Paxil Side Effects for Teens Actually Do Include Risk of Suicide, Self Harm: New Analysis

A recent reanalysis of a highly criticized GlaxoSmithKline study indicates that the antidepressant Paxil is neither safe nor effective for use by teenagers, potentially resulting in an increased risk of suicidal thoughts. 

The data from what is known as Study 329 was first published by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACP) in 2001, originally indicating that Paxil was safe for teens. However, the findings have recently been reanalyzed by an international team of researchers as part of an initiative known as “Restoring Invisible and Abandoned Trials” (TIAT), which resulted in very different results.

The study was a double blind randomized placebo-controlled trial involving 275 adolescents with major depression. The youths were either given Paxil (paroxetine), the antidepressant Tofranil (imipramine), or a placebo for eight weeks.

According to a reanalysis published by the medical journal The BMJ on September 16, researchers indicate that there was no statistically significant difference in treatment of depression whether the teens were given Paxil or a placebo. However, there were increases in the risk of certain Paxil side effects for teens.

“There were clinically significant increases in harms, including suicide ideation and behavior and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group,” the researchers determined. “The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.”

In an accompanying editorial, The BMJ’s associate editor Peter Doshi points out that Study 329 is one that has consistently been held up as problematic for years, however the original researchers have never issued a correction or retraction.

The study was highlighted in a government lawsuit against GlaxoSmithKline that resulted in the company paying $3 billion in criminal fines for illegally promoting Paxil and other drugs.

Investigations revealed that the 22 researchers named as authors of the study did not even write the original draft. It was instead ghost-written by Martin Keller, then Chief of Psychiatry at Brown University. Investigators found that Keller had failed to report a number of financial ties to drug companies, according to Doshi.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008. 

In 2009, GlaxoSmithKline reportedly paid about $1 billion to settle hundreds of Paxil lawsuits, including nearly $400 million to settle Paxil suicide claims.

Side effects of Paxil have been linked to an increased risk of suicidal tendencies in some users, including a risk of death or severe injuries from attempted suicides.