Antidepressants to Get U.S. Warning on Suicide Risks

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Antidepressants to Get U.S. Warning on Suicide Risks

(May 2, 2007) -- Antidepressant drugs, including Wyeth's top-selling Effexor, need new warnings of the risks of suicidal thoughts and behavior among young adults, U.S. regulators said.

The Food and Drug Administration asked the makers of 36 antidepressants to extend an existing precaution for children and adolescents to cover people ages 18 to 24 when they first use the drugs, the agency said in a statement today. Wyeth, Eli Lilly & Co. and other drugmakers must revise their labels within 30 days.

Sales of antidepressants fell after the warning about risks in children and adolescents was added in 2005. The FDA said today that scientific data hasn't shown an increased danger in adults older than 24, although consumer groups have urged the agency to broaden the warnings.

``What is magic about the cutoff of 24?'' said Sidney Wolfe, director of health research at Public Citizen in Washington, in a telephone interview. ``It doesn't make sense to pretend that the problem goes away once you get older.''

Americans spent $13.5 billion on antidepressants last year, according to data compiled by IMS Health Inc., a research firm in Fairfield, Connecticut. The medicines include Forest Laboratories Inc.'s Lexapro, Lilly's Cymbalta and Pfizer Inc.'s Zoloft.

People currently taking prescription antidepressants should continue to use them and consult their doctors if they have concerns, the FDA said. Depression and other psychiatric disorders, not medicines, are the most important causes of suicide, the agency's proposed warning emphasizes.

`Risk is Small'

``The risk is quite small,'' said Thomas Laughren, director of the FDA's psychiatric products division, on a conference call today. Studies found that taking antidepressants caused an additional 14 out of every 1,000 patients under age 18 to have suicidal thoughts or behavior, he said. About five in every 1,000 patients ages 18 to 24 had an increased risk.

The FDA's action follows an advisory panel's recommendation in December that the drugs' prescribing information be revised to inform doctors and patients about suicide risks seen in the trials of young adults during their initial months of treatment. It's not clear whether there's a long-term risk, the FDA said.

About 16 million Americans take antidepressants each month, according to the American Psychiatric Association. The group represents psychiatrists and has argued against stronger warning labels for children and adults.

Some researchers have said the strict ``black-box'' warning about suicide risk should be eliminated because it discourages the use of antidepressants in young people, even though these drugs have been shown to alleviate potentially dangerous symptoms of depression.

Increase in Youth Suicides

The decline in prescribing antidepressants coincided with an increase in youth suicides reported by the U.S. Centers for Disease Control and Prevention. This trend ``is a concern'' and will continued to be monitored by the FDA, Laughren said.

The revised precaution says anyone considering using an antidepressant should ``balance this risk with the clinical need'' for medication.

``We are encouraged that the agency has accompanied the warnings with balanced information about the importance of being treated for depression,'' said Tammy Hull, a spokeswoman for Indianapolis-based Lilly, in an e-mailed statement. ``This step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions.''

The proposed labeling change will ``preserve antidepressants as a valuable treatment option,'' said Gwen Fisher, a spokeswoman for Madison, New Jersey-based Wyeth. The drugmaker found no increased risk of suicide in its studies of Effexor in adults.

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Shreya Prudlo, a spokeswoman for New York-based Pfizer, also said there has been ``no established causal link'' between Zoloft and suicide in any age group. Forest, based in New York, is reviewing the FDA's request, according to spokesman Charles Triano.

By: Catherine Larkin
Source: Bloomberg

Read Dr. Harry Croft's New FDA Warning on Antidepressants: What Does It Mean to the Depression Patient?

Last updated: 05/07

Antidepressants to Get U.S. Warning on Suicide Risks

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