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FDA to Require Boxed Warnings on Older Antipsychotic Drugs

Posted By Regan Zambri & Long || 25-Jun-2008

The U.S. Food and Drug Administration (FDA) utilized its new authority this month under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of older or "conventional" antipsychotic drugs to make safety-related changes to prescription information and labeling.  The required changes are to warn of an increased risk of death linked to the off-label use of these drugs to treat behavioral problems in older people suffering with dementia

This new warning comes just two years after the FDA announced similar labeling changes for newer "atypical" antipsychotic drugs in 2005.  According to the FDA’s news release the warning for both classes of drugs will say that both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis. 

The FDA news release further notes that neither class of antipsychotic is FDA -approved for use in the treatment of dementia-related symptoms, including forgetfulness, poor memory, and an inability to recognize people, sounds, and familiar objects.  The FDA does grant its approval of the use of antipsychotic drugs, but primarily for the treatment of symptoms common to schizophrenia.  However, the physician ultimately has the discretion to treat patients suffering from dementia with antipsychotics, a practice called "off-label" use.

The FDA has also issued an alert to health care professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality among elderly patients treated for dementia-related psychosis.   The FDA urges that people taking antipyschotic drugs should not abruptly stop taking them.  As always, caregivers and patients should talk to the patient’s health care professional about any concerns.

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

  • FDA Approves Antipsychotic Drug for Children Despite Disagreement from Critics
  • New Study Suggests Senior Eye Exams May Detect Early Dementia
  • Study Suggests Antipsychotics Unsafe for Elderly with Dementia

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