September 17 — The antidepressant Paxil is proving to be unsafe for teens. A new analysis of the drug used to treat troubled teenagers is no longer considered safe and effective.
What researchers have found, dispite GlaxoSmithKline’s past claims, is the drug can make some teenagers suicidal and likely to harm themselves. A report published in September 17th BMJ contradicts the original study, Study 329, which stated that Paxil (paroxetine) was safe and effective for treatment of depression in adolescents. Dr. John Nardo, co-author of the new study and psychiatrist with the Emory University Psychoanalytic Institute in Atlanta stated, “Ours says paroxetine is neither safe nor effective in the treatment of adolescents, and I don’t know of any example where two studies in the literature with the same data ever reached opposite conclusions.”
An international group of researchers launched the RIAT (restoring invisible and abandoned trials) initiative that called for the release of public data behind these clinical trials for outside experts to check and assess.
GlaxoSmithKline (GSK) funded the original trial and is currently marketing the drug under the company name Apotex in the United States. One year after the drug was release in 2001, the U.S. Food and Drug Administration declared the drug to have “failed” trials, according to an editorial by BMJ Associate Editor Peter Doshi.
In 2002, more than 2 million prescriptions were written for U.S. children and teenagers due to a marketing campaign declaring that Paxil had “remarkable efficacy and safety”. By 2003 the FDA had issued a “black box” warning on the drug advising health care professionals to carefully monitor patients receiving this drug and other antidepressants due to possible worsening of depression or suicidality, especially during the first few months or upon change in dosage.
As part of the New York court settlement in 2004, GlaxoSmithKline agreed to make the date behind the study publicly available, providing electronic access to the data. Upon new analysis of the data on Paxil and Tofranil, another antidepressant used in the trial, the drugs showed the same effectiveness as the placebo. The new analysis also revealed both drugs to be significantly harmful when prescribed to adolescents.
Dr. David Henry, co-author of the second editorial in BMJ, described the original report as “misleading”. The original trial researchers ignored unfavorable data regarding potential harm by undercounting suicidal ideas or self-injurious actions of teenagers in the trial, and recategorized other behaviors that helped to alter the results.
There is no evidence yet to determine if this was a deliberate or accidental decision to skew the results, but it enabled a harmful drug to be administered to millions of children and adolescents with sometimes fatal outcomes. Dr. Henry advises people concerned about the credibility of drug studies to rely on established medical journals, peer-reviewed journals of high quality.
This recent analysis matches the longstanding view of an increased risk of suicidality in children and adolescents given antidepressants like paroxetine.
SOURCES: John Nardo, M.D., psychiatrist, Emory University Psychoanalytic Institute, Atlanta; David Henry, MRCP, FRCP, professor, University of Toronto Dalla Lana School of Public Health; Sept. 17, 2015, BMJ, U.S. National Library of Medicine, and the U.S. Food and Drug Administration.