- The Washington Times - Wednesday, May 2, 2007

Young adults beginning treatment for depression should be warned about increased risks of suicidal tendencies, federal health officials said yesterday.

The Food and Drug Administration has new data showing 18- to 24-year-olds taking antidepressant drugs are experiencing a “slight increase” in suicidal thinking and behavior. As a result, the agency yesterday sent letters to all manufacturers of antidepressant medications asking them to update current suicide warnings for children and teens to include such warnings for young adults.

“We fully expect all the companies to adopt this language,” said Thomas Laughren, director of the FDA’s psychiatric products division. “Ultimately, they don’t have any choice, and they should want to.”

Every drug company that makes an antidepressant is being asked to include new warnings to young adults within 30 days. Popular antidepressants that will be affected include Lexapro, made by Forest Laboratories Inc.; Paxil, made by GlaxoSmithKline PLC; Prozac, made by Eli Lilly and Co.; and Zoloft, made by Pfizer Inc.

About 16 million Americans take antidepressants, according to the American Psychiatric Association.

The first set of warning labels on antidepressant drugs appeared in 2004, in the form of a “black box” warning. Such a warning, named for the black border that usually surrounds the text, means that medical studies indicate the drug carries a significant risk of serious or life-threatening side effects.

The initial warnings were aimed at children and adolescents. But the FDA then began a comprehensive review of 295 antidepressant trials that included more than 77,000 adult patients with severe psychiatric disorders.

Dr. Laughren said the new data show that out of 1,000 patients taking both an antidepressant and a placebo drug, five patients taking the actual drug showed signs of suicidal behavior.

“The risk is quite small,” said Dr. Laughren, but added that the data are significant enough to ask for new warning labels.

He said the new data also revealed an increase in suicidal behavior among patients younger than 18. There is a decrease in suicidal thinking among patients 65 and older.

The suicide rate rose more than 18 percent in patients 19 and younger in 2004, according to the Centers for Disease Control and Prevention. A 12 percent increase in suicides occurred in 15- to 19-year-olds during the same year.

The increase in suicides occurred at the same time, in 2004 and 2005, that the FDA mandated heightened warnings on the labels of a particular class of antidepressant medications that includes Prozac, Paxil and Zoloft. That connection prompted some mental health professionals to question the FDA’s decision to place a suicide warning label on the drugs because it may discourage use of the drugs that would benefit depressed people.

Antidepressant prescriptions by pediatricians dropped by about 10 percent in 2004, according to the American Academy of Child and Adolescent Psychiatry.

Mental Health America, a nonprofit organization representing mentally ill people, lauded the FDA’s move but requested the agency review the warning label’s effect on suicide rates.

“The FDA clearly heard the concerns of consumers, family members and mental health professionals and included vital information about the inherent risk of suicide in untreated depression,” said David Shern, president of Mental Health America. “However, Mental Health America continues to encourage the agency to conduct an analysis of the impact of the black box label originally put in place in 2004 on rates of identification and treatment of depression and incidence of suicide.”

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