United States – New evidence suggests that ‘Black Box’ warnings of potential dangers added to antidepressants might have actually helped to cause more suicides and deaths among youngsters.
The alerts state that antidepressants could increase the risk of suicidal thinking and behavior in children and adolescents, the purpose of which was to make doctors pay more attention to the young patients taking the medications, experts explained, as reported by HealthDay.
Instead, it has made doctors reconsider their options for prescribing antidepressants to youth and probably has led to a decrease in mental health among kids and teens, findings depict.
Antidepressant Prescriptions Drop, Suicide Rates Rise
“These consequences of the warnings are, however, sudden, simultaneous, and universal and it is these drastic changes – the cut in the use of anti-depressants and a rise in mortality from suicide – that this study establishes over 14 years of robust research” the lead researcher in the study, Prof Stephen Soumerai from the Pilgrim Health Care Institute Harvard Medical School, said.
Since 2003, the US FDA has stated that antidepressants might lead to the risk of suicidal thoughts and actions in children.
A Black Box was inserted, and the FDA ordered it. Labeling of antidepressants should contain a Black Box warning notifying the doctors of this possible effect in kids below eighteen years. In 2007, the FDA expanded the warning to young adults up to 24 years of age.
FDA Expanded the Warnings but Screenings Remained Low
The potential impact of the warning regarding the risk of suicide on the treatment of depression was explored by the meta-analysis of the study data pooled from 11 trials conducted between 2003 and 2022.
The data reveal that less than 5% of young patients were screened for suicidal ideation and behavior as was advised by the warning. Ultimately, this rate did not change” before and “after the FDA mandated the warning.
However, seven of them established that antidepressant treatment, as well as its usage, reduced between 20-50% during that period.
Study Calls for Re-Evaluation of Black Box Warnings
Similar trends indicated that there was a progressive rise in antidepressant prescriptions in the years prior to the first FDA cautionary notice and a sharp, persisting decline in the subsequent years after the issuance of the warnings, as reported by HealthDay.
“The consistency in observed harms and absence of observed benefits after the Black Box warnings indicate this is not a coincidence,” Soumerai said in a Harvard news release. “We recommend that the FDA consider incorporating the Black Box warnings into the list of routine warnings that pose fewer health risks or potentially removing the warnings altogether.”