FDA Updates Analysis of Prozac in Children

August 19, 2004

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The Food and Drug Administration (FDA) has issued an update of its previous analysis of a possible link between some anti-depressant medication used by children and suicidal tendencies. The agency said it is preparing to issue new warnings.

"FDA has completed a new analysis of pediatric suicidality (suicidal thoughts and actions) data submitted to the agency and will be posting its analysis on its web site. FDA will also be posting on its web site additional summaries of pediatric efficacy studies from drugs that have been studied in depression in pediatric patients. Although specific new labeling language has yet to be developed, FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these studies and analyses," the agency said in a news release.

The update may alarm some parents whose children are on anti-depressants, especially since FDA was not specific about which medications may be the subject of the warning.

In 2003 British health authorities published a list of commonly prescribed anti-depressants that might increase the risk of suicidal behavior in young people, and declared only Prozac as suitable for children.

FDA says it has been closely reviewing the results of antidepressant studies in children since June 2003, after an initial report on studies with paroxetine (Paxil) appeared to suggest an increased risk of suicidal thoughts and actions in the children given Paxil, compared to those given placebo. Later reports on studies of other drugs supported the possibility of an increased risk of suicidal thoughts and actions in children taking these drugs. There were no suicides in any of the trials.

In mid September, the agency said, FDA officials will be discuss this issue at a public meeting of its Psychopharmacologic Drugs and Pediatric Advisory Committees, at which time the agency will hear from the public and solicit the advice of the committees on these labeling changes and other possible regulatory actions.

Earlier this year the FDA urged medical professionals to closely monitor patients of all ages for warning signs of suicide, especially when they first start the pills or change a dose. Researchers believe starting medication may cause agitation, anxiety and hostility in some patients who may be sensitive to rare side effects.

Doctors say it's hard to tell if medication triggers suicide or if it's a product of the depression the medication is designed to treat. So far, Prozac is the only FDA-approved drug for pediatric depression.

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