Youth Antidepressant Warnings Had Desired Effect

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Youth Antidepressant Warnings Had Desired Effect

(January 7, 2008) - NEW YORK, -- Despite concerns that those of all ages would be put at risk, FDA warnings about treating patients six to 17 with antidepressants appear to have hit the mark, researchers here said.

Changes in treatment patterns after black box warnings were "modest in size" and greatest among young patients, according to Mark Olfson, M.D., of Columbia University here, and colleagues.

Action Points

Explain to interested patients that the FDA has issued warnings that antidepressant use in young people has the risk of increased suicidal behavior.

Note that some authorities worried that the warning might prevent some patients from seeking therapy.

Explain that the current study appears to show those fears were unfounded.

But the warnings appeared to slow the growth in the use of all types of antidepressants in all age groups, the researchers reported in the January issue of Archives of General Psychiatry.

The FDA warned in June 2003 that paroxetine (Paxil) shouldn't be used in young people because of a potentially increased risk of suicidal behavior. That was followed in October 2004 with a black box warning on all antidepressants for youth.

Mental health organizations -- including the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry -- were critical of the warnings, saying they could frighten depressed individuals into not seeking treatment.

But that appears not to have happened in general, Dr. Olfson and colleagues found.

Instead, the first warning caused a significant decline (P<0.001) in the use of paroxetine among young people, but little change in its use among other age groups.

The warning also had no significant effect on the rate of use of other antidepressants, the researchers found, although the rate of increase in their use slowed significantly (P<0.001).

The second warning resulted in nonsignificant yearly declines in the use of all antidepressants among young people, the researchers said.

The Columbia data were derived from the records of Medco Health Solutions, the largest pharmacy benefits company.

The researchers examined prescription records of patients for three periods -- the "pre-warning" period from May 1, 2002 to June 19, 2003, the "paroxetine warning" period from June 20, 2003 to Oct. 15, 2004, and the "black box warning" period from Oct. 16, 2004 to Dec. 31, 2005.

Each study period contained records of more than two million randomly chosen patients who were eligible for antidepressants, irrespective of whether they filled a prescription.

During the pre-warning period, Dr. Olfson and colleagues said, the yearly increase in antidepressant use among young people was 36%, which was followed by nonsignificant declines of 0.8% and 9.6% per year during the paroxetine and black box warning periods.

Before the first warning, paroxetine use among young people was also increasing at 30% per year, which was significant at P<0.001. But it dropped by 44.2% per year during the paroxetine warning period, which was also significant at P<0.001.

There was little additional change in paroxetine use after the second warning, the researchers said.

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In adults, changes in antidepressant use were "less pronounced," the researchers said, although for adults 65 and older, overall antidepressant use increased 8.1% per year during the black box study period, an increase that was significant at P<0.001.

The study is "reassuring," Dr. Olfson and colleagues said, although it has a number of limitations. One problem is that the regulatory changes came very quickly, they said, so that it's difficult to disentangle the effects of each change from other influences.

Also, the researchers noted, the study may not represent the general U.S. population, although it was based on a random sample drawn from about 60 million patients.

The research was supported by the Agency for Healthcare Research and Quality and the Carmel Hill Fund. Data were provided by Medco Health Solutions.

Dr. Olfson reported financial links with Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Pfizer, McNeil, and Janssen.

By Michael Smith, North American Correspondent, MedPage Today Published: January 07, 2008 Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.

Primary source: Archives Of General Psychiatry

Last updated: 01/08

Youth Antidepressant Warnings Had Desired Effect

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