Is Paxil (Paroxetine) Unsafe for Teens?

New research suggests that antidepressant medications may pose a serious problem for adolescents. A study from Sweden reveals a relationship between such drugs and violent crimes. More troublesome, a new review of an old study concludes that one popular antidepressant was ineffective in treating depression but could trigger suicidal thoughts.

Study 329:

In July, 2001, a now infamous study (# 329) was published in the Journal of the American Academy of Child & Adolescent Psychiatry. The researchers enrolled roughly 180 kids starting in the late 1990s. About one third got paroxetine, one third received imipramine and one third got placebo. They were tracked for two months.

It concluded that: “Paroxetine is generally well tolerated and effective for major depression in adolescents.” 

The drug company that was marketing Paxil (paroxetine) characterized the drug as having “REMARKABLE efficacy and Safety.” Physicians responded to this campaign by writing millions of prescriptions for children and teenagers.

The Truth Comes Out…After a Long Delay:

On September 16, 2015, the BMJ published a new analysis of Study 329 under a fascinating initiative called RIAT (Restoring Invisible and Abandoned Trials). The investigators dug into the original data and concluded that paroxetine was neither safe nor effective in teenagers. The original study also included an older antidepressant called imipramine. In their own words, the researchers stated:

“Our RIAT analysis of Study 329 showed that neither paroxetine nor high dose imipramine was effective in the treatment of major depression in adolescents, and there was a clinically significant increase in harms with both drugs…

“Contrary to the original report by Keller and colleagues, our reanalysis of Study 329 showed no advantage of paroxetine or imipramine over placebo in adolescents with symptoms of depression on any of the prespecified variables. The extent of the clinically significant increases in adverse events in the paroxetine and imipramine arms, including serious, severe, and suicide related adverse events, became apparent only when the data were made available for reanalysis.”

How Could A Study Produce Such Opposite Results?

Physicians and patients have a right to be confused. One study published in a peer-reviewed journal states unequivocally that a drug is well tolerated and effective for depression. Fourteen years later, a new team of investigators analyzing the same data concludes that the drug is neither effective nor “well tolerated.”

Reviewing the Raw Data:

The new analysis involved what is referred to as “patient-level data.” The investigators writing in the BMJ scoured thousands of pages of detailed data entries for the adolescents enrolled in Study 329. It was this process that revealed “serious, severe, and suicide related adverse events” associated with paroxetine.

The authors of the new examination suggest suicidal thinking was mislabeled as “emotional lability” in the original publication. They also concluded that the benefits of paroxetine were no better than placebo.

Ethical Concerns:

A related article in the BMJ titled “No Corection, No Retraction, No Apology, No Comment…” notes some troubling aspects of the original publication of Study # 329:

“The disparity between what the manufacturer and study authors claim the trial found and what other parties say the data show was an important element in the US Department of Justice’s criminal charges against GSK. In 2012, GSK was fined a record $3bn, in part for fraudulently promoting paroxetine…

“Then there are the matters of “editorial assistance” and undisclosed financial conflicts of interests of one of the paper’s authors. The first draft of the manuscript ultimately published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) was not written by any of the 22 named authors but by an outside medical writer hired by GSK.”

The original authors challenge the review of their study and maintain that the new BMJ article does not accurately represent their work.

The Bottom Line from The People’s Pharmacy:

Prescriptions for antidepressant medications like citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft) and venlafaxine (Effexor) have skyrocketed over the last two decades. Some research has shown that one fourth of middle-aged women have received a prescription for such medications.

The CDC has noted that one out of ten Americans over 12 years of age is on an antidepressant drug. That means that tens of millions of adults and teens are regularly taking such drugs for conditions such as anxiety, ADHD, arthritis, autism, bipolar disorder, depression, fibromyalgia, hot flashes, migraines, nerve pain, OCD (obsessive compulsive disorder), panic, PMS, PTSD, premature ejaculation and goodness knows what else.

Despite the popularity of these drugs, they may not be as effective against depression as most health professionals and patients believe. In meta-analyses of the available data, many of these antidepressants are found to be just barely better than placebo, if that. This is not to say that some people do not benefit. We do hear from individuals who say that such drugs made a huge difference in their lives.

What About Suicide and Aggressive Behavior?

Self Harm:

When the suggestion was made many years ago that antidepressants might trigger suicidal thoughts, most health professionals dismissed the idea as heresy. Drug companies also resisted this suggestion. After all, these drugs were supposed to prevent suicide. How could they have the opposite effect?

We now know they actually do make some people suicidal. In fact, GSK, the maker of Paxil, responded to the kerfuffle over the new analysis of Study 329 with the following:

“…the findings from this team’s analysis appear to be in line with the longstanding view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine. This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don’t believe this reanalysis affects patient safety.”

Aggression and Violence:

Although drug companies and physicians have now accepted the possibility that antidepressants can trigger suicidal thoughts and actions, they still have a hard time imagining that these medications can also produce violence. A new study from Sweden shows that antidepressant use was associated with violent crime. They analyzed data from 856,493 individuals and discovered “an increased hazard of violent crime convictions in individuals aged 15 to 24” when people were on such drugs.

A surprising number of homicides have been noted in young people taking antidepressants. But in the U.S., the so-called “Prozac defense” doesn’t go over well with juries. People have a terrible time wrapping their heads around the notion that a medication might cause someone to do something violent. Perhaps the Swedish data will change that perspective.

What Do You Think?

Share your thoughts about antidepressant medications below. Do you think such drugs could trigger suicide or violence? What has been your own experience with such medicines? Please vote on this article at the top of the page.