EU agency wants tough antidepressant youth warning

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Europe’s medicine regulator has called for strong warnings on two classes of antidepressants, informing doctors and parents of the risk they could pose to children and adolescents.

A European Medicines Agency expert committee concluded that serotonin-selective reuptake inhibitors (SSRI), such as Prozac, and serotonin-norepinephrine reuptake inhibitors (SNRI) were associated with increased suicide-related behavior and hostility in young people.

“The agency’s committee is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks,” the London-based watchdog said in a statement Monday.

"Doctors and parents will also be advised that these products should not be used in children and adolescents except in their approved indications.”

The action is the latest sign of a worldwide clampdown on the use of Prozac-type drugs in teenagers, following evidence that the drugs can lead to an increased rate of suicide attempts, suicidal thoughts and hostility.

Most of the drugs are only approved for treating adults in the European Union, but doctors have sometimes used them “off-label” in children. A few of the products are, however, licensed for pediatric use in treating obsessive-compulsive disorder and one of them, Eli Lilly and Co.’s Strattera, is approved for the treatment of attention deficit hyperactivity disorder.

Agency spokesman Martin Harvey said the new warnings would not prevent the use of these medicines in such approved settings.

In the case of Strattera, the agency said there was no sign of a link to suicide-related behavior but experts concluded the drug should carry a warning reflecting an increased risk of side effects such as hostility.

Other drugs covered by the European review included GlaxoSmithKline Plc’s Paxil, or Seroxat; Lundbeck’s two drugs Celexa and Lexapro; Pfizer Inc’s Zoloft; Wyeth’s Effexor; Akzo Nobel’s Remeron; and two other drugs from Lilly, Cymbalta and Prozac. 

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