Paxil Leads To Self-Harm, Suicidal Behavior or Thinking: Study
Fourteen years after a study that showed Paxil was both safe and effective for treating depression in teens, a new study has unveiled that people who consumed Paxil experienced increased suicidal thoughts and behavior.
The recent re-analysis of the data was published recently in The BML. According to the Washington Post, the original paper was published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001, and it was known as Study 329.
Almost one year after the results of the Study 329 were published, the FDA reviewed the trail. According to The BMJ, the FDA officer responsible for reviewing, said, "On balance, this trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin".
Team led by Jon Jureidini in study took a new look at the original paper. They said they were shocked when they analyzed patient level data to examine the true effects of the drug.
Jureidini said it is hard to think there wasn't some mischief being done. He kept on asserting that there must have been deliberate attempts to play down the adverse event profile.
Dr. Erick Turner, an associate professor of psychiatry from the Oregon Health and Science University, expressed his initial skepticism to the New York Times saying that when he first heard about the new analysis, he thought it might be biased. But he did his own analysis and found no significant effect.
According to Dr. Healy, some teens involved in the study attempted suicide by overdose, while others suffered from severe suicidal and homicidal ideation.