Prozac & therapy OK for Europe kids.
"Prozac should only be used together with psychological therapy in patients not responding to such therapy alone after four to six sessions," said the EMEA in its recommendation to the European commission, which will formally grant the license. If the child does not get better in nine weeks, the drug treatment should be reconsidered.
Prozac, or fluoxetine, was developed by Eli Lilly and Co. and is now widely available in generic versions. It is one of a class of drugs known as Selective Serotonin Reuptake Inhibitors.
Research suggests that some SSRIs are associated with an increased risk of suicidal behaviour and thoughts. The agency found that the benefits outweighed the risks in children with moderate to severe depression who failed to respond to psychological therapy. The move is unprecedented, according to Tim Kendall, joint director of the National Collaborating Centre for Mental Health, which formulated Britain's guidelines on the treatment of depression in children. "This is the first time to my knowledge that a drug has been given a license which includes a period of psychological treatment before and during the drug treatment," he said.
Prozac is the only anti-depressant of the SSRI class that has been exempted from the general ban on use in children. Analysis of trial data has shown that the risk of children becoming suicidal on other SSRIs is greater than the benefit they get from taking the drugs.
The agency ruled that to start, a 10mg daily dose of Prozac could be taken and increased to 20mg per day after one to two weeks. The agency stressed that doctors and parents should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of treatment. A system will be put in place to obtain safety data on use of the drug in children, in particular whether there is any impact on sexual development.
Mental health campaigners said it was vital that any use of the drug in children was closely monitored.
Eli Lilly has also been instructed by the EMEA to "carry out additional studies to ensure that the safety profile of Prozac remains acceptable." The agency also wants further investigation of findings in the early animal safety studies on sexual development, emotional behaviour and testicular toxicity.