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FDA Black Box Warning For Atypical Antipsychotic Drugs Increased Mortality in Elderly Patients With Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated... |
FDA Black Box Warning For Atypical Antipsychotic Drugs Increased Mortality in Elderly Patients With Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. [Name of Atypical Antipsychotic] is not approved for the treatment of patients with dementia-related psychosis. |
Research posted on the British Medical Journal’s Web site on March 23 suggests that a nursing home staff training program involving person-centered care and good practice in the management of patients with behavioral problems related to dementia provides an effective alternative to antipsychotic drugs.
The research was conducted in 12 nursing homes in the United Kingdom and included a total of 349 patients. The full text of this study can be found on the journal’s Web site at: http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38782.575868.7Cv2.
The 12 nursing homes were randomly assigned to one of two groups. In one group, the staffs of six nursing homes received 10 months of training and support focusing on alternatives to drugs for the management of agitated behavior in dementia. A psychiatrist worked with the staffs two days a week to reduce the prescribing of antipsychotic drugs. In another group, the residents of six nursing homes continued to receive their usual care.
The researchers measured the percentage of patients who were prescribed antipsychotic drugs in the two groups of nursing homes. Patients’ levels of agitated and disruptive behavior were measured using a standardized survey.
After one year, the percentage of patients using antipsychotic drugs in the six nursing homes receiving training and support was significantly lower (23 percent) than that in the nursing homes whose patients received usual care (42.1 percent). This is an average reduction in antipsychotic drug use of 19.1 percent.
No significant differences were found in the levels of agitated or disruptive behavior between the two groups of nursing homes.
The researchers concluded:
“Promotion of person-centred care and good practice in the management of patients with dementia with behavioral symptoms provides an effective alternative to neuroleptics [antipsychotic drugs].”
The use of antipsychotic drugs in elderly patients who are not psychotic presents significant safety problems. In April 2005, the Food and Drug Administration (FDA) issued a public health advisory to warn that the drugs known as the “atypical antipsychotics” are associated with an increased risk of death when used to treat dementia in elderly patients (see Worst Pills, Best Pills News, July 2005 ).
The drugs affected by this FDA advisory are aripiprazole (ABILIFY), olanzapine (ZYPREXA), quetiapine (SEROQUEL), risperidone (RISPERDAL), clozapine (CLOZARIL) and ziprasidone (GEODON) and olanzapine with fluoxetine (SYMBYAX). These drugs are approved by the FDA to treat schizophrenia except for SYMBYAX, which is approved to treat depressive episodes associated with bipolar disorder.
None of these drugs, however, are approved for the treatment of behavioral disorders in patients with dementia.
Since September 2005, all the atypical antipsychotics now carry a black-box warning in their professional product labels. A black-box warning is the strongest type of alert that the FDA can request of a drug manufacturer.
What You Can Do
If you are a family member of an elderly person residing in a nursing home who has not been diagnosed as psychotic but is nonetheless receiving an antipsychotic drug, talk to the prescribing physician about other options, such as an increase in skilled nursing care.
