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ROCKVILLE, Md., June 16, 2008–The U.S. Food and Drug
Administration today exercised its new authority under the Food and
Drug Administration Amendments Act of 2007 (FDAAA) to require
manufacturers of “conventional” antipsychotic drugs to make
safety-related changes to prescribing information, or labeling, to
warn about an increased risk of death associated with the off-label
nuse of these drugs to treat behavioral problems in older people
with dementia.
In 2005, the FDA announced similar labeling changes for
“atypical” antipsychotic drugs. At that time, Boxed Warnings, the
FDA’s strongest, were added. The Boxed Warning will now be added to
an older class of drugs known as “conventional” antipsychotics. 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 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.”
Antipsychotic drugs commonly are categorized into two classes,
the older “conventional” antipsychotics and the newer “atypical”
antipsychotics. Both classes of drugs are dopamine receptor
antagonists that work by blocking the action of naturally occurring
dopamine in the brain. They differ primarily in their side effects,
with the atypical drugs having a lower incidence of neurological
side effects such as involuntary movements or “tics.”
Neither class of antipsychotic is FDA-approved for use in the
treatment of dementia-related symptoms, which can include
forgetfulness, poor memory, and an inability to recognize familiar
objects, sounds, or people. The drugs are FDA-approved primarily
for the treatment of symptoms associated with schizophrenia. The
decision to use antipsychotic medications in the treatment of
patients with symptoms of dementia is left to the discretion of the
physician. Such use is often called “off-label” use and falls
within the practice of medicine.
Recently, two observational epidemiological studies were
published that examined the risk of death in elderly patients with
dementia who were treated with conventional antipsychotic drugs.
The investigators compared the risk for death with use of an
atypical antipsychotic versus either no antipsychotic or the use of
a conventional antipsychotic. These studies have limitations that
preclude reaching a definitive conclusion about comparative death
rates for atypical and conventional antipsychotic drugs.
Nevertheless, the FDA has concluded that these studies, along with
the earlier evidence for atypical antipsychotic drugs, suggest that
both classes of drugs should be considered to have an increased
risk of death when used in elderly patients treated for
dementia-related psychosis.
An explanation of the data and advice for treating patients is
available in an FDA notice to health care professionals being
issued today.
The FDA today issued letters to the manufacturers of both types
of antipsychotic drugs, under the new authority of FDAAA, notifying
the manufacturers that they should make changes to drug labeling.
Manufacturers of both classes of drugs are being asked to change
labeling 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, FDAAA provides strict timelines for resolving the
issue and allows the agency to initiate an enforcement action if
necessary.
People taking antipsychotic drugs should not abruptly stop
taking them. Caregivers and patients should talk to the patient’s
health care professionals about any concerns.
The medications involved in this action are:

Conventional Antipsychotic Drugs
Atypical Antipsychotics

Compazine (prochlorperazine)
Abilify (aripiprazole)

Haldol (haloperidol)
Clozaril (clozapine)

Loxitane (loxapine)
FazaClo (clozapine)

Mellaril (thioridazine)
Geodon (ziprasidone)

Moban (molindrone)
Invega (paliperidone)

Navane (thiothixene)
Risperdal (risperidone)

Orap (pimozide)
Seroquel (quetiapine)

Prolixin (fluphenazine)
Zyprexa (olanzapine)

Stelazine (trifluoperazine)
Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)

Trilafon (perphenazine)

For more information, see
FDA Information for Healthcare Professionals:
Antipsychotics

http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm
FDA Historical Information on Atypical Antipsychotic Drugs

http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm
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