Washington Post

FDA Issues Warning on Some Antipsychotic Drugs
By Shankar Vedantam
Tuesday, June 17, 2008

The Food and Drug Administration yesterday warned doctors that elderly
patients with dementia who are being treated with an older class of
antipsychotic drugs appear to be at increased risk of dying.

The agency ordered a "black box" warning placed on the labels of drugs
such as haldol and thorazine, which are sometimes used to pacify
demented patients who become aggressive or disturbed. A similar
warning was placed on the newer class of "atypical" antipsychotic
drugs three years ago.

Although information on the use of the older drugs in nursing homes
and elsewhere is spotty, the regulatory agency said it thinks the
older drugs were not as widely used as the newer ones, which include
Risperdal, Zyprexa and Seroquel.

Thomas Laughren, director of the FDA's Division of Psychiatry Products
in the Center for Drug Evaluation and Research, said none of the drugs
is currently approved for use among elderly patients with dementia,
meaning that doctors are using the drugs "off-label" -- which they can
legally do, based on their judgment. Laughren said it is important for
doctors to know that the drugs carry an elevated risk.

He said the agency is not saying the drugs should never be used with
elderly demented patients.

"What we want to do is make them aware of this risk," the official
said. "We would hope they would discuss -- in this case not with the
patient, because the patients have dementia -- but with caregivers and
families. These are very difficult patients to manage. They can become
very aggressive and violent and injure other patients and staff."

Link to story:
http://www.washingtonpost.com/wp-dyn/content/article/2008/06/16/AR2008061602212....

Sample black box warning

In the United States, a black box warning (also sometimes called a
black label warning or boxed warning) is a type of warning that
appears on the package insert for prescription drugs that may cause
serious adverse effects. It is so named for the black border that
usually surrounds the text of the warning. A black box warning means
that medical studies indicate that the drug carries a significant risk
of serious or even life-threatening adverse effects.