EMEA approves Prozac for Children

June 14, 2006

The European Medicines Agency (EMEA) has approved the use of Prozac (fluoxetine) and other serotonin selective re-uptake inhibitor (SSRI) medicines to treat children

The European Medicines Agency (EMEA) has approved the use of Prozac (fluoxetine) and other serotonin selective re-uptake inhibitor (SSRI) medicines to treat children of 8 years and over 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 in this therapy area outweigh its potential risks, but added that the marketing authorization holder (MAH), Eli Lilly, should carry out additional studies to ensure that the safety profile of Prozac remains acceptable.

Prozac and other SSRIs are authorized in most EU Member States for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa in adults. Following a request from the UK, the MAH for Prozac submitted an application to extend the indications to include the treatment of major depressive episodes in children and adolescents. CHMP was asked by France to begin an arbitration review on the basis of unresolved safety and efficacy concerns.

Based on the data reviewed the CHMP found that the studies in children and adolescents were positive, but added that if no clinical benefit was observed within 9 weeks the treatment should be re-assessed. The CHMP emphasized that doctors and parents should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of treatment.

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