MONDAY, June 16 (HealthDay News) -- 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.
This new black box warning for older, conventional
antipsychotics is one of the first uses by the agency of the Food
and Drug Administration Amendments Act of 2007, which gives the FDA
authority to mandate drug warnings, something they could only
request before.
According to Laughren, the FDA based its 2005 decision on a
review of studies comparing their use to a placebo. At the time, a
lack of evidence prevented the agency from extending the warning to
conventional antipsychotics, Laughren said.
However, since then, observational studies have appeared that
indicate that conventional antipsychotics carry the same risk, he
said. "The data we have for observational studies are not ideal, so
we struggled with this decision, but in the end decided that the
data were strong enough to extend the warning to all drugs in this
class," he said.
When looking at the data involving atypical antipsychotics, the
FDA found that over 10 weeks, roughly 4.5 percent of patients with
dementia taking these drugs died, compared with 2.6 percent of
patients receiving a placebo, Laughren said.
Laughren noted that all these patients were very ill in their
80s and in nursing homes. The deaths appeared to be mostly from
cancer or infections such as pneumonia.
One study by Canadian researchers, published in May in the
Archives of Internal Medicine, found that elderly patients
with dementia given atypical antipsychotics were 3.2 times more
likely than individuals who had received no antipsychotic therapy
to be hospitalized or to die during 30 days of follow-up.
Conventional antipsychotics, as well as atypical antipsychotics,
are not approved for use in elderly patients with dementia,
Laughren noted.
"Patients with dementia often have behavioral symptoms as well.
They can have psychotic symptoms, such as delusions and
hallucinations, they can be agitated, aggressive and at times
violent, and antipsychotic drugs are sometimes used in treating
these behavioral symptoms," Laughren said.
"We are not telling physicians that they absolutely cannot use
these drugs in this setting," he added. "What we want to do is make
them aware of this risk. This is something we hope they would
discuss with the families and caregivers so they can understand
that there are risks to using these drugs."
Both conventional and atypical antipsychotics are dopamine
receptor agonists that work by blocking the action of dopamine in
the brain. The primary differences between them are side effects,
which are fewer among the atypical antipsychotics.
More information
For more on antipsychotic drugs, visit the
U.S. Food and Drug Administration.
