The U.S. Food and Drug Administration announced that it now requires the manufacturers of "conventional" antipsychotic drugs to include a black box warning on the labeling and prescribing information of this class of drugs.
The changes are to warn about an increased risk of death associated with the off-label use of these antipsychotics to treat behavioural problems in older patients with demntia. Off-label treatments are those uses that are not FDA or manufacturer approved.
This new warning follows the updated warning, in 2005, that the FDA required on all "atypical" antipsychotic drugs. Both types of antipsychotics will now include the warning that clinical studies have found that both "conventional" and "atypical" antipsychotic drugs have been found to increase the risk of death when used on elderly patients treated for dementia related psychosis.
"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."
For a complete list of drugs that are covered by the black box warning please refer to the FDA news release on this topic:
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
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