Eli Lilly’s Prozac should be approved for the treatment of children and adolescents with depression, according to the European Commission’s Committee for Medicinal Products for Human Use.
The CHMP issued a positive opinion on Lilly’s application to extend approval of Prozac (fluoxetine) to include children aged eight or over, although it said Lilly should carry out additional studies to keep an eye on the safety profile of the drug in these patients.
Lilly filed for approval to extend Prozac’s indications to include children at the request of the UK as part of a move to identify drugs which may be safe for use in the paediatric medicine setting.
The CHMP was requested to begin an arbitration review by France on the basis of unresolved safety and efficacy concerns.
Specifically, the selective serotonin reuptake inhibitor (SSRI) class of antidepressants to which Prozac belongs has been linked with an increase in suicidal behaviour in children and adolescents, and regulators on both sides of the Atlantic have heightened their warnings on the use of these drugs in the under-18s.
In 2004, the FDA ordered that all antidepressants – including the SSRIs – carry a black box warning to warn of the risk, although this decision has been challenged by the American Medical Association which says the data to establish a causal link simply doesn’t exist.
Last year, the AMA said that trials have shown that Prozac is effective in treating children and adolescents with major depressive disorder, while noting that "longer and better-designed paediatric studies are needed to address safety and efficacy concerns."
The CHMP has concurred with this view, saying that Prozac should be used in children who have not responded to psychological therapy after four to six sessions, up to maximum daily dose of 20mg. It also recommends that doctors and parents should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of treatment.