Children as young as 8 may soon be able to use the antidepressant drug Prozac, following a recommendation by the European Medicines Agency (EMEA). Prozac (fluoxetine), manufactured by Eli Lilly, is a SSRI (selective serotonin reuptake inhibitor) -- the most commonly prescribed class of antidepressant.
The drug is authorized for the treatment of major depressive episodes, obsessive compulsive disorder and bulimia nervosa.
Although the drug is not currently recommended in Europe for people under age 18, the EMEA stated that Prozac should be considered in the treatment of children aged 8 or older who suffer from moderate-to-severe depression and who do not respond to psychological therapy.
"The agency concluded that the benefits of using Prozac in this indication outweigh its potential risks, but that the marketing authorisation holder, Eli Lilly, should carry out additional studies to ensure that the safety profile of Prozac remains acceptable", the agency said in a statement.