FDA Talk Paper
August 20, 2004
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As part of its commitment to keep the American public fully informed about the status of its review of data concerning the use of antidepressants in pediatric patients, the Food and Drug Administration (FDA) is issuing this update to provide health care providers and patients with the most current information on this topic.
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.
Next month, on September 13 and 14, 2004, FDA officials will be discussing 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.
FDA 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.
FDA has closely examined the studies of the antidepressants because of the potential public health impact of a link between the drugs and suicidality and the importance of these drugs in treating depression and other serious mental health conditions. On close examination of the initial reports of suicidality, it was unclear whether some of the identified suicidal behaviors reported in these studies represented actual suicide attempts or self-injurious behavior that was not suicide-related. FDA therefore arranged with Columbia University suicidality experts to review these reports.
Meanwhile, FDA brought the available information to its Psychopharmacologic Drugs Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees on February 2, 2004. The advisory committee members advised FDA that even before the Columbia analysis was complete, the labeling should draw more attention to the need to monitor patients closely when antidepressant therapy is initiated. Based on this recommendation, FDA asked manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for worsening of depression and the emergence of suicidality, whether such worsening represents an adverse effect of the drug or failure of the drug to prevent such worsening. The new warning language has now been added to the labels for seven of these products. Sponsors for the other three drugs have agreed to adopt the language.