Tags: paxil | unsafe | teenagers | re-examination | data

Paxil Unsafe for Teenagers, Re-Examination of Data Finds

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By    |   Thursday, 17 Sep 2015 11:25 AM

The antidepressant Paxil, which has been linked to suicidal thinking or behavior, is unsafe for teenagers, according to a re-analysis of original clinical trial data that had indicated the drug was safe and effective for treating teens.

A second look at the analysis on Paxil, or paroxetine, showed the data from the first clinical trial came to the wrong conclusions, reported HealthDay.

"On the basis of access to the original data ... we report a re-analysis that concludes that paroxetine was ineffective and unsafe in this study," said a study published in the open access journal BMJ on Thursday. "Access to primary data makes clear the many ways in which data can be analyzed and represented, showing the importance of access to data and the value of re-analysis of trials."

"There are important implications for clinical practice, research, regulation of trials, licensing of drugs, and the sociology and philosophy of science. Our re-analysis required development of methods that could be adapted for future re-analyses of randomized controlled trial," said the study.

According to HealthDay, the re-examination of Paxil was sparked by a RIAT (restoring invisible and abandoned trials) initiative, started by an international group of researchers, said Dr. John Nardo, a psychiatrist with the Emory University Psychoanalytic Institute in Atlanta.

The RIAT initiative can call for the public release of data behind unpublished or questionable clinical trials to allow outside experts to review the findings, said Nardo, co-author of the new Paxil study.

"The original study says paroxetine is safe and effective for the treatment of depressed adolescents," Nardo said, according to HealthDay. "Ours says paroxetine is neither safe nor effective in the treatment of adolescents, and I don't know of any example where two studies in the literature with the same data ever reached opposite conclusions."

According to the The New York Times, questions surrounding the 2001 study led to strong warnings on the labels of Paxil and similar drugs citing the potential suicide risk for children, adolescents and young adults.

Drug giant GlaxoSmithKline, which makes Paxil, told The Times it is standing by the original study that was released 14 years ago, saying the conclusion was accurate given what was known at the time. The company said it provided "an unprecedented level of data sharing that speaks to our absolute commitment to transparency."

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The antidepressant Paxil, which has been linked to suicidal thinking or behavior, is unsafe for teenagers, according to a re-analysis of original clinical trial data that had indicated the drug was safe and effective for treating teens.
paxil, unsafe, teenagers, re-examination, data
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2015-25-17
Thursday, 17 Sep 2015 11:25 AM
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