The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia.
Doctors sometimes use antipsychotics to help treat behavioral problems in demented patients.
But from now on these older, so-called "conventional" antipsychotics -- which include drugs such as thorazine and prolixin -- will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.
"We issued letters to all the manufacturers of antipsychotic drugs, both conventional and atypical, requiring them to update their labeling with new language for a box warning about an increased risk of death in elderly patients with dementia," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference.
This is a new warning for conventional antipsychotics, but it is not new for another class of the medications, called atypical antipsychotics. Back in 2005, the FDA ordered warning labeling for those medications, which include newer drugs such as Zyprexa and Risperdal. That labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.
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