SGAs®
SGAs (Second-Generation Antipsychotics)
are a class of drugs which are used to treat schizophrenia, psychosis and
bipolar mania. There are currently six SGAs on the market:
FDA Talk Paper - April 11, 2005
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 (aripiprazole),
Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone),
Clozaril (clozapine) and Geodon (ziprasidone). Symbyax, which is approved
for treatment of depressive episodes associated with bipolar 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.
Disclaimer
The antipsychotic drug litigation,
amblify, seroquel, risperdal, clozaril, geodon, symbyax, pharmaceutical
litigation or other personal injury legal information presented at this
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formation of a lawyer or attorney client relationship. Any results set
forth herein are based upon the facts of that particular case and do not
represent a promise or guarantee. Please contact a zyprexa attorney or
antipsychotic drug litigation lawyer for a consultation on your
particular personal injury matter. This web site is not intended to
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