A 2001 study of antidepressant Paxil, or paroxetine, found it to be a safe and effective treatment for depression in adolescents. Fourteen years later, a second study based on identical data has found the opposite: Paxil can make young people suicidal and likely to hurt themselves, researchers say, per HealthDay. As part of an initiative to revisit controversial trials, scientists reviewed the original study of 275 kids diagnosed with major depression, aged 12 to 18, who were given either Paxil, antidepressant Tofranil, or a placebo. Contrary to the original trial, known as Study 329 and funded by Paxil's marketer, they found Paxil and Tofranil were no more effective in treating depression than a placebo, yet boosted a patient's risk of self-harm. Why the turnaround? Researchers say some suicidal ideas or actions were wrongfully placed in the "emotional lability" category in 2001, including the case of a teen hospitalized after taking 80 Tylenol tablets, reports the New York Times.
"I don't know of any example where two studies ... with the same data ever reached opposite conclusions," an author of the new study says. The original was clearly "misleading," adds a researcher, but "it's not clear whether it was deliberate or accidental." An accompanying editorial notes the FDA declared Study 329 should be considered "a failed trial" in 2002, a year after its release, yet more than 2 million prescriptions were written for US kids and teens that year. In 2003, the FDA began requiring a "black box" warning label describing a risk of suicidal thoughts for Paxil and other selective serotonin reuptake inhibitor antidepressants. Though drug marketer GlaxoSmithKline acknowledges the increased risk of self-harm, it adds, "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."