Reanalysis Confirms Long Held Suspicions — Paxil Is Unsafe and Ineffective for Teens
Antidepressants are among the most prescribed types of drugs in the US, 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 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.
October 8, 2015 | Source: Mercola | 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) revised2 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 20044 charged GlaxoSmithKline (GSK) with fraud, claiming the drugmaker 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 study5 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 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.
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…