Pharmaceutical

Reanalysis raises efficacy, safety concerns for Paxil use in children, teens

paxil Reanalysis raises efficacy, safety concerns for Paxil use in children, teensA study published in 2001 paved the way for doctors to write millions of prescriptions of the antidepressant Paxil for children and adolescents, but a reanalysis of that study published in the British Medical Journal shows that the medication is ineffective and potentially dangerous.

The original paper, which was published by the Journal of the American Academy of Child and Adolescent Psychiatry, allegedly claimed that the drug was both safe and effective for treating depression in children and teenagers. Two years later, the Food and Drug Administration (FDA) ordered GlaxoSmithKline (GSK), the manufacturer of Paxil, to put a black box warning on the antidepressant after reports linked Paxil to suicidal thoughts. GSK was also slapped with lawsuits from parents claiming their children suffered serious reactions to the drug.

The reanalysis of the 2001 study has revealed that the paper was in large part ghostwritten by a consultant who was paid by GSK.

The researchers conducting the reanalysis pored through the raw original data and came to a very different conclusion than the first paper. Specifically, the effects of Paxil were no different than that of a placebo. There was also an increase in side effects or adverse events in study participants who took Paxil. The most concerning was an increase in suicidal thoughts and behavior.

Researchers also found in their reanalysis of the study numerous transcription errors that masked the issues and violated the company’s protocols for statistical analysis, enough so that researchers said it was as if there were “deliberate attempts to play down the adverse event profile.”

Source: Washington Post