Prozac can be prescribed for depressed children as young as eight – but only if they are also having psychological therapy, the European drugs regulator has ruled.
Up to now Prozac – known also as fluoxetine – has been widely prescribed without a licence, or “off label”, to under 18s in the UK.
But the European Medicines Agency has now licensed Prozac throughout the European Union to children aged 8 years or older who have moderate to severe depression.
However, the agency’s Committee For Medicinal Products For Human Use (CHMP) concluded that while the benefits of using Prozac for children outweighs its risks, the drug’s manufacturers, Eli Lilly, should carry out further studies to ensure the safety of Prozac.
The CHMP also ruled that doctors should only prescribe Prozac for children if they are also having psychological therapy, and only if they have also not responded to such therapy after four to six sessions.
If Prozac shows no clinical benefit within nine weeks, then treatment should be “reconsidered”, ruled the CHMP.
Doctors and parents should also carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of Prozac treatment, said the CHMP.
Prozac is the only antidepressant of the selective serotonin reuptake inhibitor (SSRI) class which the UK drugs regulatory body, the Medicines and Healthcare Products Regulatory Agency has exempted from a ban on use in under 18s, due to increased suicide risk.