Positive opinion for Prozac in children, but with restrictions
The European Medicines Agency has recommended that the indication for Prozac (fluoxetine; Eli Lilly) be extended to include moderate to severe depression in children of eight years or older.
However, it says that Prozac should be restricted to children who have
not responded to psychological therapy alone after four to six sessions
and advises that psychological therapy should continue alongside drug
treatment. If no clinical benefit is seen within nine weeks, treatment
should be reconsidered.
The agency’s Committee for Medicinal Products for Human Use reviewed
(PDF 40K) Prozac after Eli Lilly submitted an application to extend its
licence to treat depression in children and adolescents. France requested
the
arbitration review owing to safety and efficacy concerns. The CHMP concluded
that the benefits of using Prozac for this indication outweigh the potential
risks, but that the marketing authorisation holder should carry out additional
studies to ensure that Prozac’s safety profile remains acceptable.
Eli Lilly will now request a change to the summary of product characteristics
in the UK, which it expects will happen later this year. |
The
Pharmaceutical Journal
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