Brussels, 07/06/2006 (Agence Europe) - The European Medicines Agency (EMEA) has adopted a positive opinion on the use of Prozac (fluoxetine) for the treatment of children and teenagers suffering from depression who do not respond to psychological therapy. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of using Prozac outweigh its potential risks but that the marketing authorisation holder, US company Eli Lilly, 'should carry out additional studies to ensure that the safety profile of Prozac remains acceptable'. The EMEA wants Prozac only to be used together with psychological therapy in patients not responding to psychological therapy alone after 4 to 6 sessions. The starting dose should be 10 mg per day (given as 2.5 ml of the oral solution) and may be increased to 20 mg per day after one to two weeks. If no clinical benefit is seen within 9 weeks, treatment should be reconsidered. The EMEA explains that the 'significance of the observations in animal studies on sexual development emotional behaviour and testicular toxicity will be further investigated', and Eli Lilly is required to set up 'a system to obtain safety data in treated children, in particular regarding sexual development.' The CHMP made its assessment following a request from France following alarming reports about increased suicide levels among children and teenagers treated with Prozac.