Researchers examining the validity of the black box warning on antidepressants have concluded that the warning of the increased risk of suicidal thoughts and actions in children and young adults is clearly justified.
The best evidence available from clinical trials “demonstrated increased risk of suicidality adverse events among youth taking antidepressants,” according to researchers from universities in the United States and Australia, whose findings were published in the journal Frontiers in Psychiatry.
The researchers also examined critics’ claims that the black-box warning led to fewer prescriptions for antidepressants and, as a result, higher rates of suicide and suicide attempts.
Instead, researchers found that the rise in suicidal behavior in children and young adults occurred while prescriptions for antidepressants also increased.
“More recent data suggest that increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents,” the researchers wrote.
“The black box warning is firmly rooted in solid data, whereas attempts to claim the warning has caused harm are based on quite weak evidence,” they concluded.
A black box warning on a drug label is one of the FDA’s strongest warnings, reserved for drugs that carry significant risk of serious or fatal side effects.
The black box warning on antidepressants was first required by the FDA in 2004 to warn of the increased risk of suicidal thoughts and actions in children and adolescents. The warning was expanded in 2007 to include young adults.
“When a clear body of evidence points to increased treatment-linked risk, patients and healthcare providers should be made aware of these risks,” the researchers wrote, noting their duty to warn.
WARNING: Anyone wishing to discontinue or change the dose of a psychiatric drug is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous, even life-threatening mental and physical withdrawal symptoms.
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