A new analysis finds that Prozac (generic name fluoxetine) is unsafe and ineffective for treating depression in children and adolescents.
Regulatory documents show that trial participants attempted suicide after taking fluoxetine, but these events were excluded from the final journal publication in the Archives of General Psychiatry.
I notified the journal of the new findings, but the editor refused to correct the record.
Prozac Approval
In 2002, Prozac (fluoxetine), manufactured by Eli Lilly, was FDA-approved for treating depression in children and adolescents based on data from two clinical trials.
The two trials were published in peer-reviewed journals in 1997 (Study 1) and 2002 (Study 2).
Both publications reported a small benefit of fluoxetine over placebo in young people with depression, and there appeared to be no significant safety concerns….