I read with interest the article in the March 17 issue reporting that physicians are not attending to the black-box warnings in the way in which they were intended. I have noted that in the past two years antidepressants (concerning suicide risk in children and adolescents as well as adults) and second-generation antipsychotics (concerning cerebrovascular events in dementia patients) now have black-box warnings. Moreover, stimulants are also under consideration for a black-box warning for cerebrovascular events.

One would expect that a black-box warning would be used only for severe and well-proven risks. After reviewing the data on these warnings, I cannot say this appears obvious. In the September 2005 Journal of Clinical Psychiatry, Rosa Liperoti and colleagues reported that there is no apparent link between second-generation antipsychotics (SGAs) and cerebrovascular events in individuals with dementia. The study was sponsored by NIH. This would appear to be the most definitive research on the issue, yet I hear no discussion about withdrawing the black box from the labeling of SGAs.

It appears to me that the FDA has lowered the threshold for adding black-box warnings and is reluctant to withdraw them even in the face of contradictory data. It is therefore difficult to attend the warnings with the same vigor as I have in the past. One hears echoes of the little boy who cried wolf.