In 2005, the FDA issued a black box warning for antidepressants and suicidal thoughts and behavior in children and young adults.
- Many clinicians felt that this warning was inconsistent with their clinical experiences, and that it was not consistent with the data.
- In Wisconsin, the rate of prescribing these agents to children did not decrease after the black box warning was issued, and the rate of suicide did not change. In other states, where the rate of prescribing of antidepressants decreased, there was an observed increase in suicidality.
Researchers have now completed a study intended to determine the short-term safety of antidepressants by standard assessments of suicidal thoughts and behavior in youth, adult, and geriatric populations and the mediating effect of changes in depressive symptoms. They used data from intent-to-treat person-level longitudinal data of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride.
They extracted data from the suicide items of the Children’s Depression Rating Scale–Revised (CDRS-R) and the Hamilton Depression Rating Scale as well as adverse event reports of suicide attempts and suicide during active treatment. Data were analyzed from 9185 patients (fluoxetine: 2635 adults, 960 geriatric patients, 708 youths; venlafaxine: 2421 adults with immediate-release venlafaxine and 2461 adults with extended-release venlafaxine).
An analysis of the data showed that suicidal thoughts and behavior decreased over time for adult and geriatric patients randomized to fluoxetine or venlafaxine compared with placebo. No differences in suicidality were found for youths on fluoxetine or effexor compared to placebo. In adults, reduction in suicide ideation and attempts occurred through a reduction in depressive symptoms. In all age groups, severity of depression improved with medication and was significantly related to suicide ideation or behavior.
Study authors concluded that
- Fluoxetine and venlafaxine decreased suicidal thoughts and behavior for adult and geriatric patients by decreasing depressive symptoms.
- In youths, depression responded to treatment, but no significant effects of treatment on suicidal thoughts and behavior were found.
- No evidence of increased suicide risk was observed in youths receiving active medication.
See the published article:
Suicidal Thoughts and Behavior With Antidepressant Treatment
Reanalysis of the Randomized Placebo-Controlled Studies of Fluoxetine and Venlafaxine
Robert D. Gibbons, PhD; C. Hendricks Brown, PhD; Kwan Hur, PhD; John M. Davis, MD; J. John Mann, MD
Arch Gen Psychiatry. Published online February 6, 2012. doi:10.1001/archgenpsychiatry.2011.2048