We believe our study shows 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.
The FDA has advised that antidepressants may also cause suicide in young adults (18 to 24 years) and recommends that “patients of all ages” treated with antidepressants should be monitored for “clinical worsening, suicidality, and unusual changes in behaviour.”
42 GlaxoSmithKline also issued letters to doctors, informing them about the increased harm in young adults
6 and admitted that for adults with depression “(all ages), the frequency of suicidal behaviour was higher in patients treated with paroxetine compared with placebo: 11/3455 (0.32%) versus 1/1978 (0.05%).”
43 A cohort study from Sweden recently showed an increase in violent crime in young adults taking antidepressants (hazard ratio 1.43, 95% confidence interval 1.19 to 1.73).
44
Therefore we suggest minimal use of antidepressants in children, adolescents, and young adults, as the serious harms seem to be greater, and as their effect seems to be below what is clinically relevant.
4 45 46 47Alternative treatments such as exercise
48 49 or psychotherapy
4 50 may have some benefit and could be considered, although psychotherapy trials also suffer from publication bias.
51
The need for identifying hidden information in clinical study reports to form a more accurate view of the benefits and harms of drugs has been highlighted by the Restoring Invisible and Abandoned Trials (RIAT) initiative,
52 and the recent revised version of trial 329.
36 More data from clinical study reports are expected to become available in the coming years, with the EMA’s new policy to make all newly submitted reports publicly available.
53 As it can be quite labour intensive to perform systematic reviews using clinical study reports, more reliable automated methods for text mining are needed, such that all data, including that from individual patient listings and case report forms, can be routinely considered.
36 54