FDA Reviews Antidepressant Data

Pharmacy Times, Volume 0, 0

The FDA is taking steps to ensurethat patients and health care providersare aware of the possible increased riskof suicidal behavior in adults treatedwith antidepressants. The FDA's PublicHealth Advisory suggests the following:

  • Adults being treated with antidepressantmedicines should bewatched closely for signs of worseningdepression and for increasedsuicidal thinking orbehavior
  • Close observation of adults maybe vital when antidepressant medicationsare started for the firsttime or when doses have changed
  • Adults whose symptoms worsenwhile being treated with antidepressantsshould be evaluated bytheir health care provider

Although the FDA issued the advisoryin response to recent studies indicatingthe risk, they had already initiatedthe process of reviewing data todetermine whether there is an increasedrisk of suicidal behavior inadults taking antidepressants. The FDAhas asked manufacturers to providedata from their trials, using anapproach similar to that used in theevaluation of the risk of suicidalbehavior in children taking antidepressants.This process involves hundredsof clinical trials and may takemore than a year to complete. TheFDA will continue to provide updatesas they become available. To view thePublic Health Advisory, visit www.fda.gov/cder/drug/advisory/SSRI200507.htm.