Prozac & therapy OK for Europe kids.Will there be enough qualified therapists? This is a question European mental health experts are asking. The question arises as the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.
Roughly parallel to the U.S. EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. , declared that Prozac can be prescribed for children as young as eight years. However, the drug should only be used in combination with on-going therapy, an unprecedented requirement for a drug approval.
"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 European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community , 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 fluoxetine /flu·ox·e·tine/ (floo-ok´se-ten) a selective serotonin reuptake inhibitor used as the hydrochloride salt in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder. , was developed by Eli Lilly Eli Lilly can refer to:
Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression.
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 SSRI selective serotonin reuptake inhibitor.
Selective serotonin reuptake inhibitor; a class of drugs that inhibit the reuptake of serotonin in the central nervous system, used to treat depression and other 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 testicular /tes·tic·u·lar/ (tes-tik´u-lar) pertaining to a testis.
Of or relating to a testicle or testis.
pertaining to the testis. toxicity.