THE CHALLENGE TO PAXIL

THE CHALLENGE TO PAXIL: 

SAFE AND EFFECTIVE FOR ADOLESCENTS?

NOT SO MUCH…

In 2001, a major study reported in the Journal of the American Academy of Child and Adolescent Psychiatry indicated that Paroxetine (most commonly known in the US  by the trade name Paxil as well as other names) and Imipramine (US trade name Tofranil) was safe and effective for treating depression in adolescents. It has taken almost 15 years and the RIAT Act (see below) for a new study to re-evaluate those findings.

In a reanalysis of the original study, called Study 329, results indicated that not only was there no clinically or significantly statistical advantage for these medications over placebo, but there was significant increase in harm to adolescents in using these drugs. The harms range from increased suicidal ideation and behavior to  cardiovascular problems with Imipramine.

In 2004, the US Food and Drug Administration added the black box warning that advised against the use of paroxetine in adolescents. In 2012, Glaxo-Smith-Kline (GSK), the manufacturer  of Paroxetine, was fined $3 Billion for their participaton in the fraudulent promotion of paroxetine.

And yet, here we are at the end of 2015 still talking about this… and it looks like we’ll need to continue to do so until people stop thinking of Paxil and the other antidepressants as the best treatment for depression when the evidence says otherwise.