Antidepressant Paxil Isn't Safe for Teens, New Analysis Says
Antidepressant Paxil Isn't Safe for Teens, New Analysis Says
Review of study data contradicts findings reported in 2001
WEDNESDAY, Sept. 16, 2015 (HealthDay News) -- A controversial clinical trial of the antidepressant Paxil came to the wrong conclusion when it declared the drug safe and effective for treating troubled teenagers, according to a reanalysis of the original data more than a decade later.
This new look finds Paxil (paroxetine) can make some teenagers suicidal and likely to harm themselves, claims a report published Sept. 17 in the BMJ.
"The original study says paroxetine is safe and effective for the treatment of depressed adolescents," said co-author Dr. John Nardo, a psychiatrist with the Emory University Psychoanalytic Institute in Atlanta.
"Ours says paroxetine is neither safe nor effective in the treatment of adolescents," Nardo added. "And I don't know of any example where two studies in the literature with the same data ever reached opposite conclusions."
This reassessment was prompted by the RIAT (restoring invisible and abandoned trials) initiative, launched by an international group of researchers, Nardo said. RIAT calls for the public release of data behind unpublished or questionable clinical trials so that outside experts can check the findings, he explained.
The original trial, known as Study 329, has been controversial ever since its 2001 publication, Nardo said.
That trial was funded by the drug's marketer, SmithKline Beecham, which is now GlaxoSmithKline (GSK). The medication is currently marketed in the United States by the drug company Apotex, GSK officials said.
A year after Study 329's release, the U.S. Food and Drug Administration declared it should be considered "a failed trial," according to an editorial by BMJ Associate Editor Peter Doshi that accompanies the new analysis.
Despite this, more than 2 million prescriptions were written for U.S. children and teenagers in 2002, spurred by a marketing campaign that said Study 329 had demonstrated Paxil's "remarkable efficacy and safety," Doshi wrote.
In 2003, the FDA mandated a "black box" warning -- the most serious type of warning in prescription drug labeling -- for Paxil and other selective serotonin reuptake inhibitor (SSRI) antidepressants. The warning signaled a possible risk of suicidal thoughts among children and teens.
Antidepressant Paxil Not Safe for Teens: Analysis
Review of study data contradicts findings reported in 2001
WEDNESDAY, Sept. 16, 2015 (HealthDay News) -- A controversial clinical trial of the antidepressant Paxil came to the wrong conclusion when it declared the drug safe and effective for treating troubled teenagers, according to a reanalysis of the original data more than a decade later.
This new look finds Paxil (paroxetine) can make some teenagers suicidal and likely to harm themselves, claims a report published Sept. 17 in the BMJ.
"The original study says paroxetine is safe and effective for the treatment of depressed adolescents," said co-author Dr. John Nardo, a psychiatrist with the Emory University Psychoanalytic Institute in Atlanta.
"Ours says paroxetine is neither safe nor effective in the treatment of adolescents," Nardo added. "And I don't know of any example where two studies in the literature with the same data ever reached opposite conclusions."
This reassessment was prompted by the RIAT (restoring invisible and abandoned trials) initiative, launched by an international group of researchers, Nardo said. RIAT calls for the public release of data behind unpublished or questionable clinical trials so that outside experts can check the findings, he explained.
The original trial, known as Study 329, has been controversial ever since its 2001 publication, Nardo said.
That trial was funded by the drug's marketer, SmithKline Beecham, which is now GlaxoSmithKline (GSK). The medication is currently marketed in the United States by the drug company Apotex, GSK officials said.
A year after Study 329's release, the U.S. Food and Drug Administration declared it should be considered "a failed trial," according to an editorial by BMJ Associate Editor Peter Doshi that accompanies the new analysis.
Despite this, more than 2 million prescriptions were written for U.S. children and teenagers in 2002, spurred by a marketing campaign that said Study 329 had demonstrated Paxil's "remarkable efficacy and safety," Doshi wrote.
In 2003, the FDA mandated a "black box" warning -- the most serious type of warning in prescription drug labeling -- for Paxil and other selective serotonin reuptake inhibitor (SSRI) antidepressants. The warning signaled a possible risk of suicidal thoughts among children and teens.
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