Brittany
2008-06-19 03:33:29 UTC
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 use 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.
For more go to http://badpsych.com/2008/06/18/fda-requests-boxed-warnings-on-older-class-of-antipsychotic-drugs/
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 use 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.
For more go to http://badpsych.com/2008/06/18/fda-requests-boxed-warnings-on-older-class-of-antipsychotic-drugs/