Reanalysis Confirms Long Held Suspicions — Paxil Is Unsafe and Ineffective for Teens (Part One)


Reanalysis Confirms Long Held Suspicions — Paxil Is Unsafe and Ineffective for Teens


October 08, 2015


Watch the video about ‘Study 329’:


By Dr. Mercola


Antidepressants are among the most prescribed types of drugs in the US, (1) despite the fact that many of them have also been linked to violence against self and others.


In 2004, the US Food and Drug Administration (FDA) revised (2) the labeling requirements for antidepressant medications (SSRIs and others), warning that:


“Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.


Anyone considering the use of [Insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.”


These labeling revisions were in large part driven by lawsuits in which pharmaceutical companies were forced to reveal previously undisclosed drug data.


The following year, the FDA issued yet another advisory; this time warning women that taking Paxil during pregnancy could result in a number of debilitating birth defects, (3) including congenital heart defects.


GlaxoSmithKline Has Paid $4 Billion in Settlements Related to Paxil


A civil lawsuit filed in 2004 (4) charged GlaxoSmithKline (GSK) with fraud, claiming the drug maker hid results from studies on Paxil showing the drug did not work in adolescents and in some cases led to suicidal ideation.


Rather than warning doctors of such potential side effects, GSK encouraged them to prescribe the drug to teens and children, which led to a significant increase in prescriptions — and violence, including suicides and homicides.


A study (5) by the Institute of Safe Medication Practices published in 2010 identified 31 commonly-prescribed drugs disproportionately associated with violent acts. Paxil ranks third on this list.


A study by the Drug Safety Research Unit in Southampton [United Kingdom] showed that one in every 250 subjects taking Paxil or Prozac were involved in a violent episode.


In 2011, a whopping 14 million prescriptions for Paxil were written in the US, (6) potentially equating to some 56,000 drug-induced incidents of violence annually from this drug alone.


GSK has paid out more than $1 billion to settle more than 800 different lawsuits related to Paxil, (7) in addition to a $3 billion settlement with the US Department of Justice for the illegal marketing of Paxil and other drugs [http://articles.



Yet Paxil has remained a “staple” in the psychiatrist’s arsenal. Perhaps this will finally change once the most recent research into Paxil becomes more widely known...


GlaxoSmithKline’s Paxil Research Refuted by New Study


In 2001, GSK published a study (8, 9) known as “Study 329,” showing Paxil was both safe and effective for teenagers but now, a reanalysis (10,11,12) of the original data has concluded neither is true.


As reported by The New York Times: (13)


“Antidepressant trials are an extremely tricky enterprise, in part because anywhere from a third to more than half of subjects typically improve on placebo.


Choices about how to measure improvement — and how to label side effects — can make all the difference in how good a drug looks. And so it was in the Paxil study.


The original research... tracked depression scores over eight weeks in three groups of about 90 adolescents each, one taking Paxil, one on placebo pills, and one taking imipramine, an older generic drug for depression.


The Paxil group did no better than the other two groups on the study’s main measure — a standard depression questionnaire — but did rate higher on other, ‘secondary’ measures, like another scale of mood problems, the authors reported.


Researchers consider secondary measures like these as akin to circumstantial evidence, potentially meaningful but not as strong as the primary ones...”


To be continued…


Sources and References


(1), Therapeutic Drug Use

(2), Revisions to Product Labeling (PDF)

(3, 7) Paxil Lawsuits

(4) New York Times June 3, 2004

(5) PLoS ONE 5(12): e15337

(6), Prescriptions for 2011

(8) Child and Adolescent Psychiatry July 2001: 40(7); 762-772

(9, 16) Retraction Watch September 16, 2015

(10) BMJ 2015;351:h4320

(11) September 17, 2015

(12) Reuters September 16, 2015

(13) New York Times September 16, 2015


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Further References:


Article Credit: Mercola, J. “Reanalysis Confirms Long Held Suspicions — Paxil Is Unsafe and Ineffective for Teens.” Dr. Joseph Mercola, published 8 October 2015. Accessed 18 October 2015. <




Image Credit: U.S. National Library of Medicine, MedlinePlus. <>. Published 30 October 2013. Accessed 18 October 2015.


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