EU calls for tougher warnings on antidepressants for kids

Apr 25 2005

A committee of experts in Europe are calling for strong warnings to be placed 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 Prozac-type serotonin-selective reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) were associated with increased suicide-related behaviour and hostility in young people.

The London-based watchdog says they are recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks and will advise doctors and parents that these products should not be used in children and adolescents except in their approved indications.

This action is the latest indication of a worldwide clampdown on the use of Prozac-type pills in teenagers after research has produced evidence that the drugs can lead to an increased incidence of suicide attempts, suicidal thoughts and anger.

For the most part the drugs were initially approved for only treating adults in the European Union, but doctors have sometimes used them "off-label" in children. A few of the products are licensed for paediatric 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.

Martin Harvey, an agency spokesman says the new warnings would not prevent the use of these medicines in such approved settings.

No sign of a link to suicide-related behaviour and the use of Strattera, has been established says the agency but experts concluded the drug should carry a warning reflecting an increased risk of side-effects such as hostility.

Other medicines 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 medicines from Lilly, Cymbalta and Prozac.