By Jeremy Laurance, Health Editor
26 April 2005
Europe's drugs watchdog has banned Prozac and other modern antidepressants for under-18s because of safety fears, putting it on a collision course with Britain's drugs regulator.
Antidepressants increase suicidal thoughts and suicide attempts among children and adolescents, and should not be used to treat depression, the scientific panel of the European Medicines Agency (Emea) said. Including Prozac in the ban clashes with the stance taken by Britain's drugs regulator 16 months ago. Prozac is the only antidepressant that doctors can prescribe to children in Britain, following a safety review in 2003.
The drug was singled out by the UK Medicines and Healthcare Products Regulatory Authority (MHRA) as the only one of the modern generation of antidepressants that was effective and safe for children. All others were banned for children in December 2003.
Prozac is not licensed for treating depression in the UK but doctors are free to prescribe it provided they take personal responsibility for doing so.
It is licensed for treating children with depression in the US, but regulators there ordered last September that packs should carry the severest "black-box" warning after concluding that it could increase suicide risk. Until the UK ban was announced in December 2003, it is estimated up to 50,000 children were being treated with antidepressants in the UK. The review of the drugs by the MHRA and Emea was prompted by reports of suicides linked to Seroxat, the world's biggest-selling antidepressant, made by GlaxoSmithKline. Its use among children was banned in June 2003 after new information about its safety became available to the MHRA.
Emea said its review of all the drugs had revealed that suicide attempts and suicidal thoughts, aggression and anger were more common in clinical trials of children taking antidepressants, including Prozac, than in those taking a placebo. "The agency is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks. Doctors and parents will also be advised that these products should not be used in children and adolescents except in their approved indications." Approved indications include obsessive-compulsive disorder and attention deficit/ hyperactivity disorder, but do not include depression.
The recommendation of the agency's scientific panel must be ratified by the full Emea within three months, normally a rubber-stamping exercise. But a spokes-woman for the MHRA said that it would seek to change the recommendation. She said: "There is still time to influence it. We 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. The profession know they are going to have to prescribe something and it is important they know what the dangers are and the best way of prescribing it. We think it is safe to use so long as it is monitored carefully."
The MHRA's review of modern antidepressant drugs in treating adults concluded in December last year that they had been over-prescribed to hundreds of thousands with mild depression in whom the risk of side-effects outweighed the benefits.