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EMEA seeks SSRI warning

The European Medicines Agency (EMEA) has all but banned the use of two popular classes of antidepressants in children.

The European Medicines Agency (EMEA) has all but banned the use of two popular classes of antidepressants in children, recommending that strong warnings be issued to doctors and parents against their use.

In a review of serotonin-selective reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) medicines, the agency's expert scientific committee, the Committee for Medicinal Products for Human Use, concluded that both types of drug were associated with increased risks of suicide and hostility in young people.

ìSuicide-related behaviour and hostility were more frequently observed in clinical trials among children and adolescents treated with these antidepressants compared to those treated with a placebo,î the Agency said in a statement. ìThe 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.î

It also said that doctors and parents would be advised that the drugs, which include Eli Lilly's Prozac and GlaxoSmithKline's Seroxat, should not be used in children and adolescents ìexcept in their approved indicationsî.

Approved indications include obsessive-compulsive disorder and attention deficit - hyperactivity disorder, but do not include depression.

The recommendation, which must be fully ratified by the Agency within three months, goes against advice given out by the British regulator, the Medicines and Healthcare products Regulatory Authority (MHRA).

Although the MHRA banned most modern antidepressants for children in December 2003, it made an exception for Prozac, saying it is safe and effective. While the drug is not licensed for treating depression in the UK, doctors are free to prescribe it provided they take responsibility for having done so.

ìWe back what EMEA's scientific panel is saying but the key difference is that Prozac is the one drug for which there is clinical trial evidence that it is effective,î said a MHRA spokeswoman. ìWe think it is safe to use as long as it is monitored carefully.î

Until the UK ban, it is estimated that up to 50,000 British children were being treated with antidepressants. Other medicines covered by the EMEA review included other Lilly products Cymbalta and Strattera, Lundbeck's Celexa and Lexapro, Pfizer's Zoloft, Wyeth's Effexor and Akzo Nobel's Remeron.

30th September 2008

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