Rosack’s FDA Watch: Atypical Antipsychotics and the Elderly
The Carlat Psychiatry Report, Volume 3, Number 8, August 2005
Jim Rosack is a widely published healthcare journalist and is the new TCR Bureau Chief for FDA Affairs.
His reports will appear periodically in the pages of The Carlat Report.
Jim Rosack has disclosed that he has no significant relationship with or financial interests in any commercial companies pertaining to this educational activity. The author has disclosed that antipsychotics have not been approved by the U.S. Food and Drug Administration for use in the treatment of agitation. Please consult product labeling for the approved usage of these drugs.
The U.S. Food and Drug Administration (FDA) has ordered manufacturers of atypical – or secondgeneration- antipsychotic medications – to add a new black-box warning to the drugs’ labels telling prescribers and patients that the drugs are associated with an increased risk of death when used to treat psychosis and behavioral problems in elderly patients with dementia.