Monday, March 22, 2004
Damned if you do, damned if you don't
'FDA wants suicide warning labels on anti-depressants' - headline, FoxNews.
It isn't clear yet that the drugs actually do lead to suicide, the FDA stressed. But until that is settled, advisers to the FDA called last month for stronger warnings to doctors and parents that the antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.
Of course, unmedicated depressed people are often agitated, anxious and hostile. I suppose they also commit suicide more often than people who are not depressed. What, therefore, is the value of this warning label? Should depressed, potentially suicidal people avoid the SSRIs in light of the warning? What guidance is a doctor to give?
Disclosure is not always the perfect regulatory solution, however much I wish that it were.
It isn't clear yet that the drugs actually do lead to suicide, the FDA stressed. But until that is settled, advisers to the FDA called last month for stronger warnings to doctors and parents that the antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.
Of course, unmedicated depressed people are often agitated, anxious and hostile. I suppose they also commit suicide more often than people who are not depressed. What, therefore, is the value of this warning label? Should depressed, potentially suicidal people avoid the SSRIs in light of the warning? What guidance is a doctor to give?
Disclosure is not always the perfect regulatory solution, however much I wish that it were.
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