Physicians are apparently getting the message: Using atypical antipsychotic medications to treat dementia, against U.S. Food and Drug Administration (FDA) recommendations, can be a really bad idea.
According to a report in the February issue of Archives of General Psychiatry, prescriptions for these drugs (which include Seroquel, Abilify, Risperdal and others) significantly declined after the FDA warned that their off-label use in the treatment of dementia in older adults was linked to more deaths.
The report states, “In 2001, more than 70 percent of U.S. atypical antipsychotic prescriptions were written for off-label indications such as dementia. Atypical antipsychotics accounted for 82 percent of antipsychotic prescriptions written for older patients in Canada in 2002.”
An “off-label” indication is one that has not been specifically tested or approved by the FDA for a given medication. Any doctor is free to prescribe any medication they deem appropriate for any indication, once a medication has been approved for any use by the FDA.
Atypical antipsychotics were first approved for use in the U.S. for the treatment of schizophrenia. They have never been approved for use in the treatment of dementia.
“In 2005, the Food and Drug Administration (FDA) issued a black box warning [the strongest warning possible] that stated, ‘Treatment of behavioral disorders in elderly patients with dementia with atypical antipsychotic medications is associated with increased mortality,” the report stated.
To examine changes in the use of atypical and conventional antipsychotic medications for treatment in patients with dementia, Helen C. Kales, M.D., of the University of Michigan, Ann Arbor, and colleagues reviewed data from more than 250,000 patients with dementia.
Atypical antipsychotic medications are second generation medications, while conventional antipsychotics are considered first generation. Both kinds of medications have significant side effects for many people who take them.
Data were collected from the national Veterans Affairs (VA) registries maintained by the Serious Mental Illness Treatment, Research and Evaluation Center in Ann Arbor, Mich., for veterans age 65 or older who received a dementia diagnosis between April 1999 and September 2007.
The overall study period was divided into three sections: no warning (1999-2003), early warning (2003-2005) and black box warning (2005-2007).
At the beginning of the study, 17.7 percent of patients with dementia were using atypical or conventional antipsychotics. Overall antipsychotic use began to decline during the no warning period.
However, use of atypical antipsychotics increased during the no-warning period, began to decline during the early-warning stage and more sharply declined during the black box warning period.
By 2007, overall use of antipsychotics for treatment leveled off at 12 percent of all patients with dementia.
The percentage of VA patients with dementia using psychotropics (antipsychotics plus antidepressants, anxiolytics and anticonvulsants) remained consistent at 40 percent during the study and the number of patients not receiving these medications also remained constant around 60 percent.
The authors concluded that VA patients with dementia continued receiving medication after the black box warning and were not taken off medication completely.
“In this national VA sample, we found that use of both conventional and atypical antipsychotics for patients with dementia began to decline significantly well before implementation of the black box warning,” the authors wrote.
“In conclusion, use of atypical antipsychotics for patients with dementia began to decline significantly in 2003, and the FDA advisory was temporally associated with a significant acceleration in the decline.”
The study appears in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.