FDA expects its review of data on suicidal behavior in adults on antidepressants will take at least a year to complete.

The agency has asked antidepressant manufacturers to review controlled trials of the products for occurrences of suicidality in adult patients.

"The FDA has asked these manufacturers to identify all placebo-controlled trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA," the agency said in a June 30 ¹ Public Health Advisory.

"It is expected that this review will require a year or more to complete because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality."

Sponsors are being asked to review adult antidepressant data and classify potential suicide-related events employing a similar approach to that used to analyze pediatric antidepressant data.

Anti-epileptic drug manufacturers are also reviewing data for occurrences of suicidality following an FDA request (² Also see "FDA Requests Suicidality Event Review For Epilepsy Drugs" - Pink Sheet, 22 April, 2005.).

FDA said it began its review of suicidality in adults taking antidepressants prior to reports in "several recent scientific publications" that suggested an increased risk for adult patients taking the drugs.

All antidepressant manufacturers added a "black box" warning and other language on an increased risk for suicidality in pediatric patients to product labeling earlier this year (³ Also see "Antidepressant MedGuide Distribution Imminent; Unit-Of-Use Packs To Follow" - Pink Sheet, 4 March, 2005.).

Labeling language added to describe the increased rate of pediatric suicidality also includes some discussion of adult patients.

"Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality especially during the initial few months of a course of drug therapy, or at times of dose change, either increases or decreases," antidepressant class labeling states.

FDA's existing healthcare professional and patient information sheets on 11 antidepressants will be updated to include the label information on monitoring adult patients for suicidality "within the week," the agency said.

- Elizabeth Walker

FDA Requests Adult Antidepressant Suicidality Data

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