THURSDAY, Jan. 28, 2016 (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 percent confidence interval (CI), 0.40 to 4.06]; 1.21 [95 percent CI, 0.84 to 1.74]; and 2.04 [95 percent CI, 0.93 to 4.48], respectively), but there was a significant difference for aggressive behavior (OR, 1.93; 95 percent CI, 1.26 to 2.95). The odds ratios for suicidality, aggression, and akathisia were 0.81 (95 percent CI, 0.51 to 1.28), 1.09 (95 percent CI, 0.55 to 2.14), and 2.00 (95 percent CI, 0.79 to 5.04), respectively, for adults. For children and adolescents, the corresponding values were 2.39 (95 percent CI, 1.31 to 4.33), 2.79 (95 percent CI, 1.62 to 4.81), and 2.15 (95 percent 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 write. "To elucidate the harms reliably, access to anonymized individual patient data is needed."
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