 2007, teleconference with Thomas Laughren, M.D., director, Division of Psychiatry Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.
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