European Union split on use of Prozac in kids
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A European drugs panel said on Thursday it was launching an arbitration process to resolve a dispute between EU member states over the use of Eli Lilly & Co’s Prozac to treat depression in children and adolescents.
The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) said the arbitration was initiated by France, after a number of European Union member states had raised safety and efficacy concerns about young children using Prozac.
The UK has recommended the drug can be used in children and adolescents.
The CHMP advised in April that the class of drug to which Prozac belongs, called serotonin selective re-uptake inhibitors (SSRI) medicines, should not be used in children and adolescents, except when specifically approved.
Most SSRIs are only approved for treating adults in the European Union, but doctors were sometimes prescribing them “off-label” to children.
The CHMP concluded in April that SSRIs were associated with increased suicide-related behaviour and hostility in young people.
Revision date: June 22, 2011
Last revised: by Tatiana Kuznetsova, D.M.D.
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