Seniors Warned About Anti-Psychotic Drug
United Press International - April 13, 2005
U.S. health officials Monday advised physicians not to give elderly patients with dementia anti-psychotic drugs approved for other medical conditions.
The Food and Drug Administration said the drugs included in the warning were Abilify (aripiparozole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). All are approved for treatment of schizophrenia and mania but are associated with a higher death rate when given to elderly patients with dementia for behavioral problems.
Symbyax, approved for depression linked to biopolar disorder, also was included in the advisory.
Manufacturers of these drugs must add a boxed warning to their labels, FDA said, describing the risk and noting the drugs are not approved for treatment of behavioral symptoms in elderly patients with dementia.
An analysis of 17 placebo-controlled studies of four drugs in this class found the death rate for elderly patients with dementia was about 1.6 to 1.7 times that of placebo. Causes of death were varied but most seemed to be either heart-related or stem from infections.