September 17, 2015 — A re-evaluation of a controversial clinical trial has concluded that Paxil is not safe for children and teenagers.
After obtaining raw data from Study 329, investigators found that teenagers on Paxil did no better than a placebo. The re-analysis also found concerning evidence that adverse events were downplayed.
Eleven patients on Paxil engaged in suicidal or self-harming behaviors, compared to just one on a placebo. Five out of six adverse events labeled “emotional lability” in the original study actually involved suicidal thinking or behavior — including one patient who was hospitalized with severe suicidal and homicidal ideation toward his parents.
The re-analysis of Study 329 was published in the British Medical Journal by Jon Jureidini, a researcher at the University of Adelaide. He said:
“This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them.”
Study 329 was originally published in 2001 by Dr. Martin Keller of Brown University. Researchers split teens into groups of 90 and gave them Paxil, a placebo, or an older antidepressant called imipamine.
The conclusion of the study was that Paxil was “generally well tolerated and effective,” which led to a marketing campaign that promoted Paxil’s “remarkable efficacy and safety.” The results were immediate — antidepressant prescriptions in teens surged 36% from 2002-2003, only slowing after the FDA added a “Black Box” warning about suicide among teenage patients in October 2004.
However, the study was not actually written by any of the 22 named authors, but by an outside medical writer hired by GlaxoSmithKline (GSK). Dr. Keller was also investigated for under-reporting financial conflicts of interest with drug-makers.
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