US FDA acknowledges doubts on antidepressant use

20 August 2004 19:25  [Source: ICIS news]

WASHINGTON (CNI)--The US Food and Drug Administration (FDA) said Friday that it will update its labeling requirements to reflect mounting evidence concerning the effect of antidepressants on suicidal tendencies in children.

 

FDA issued an analysis on the issue today.  Medical researchers have accused the agency of acting slowly and ignoring multiple studies linking the drugs to suicidal tendencies in children and teens. British regulators have advised doctors to refrain from prescribing antidepressants to young people.

 

Despite an agreement between drug makers and the agency to add general warning labels regarding the need to monitor patients for worsening depression, requirements for specific labeling language have yet to be developed. But FDA officials said the agency “will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these studies and analysis.” FDA also said it will post its new analysis and summaries of additional drug studies on depressed children on its Internet Web site

 

An FDA advisory committee will discuss the latest findings at a public hearing on 13 September. Congressional committees also may call hearings next month to investigate the latest findings and FDA policy.

 

The advisory committee meeting in September also will evaluate a recent Columbia University study. FDA had asked the New York City university to assemble an international panel to review definitions for suicidal tendencies.

 

“While there are findings among these data suggestive of an increased risk of suicidality for some of these drugs, there remain inconsistencies in the results,” FDA said in a statement, “both across trials for individual drugs and across drugs. Thus, an overall interpretation of these findings represents a substantial challenge.”

 

Antidepressant drugs are some of the pharmaceutical industry’s best-selling and most lucrative products. FDA said its main challenge next month will be to identify which, if not all, of the nine drugs on the market are linked to the increased risks.

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