Recently the FDA exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of “ conventional” antipsychotic drugs to make safety-related changes to prescribing information on labeling, to add black box warnings 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 required black box warnings, the strongest warnings possible, for “atypical” antipsychotic drugs. 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.
SOURCE: FDA News Release
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