FDA Requests Boxed Warnings on Conventional Antipsychotic Drugs
- NEW YORK — June 18, 2008 — The US Food and Drug Administration (FDA) announced June 17 that manufacturers of conventional antipsychotic drugs must make safety-related changes to labelling to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioural problems in older people with dementia.
In 2005, the FDA announced similar labelling changes for atypical antipsychotic drugs. The Boxed Warning will now be added to conventional antipsychotic drugs. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.
“It is important that healthcare professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, MD, FDA Division of Psychiatry Products, 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.”
The FDA examined 2 published, observational, epidemiological studies that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs, as well as evidence from previous studies for atypical antipsychotic drugs, which suggest that both classes of antipsychotics should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.
The FDA today issued letters to the manufacturers of conventional and atypical antipsychotic drugs, notifying the manufacturers that they should make changes to drug labelling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, the Food and Drug Administration Amendments Act of 2007 (FDAAA) has provided strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.
Neither class of antipsychotics is FDA-approved for use in the treatment of dementia-related symptoms. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician.
An explanation of the data and advice for treating patients is available in an FDA notice to healthcare professionals issued June 17.
The medications involved in this action are:
Conventional Antipsychotic Drugs
Symbyax (olanzapine and fluoxetine)
For more information, see:
FDA Information for Healthcare Professionals: Antipsychotics
FDA Historical Information on Atypical Antipsychotic Drugs