[e-drug] FDA warns against off-label use of antipsychotics in the elderly

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: FDA warns against off-label use of antipsychotics in the elderly
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[Crossposted from DRUGINFO with thanks; WB]

The FDA has acted again to address a safety issue - this time the off-label use of
atypical antipsychotics in elderly patients with behavioural disorders (dementia).
The data considered comes from a large number of trial participants - a total of
5106 patients.

~~~

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01350.html 
FDA Talk Paper
T05-13
April 11, 2005
 Media Inquiries: Susan Cruzan
                        301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory for Antipsychotic Drugs used for Treatment of
Behavioral Disorders in Elderly Patients

The Food and Drug Administration (FDA) today issued a public health advisory to
alert health care providers, patients, and patient caregivers to new safety
information concerning an unapproved (i.e., "off-label") use of certain drugs called
"atypical antipsychotic drugs." These drugs are approved for the treatment of
schizophrenia and mania, but clinical studies of these drugs to treat behavioral
disorders in elderly patients with dementia have shown a higher death rate
associated with their use compared to patients receiving a placebo (sugar pill). 

Today's advisory applies to such antipsychotic drugs as Abilify (aripiparozole),
Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril
(clozapine) and Geodon (ziprasidone). Symbyax, which is approved for treatment of
depressive episodes associated with biopolar disorder is also included in the
agency's advisory. 

FDA is requesting that the manufacturers of all of these kinds of drugs add a boxed
warning to their drug labeling describing this risk and noting that these drugs are
not approved for the treatment of behavioral symptoms in elderly patients with
dementia. Patients receiving these drugs for treatment of behavioral disorders
associated with dementia should have their treatment reviewed by their health care
providers. 
In analyses of seventeen placebo-controlled studies of four drugs in this class,
the rate of death for those elderly patients with dementia was about 1.6 to 1.7
times that of placebo. Although the causes of death were varied, most seemed to be
either heart-related (such as heart failure or sudden death) or from infections
(pneumonia). 

The atypical antipsychotics fall into three drug classes based on their chemical
structure. Because the increase in mortality was seen with atypical antipsychotic
medications in all three chemical classes, the agency has concluded that the effect
is probably related to the common pharmacologic effects of all atypical
antipsychotic medications, including those that have not been studied in the
dementia population.

The agency is considering adding a warning to the labeling of older antipsychotic
medications because limited data also suggest a similar increase in mortality for
these drugs. The review of the data on these older drugs, however, is still
on-going.

Additional information concerning today's announcement is available on FDA's
Web site at http://www.fda.gov/cder/drug/infopage/antipsychotics/default.htm and 
http://www.fda.gov/cder/drug/advisory/antipsychotics.htm.