FDA to Require Warning Label For Antidepressants 

ANNA WILDE MATHEWS / Wall Street Journal 18oct04

[More about antidepressants]

Federal regulators soon will require labels on all antidepressants to carry a strong warning that the drugs increase the risk of suicidal thoughts and behaviors in young people.

The Food and Drug Administration's move to require a so-called black box label, in which a warning is surrounded by a black box, comes after more than a year of debate over the drugs' effects and the agency's handling of the issue, which drew congressional scrutiny that has now grown to focus more broadly on the agency. The FDA also will create an information guide that consumers will receive when they fill an antidepressant prescription, and will push for "unit of use" packaging so the document can be enclosed in the pill containers given to patients at pharmacies.

"Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them," said Lester M. Crawford, acting commissioner of the agency.

The new warning — which will apply to both the labels of new antidepressants and those of all older classes of the drugs — aims to provide the most-definitive answer to date to long-running questions about the effect of the drugs on children and teens. The new warning language will say that "antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents" with depression and other psychiatric disorders. It also will say that patients should be closely watched, and note whether the drug has shown enough evidence of efficacy to be approved for pediatric use. Only Prozac, made by Eli Lilly & Co. and available generically, has been approved to treat depression in young people.

The agency stopped short of pushing for a specific informed-consent form or procedure that doctors would have to share with parents or young patients before prescribing an antidepressant. FDA officials said they believed the black-box warning would prod doctors into such discussions even without a more-formal arrangement. The FDA's announcement closely matched the recommendation of an advisory committee in September.

The American Psychiatric Association, in a statement, said it had "deep concern that a 'black box' warning on antidepressants may have a chilling effect on appropriate prescribing for patients," which "would put seriously ill patients at grave risk."

The FDA's handling of growing concerns about antidepressants prompted congressional investigations into how the agency responded to an analysis by an FDA epidemiologist that found a link between antidepressants and suicidal tendencies in young people. He wasn't allowed to present that conclusion at an advisory committee meeting in February, though underlying data were offered. After outside reviewers resorted the data he had examined, the FDA made a similar finding.

Congress is closely watching the issue. The Senate Finance Committee has broadened its original inquiry to look at several other FDA matters, including concerns about Vioxx, the Merck & Co. arthritis drug that recently was withdrawn. Congress is also examining the production problems at Chiron Corp. that resulted in this season's current severe shortage of influenza vaccine.

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