HealthDay News — The harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors cannot be estimated accurately, according to a review published online Jan. 27 in The BMJ.
Tarang Sharma, from the Nordic Cochrane Centre in Copenhagen, Denmark, and colleagues conducted a systematic review and meta-analysis to examine serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors. Data were included from clinical study reports and summary trial reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine; 70 trials were included with 18 526 study patients.
The researchers identified limitations in the study design and discrepancies in reporting, correlating with underreporting of harms. There were no significant differences in mortality, suicidality, and akathisia (odds ratios [ORs], 1.28 [95% confidence interval (CI), 0.40 to 4.06]; 1.21 [95% CI, 0.84 to 1.74]; and 2.04 [95% CI, 0.93 to 4.48], respectively), but there was a significant difference for aggressive behavior (OR, 1.93; 95% CI, 1.26 to 2.95). The odds ratios for suicidality, aggression, and akathisia were 0.81 (95% CI, 0.51 to 1.28), 1.09 (95% CI, 0.55 to 2.14), and 2.00 (95% CI, 0.79 to 5.04), respectively, for adults. For children and adolescents, the corresponding values were 2.39 (95% CI, 1.31 to 4.33), 2.79 (95% CI, 1.62 to 4.81), and 2.15 (95% CI, 0.48 to 9.65).
“Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately,” the authors wrote. “To elucidate the harms reliably, access to anonymized individual patient data is needed.”
1. Sharma T, Cuski LS, Freund N, Gøtzsche PC. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports. BMJ. 2016; doi:10.1136/bmj.i65.
2. Moncrieff J. Misrepresenting harms in antidepressant trials. BMJ. 2016; doi:10.1136/bmj.i217.