This review included clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly’s website. Overall 70 trials (n=18 526) were examined. The researchers found that despite using clinical study reports, the true risk for serious harms is still uncertain. The low incidence of these rare events and the poor design and reporting of the trials makes it difficult to get accurate effect estimates.
An editorial notes that despite their widespread use, antidepressants are only modestly more effective than placebo in trials of depression, and measures of global clinical improvement suggest the difference is not clinically relevant or even detectable. It adds that with doubts about the efficacy and effectiveness of antidepressants and evidence that they can produce such serious adverse reactions as suicidal and aggressive tendencies, regulators and the public need access to more comprehensive and reliable data. The commentator suggests that results reported in clinical study reports, on which decisions about market authorisation are based, are likely to underestimate the extent of drug related harms. She calls for access to original data from trials and further research to describe the whole range of antidepressant induced behavioural, emotional, and physical alterations with acute treatment, long term use, and withdrawal.