EMEA advises against prescribing of antidepressants in children
pharmafile | April 28, 2005 | News story | Sales and Marketing |Â Â Â
Doctors across Europe will be discouraged from prescribing most modern antidepressants for children and adolescents following new EMEA advice.
Investigations into the safety and efficacy of the drugs by the UK and US regulators in 2004 showed the drugs were generally ineffective in treating depression in under-18s and significantly raised the risk of suicidality and hostility.
The regulator's Committee for Medicinal Products for Human Use (CHMP) produced the new recommendations, which have been expected for some time following a reappraisal of clinical trial evidence for the drugs.
Doctors and parents will be advised that SSRIs such as GlaxoSmithKline's Seroxat (paroxetine) and Wyeth's Efexor (an SNRI) should not be prescribed for children and adolescents except in their approved indications.
Just one SSRI is licensed in Europe to treat depression in children – fluoxetine (formerly Lilly's Prozac) – although some of the other drugs are licensed for obsessive compulsive disorder, and one of them for attention deficit/hyperactivity disorder.
The Commission is expected to follow the advice and make an announcement within 90 days, after which the guidelines will be implemented throughout Europe.
Despite the heightened warning, the EMEA has not issued a ban on the drugs' use, and has indicated doctors will be able to use them in the most serious cases. The regulator says doctors can use their clinical judgement to prescribe the drugs, but says patients should be carefully monitored for the side-effects, particularly at the beginning of treatment.
The EMEA said it would release details of the evidence once the recommendation is finalised by the European Commission.
In the UK, NICE is currently carrying out an appraisal of antidepressants in children and adolescents and will announce its final guidance in August this year.
