Studies Lacking Antidepressant Youth Effects Data?
New analysis finds much greater risk of aggression, self-harm
By Dennis Thompson
WEDNESDAY, Jan. 27, 2016 (HealthDay News) -- Antidepressants appear to be much more dangerous for children and teens than reported in medical journals, because initial published results from clinical trials did not accurately note instances of suicide and aggression, a new study suggests.
Young people actually have a doubled risk of aggression and suicide when taking one of the five most commonly prescribed antidepressants, according to the new analysis published in the Jan. 27 issue of BMJ.
Earlier published drug trial results masked those risks by not accurately reporting suicide attempts or suicidal thoughts, and by not emphasizing instances of increased aggression, said study author Tarang Sharma, a researcher with the Nordic Cochrane Centre at the University of Copenhagen in Denmark.
The new analysis revealed these risks by skipping the published studies, and instead gathering information from detailed clinical study reports filed with government regulators as part of the drug approval process, Sharma explained.
Sharma said the differences between the published results and the data provided to regulators has shaken her faith in the summary findings of clinical trials that appear in medical journals.
"For me, the biggest lesson was never to trust a journal publication of a trial again," she said, arguing that all drug trial data should be made public. "We all need to move towards developing guidance and doing systematic reviews using the original complete data, at the individual patient level."
The Pharmaceutical Research and Manufacturers of America responded to the new analysis by pointing out a set of principles for responsible clinical drug trial data sharing that went into effect for its members in 2014.
"While we cannot comment on the specific clinical trials of various companies, our members are committed to sharing data," the industry trade group said in a statement.
Anecdotal reports have been piling up of suicidal behavior and aggression in children taking two types of antidepressants -- selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), the study authors said in background information.
The U.S. Food and Drug Administration issued a public warning in 2004 about the risk of suicide in children and teens treated with SSRIs.