I read in the May 6 issue that a review of data from placebo-controlled trials has led the FDA to require a black-box warning on atypical antipsychotic medications regarding increased risk of death related to psychosis and behavioral problems in elderly patients with dementia. However, I am not aware of the FDA's publishing any information about the increased difficulty of managing the behavior of these patients, the possible ejection of unmanageable patients from care facilities, and the impact on mortality and morbidity rates from failing to treat these patients to calm their agitated behaviors.

I agree that families need to know there are risks involved in taking antipsychotic medications, but I am concerned that the FDA is not acknowledging the increased risk from failing to treat, nor does the agency even reference the great benefits most of these patients and families derive from taking these medications.