Prozac Is Unsafe and Ineffective for Young People, Analysis Finds
Analysis Challenges Prozac’s Safety and Effectiveness for Young People
A comprehensive reanalysis of clinical trial data has raised serious concerns about the safety and effectiveness of Prozac (fluoxetine) for treating depression in children and adolescents. The investigation, conducted by Dr. Peter Gøtzsche and psychiatrist David Healy through the Restoring Invisible and Abandoned Trials (RIAT) initiative, reveals significant discrepancies between published studies and the original regulatory documents submitted to drug authorities.
The Original Approval and Widespread Use
Prozac received FDA approval in 2002 for treating depression in young people based on two clinical trials published in 1997 and 2002. Both studies reported modest benefits over placebo with no significant safety concerns, leading to fluoxetine becoming one of the most prescribed antidepressants for children aged 8-19 in the United States and among the top five in England.
Uncovering Hidden Data
The RIAT initiative allows researchers to examine regulatory documents that pharmaceutical companies submit to drug regulators but that often contain more complete data than what appears in published journal articles. Gøtzsche and Healy obtained these documents from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the two pivotal fluoxetine trials.
Critical Discrepancies Discovered
The comparison between regulatory documents and published papers revealed multiple serious problems:
Missing Suicide Attempts: The most alarming finding was that suicide attempts by trial participants were excluded from journal publications. In Study 1, two patients attempted suicide after 12 and 15 days of taking fluoxetine, but these critical safety events were omitted from the published article.
Compromised Blinding: Both trials had problems with “blinding,” meaning investigators likely knew which patients received the drug versus placebo, potentially introducing bias into the results.
Inadequate Washout Period: Participants already taking antidepressants were given only one week to clear the drugs from their systems before starting the trial. This caused severe withdrawal symptoms in some participants assigned to the placebo group, making it difficult to accurately assess the treatment group’s adverse effects.
No Meaningful Benefit: When the researchers reanalyzed the depression outcomes using the complete data, they found no meaningful benefit from fluoxetine compared to placebo.
Journal Response and Systemic Issues
The investigation’s author, Maryanne Demasi, contacted both journals that published the original studies requesting corrections. The Archives of General Psychiatry (now JAMA Psychiatry) rejected concerns about the omitted suicide attempts and made no corrections. The Journal of the American Academy of Child and Adolescent Psychiatry initially refused to respond until the findings were peer-reviewed, a process that took over a year.
Broader Pattern of Data Manipulation
This case mirrors the infamous Study 329 involving Paxil (paroxetine), where GlaxoSmithKline’s original publication claimed the drug was “well tolerated and effective” for adolescents. However, restoration of the complete trial data revealed the opposite: paroxetine was neither safe nor effective, with many suicidal events either omitted or disguised under vague terms like “emotional lability.”
Clinical Implications and Risks
The analysis concludes that antidepressants like fluoxetine double the risk of suicide and aggression in children and adolescents. Additional concerns include decreased quality of life, sexual dysfunction in approximately 50% of users, and persistent harmful effects that may continue after discontinuation.
Gøtzsche advocates for psychotherapy over medication, citing meta-analysis data showing that psychotherapy halved suicide attempts in patients previously hospitalized for suicide attempts. He argues that the distortion of clinical data in medical literature has reduced consideration of safer, more effective interventions.
Conclusions
The reanalysis suggests there is no rationale for using fluoxetine to treat depression in young people, concluding the drug is both unsafe and ineffective for this population. The case highlights broader concerns about the integrity of medical literature and the need for greater transparency in clinical trial reporting, particularly when it involves treatments for vulnerable populations like children and adolescents.
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