The U.S. Food and Drug Administration said last week that it has completed a new analysis of data regarding antidepressants and suicidal tendencies in children.
The FDA said the new data may warrant new warnings labels for antidepressants.
“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 FDA said in a memo posted on its web site.
The FDA said it has been closely reviewing the results of antidepressant studies in children since June 2003, after an initial report appeared to suggest that children taking the antidepressant Paxil had an increased risk of suicidal tendencies, compared to those given placebos. 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, the FDA said.
The agency has scheduled a public meeting in Bethesda, Maryland on September 13 and 14, of its Psychopharmacologic Drugs and Pediatric Advisory Committees, at which time the agency said it will hear from the public and solicit the advice of the committees on these labeling changes and other possible regulatory actions.
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