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Off-Label Prescription Cautions For Seniors With Dementia May Not Be Heeded Enough

January 13, 2010
A study just published in the Archives of Internal Medicine examines the impact of a safety warning issued over 4 years ago by the Food and Drug Administration about a class of drugs called atypical antipsychotics. While atypical antipsychotic drugs have only been approved by the FDA to treat conditions such as schizophrenia and bipolar affective disorder, these drugs are often used to treat conditions for which they have not been licensed, a practice referred to as "off-label." In this case, the FDA warning applied to the off-label use of these drugs to treat behavioral disorders in elderly patients with dementia. The FDA issued the advisory after data from clinical studies of these drugs in this population showed a 60-70% higher death rate than those receiving a placebo. Before the issuance of the FDA warning, use of these drugs among patients with dementia was growing at an average annual rate of 16%. In the year following the advisory, their use among this population fell by 19%. Use of antipsychotics continued to decline in subsequent years, and by 2008 their use among the elderly with dementia was about 50% less than before the warning. Said University of Chicago Medical Center internist Caleb Alexander, MD, co-author of the study, "All too often, these drugs have been used in settings with unclear benefits and unacceptable risks, and despite the decreases we document many elderly with dementia continue to receive these therapies." Warnings that involve off-label use of medications create a complex set of problems for regulators and physicians. The elderly are historically under-represented in clinical trials, which forces physicians to apply evidence obtained from one population to another population where the risk to benefit trade-off may be different. When the risks are significant, the FDA must develop the right message and ensure that it reaches the target audience, which in this instance was for a usage that had not been approved by the agency. The authors of the study contend that the approach currently employed by the FDA needs to be supplemented with efforts that target the most frequent prescribers of the medication, as opposed to a blanket communication to all physicians, and a coordinated effort between the FDA and the drug's manufacturers to inform patients and their families of safety risks. Additionally, suggest the authors, advisories may need to contain more specific information for providers, such as potential alternative treatments. Without such direction, physicians could potentially end up choosing a drug that is worse. A potential alternative to antipsychotic medication is conventional antipsychotic therapy, a treatment option that could expose patients to even greater safety risks. "This study points to the clear need to improve the manner by which we communicate drug advisories to the public," said University of Rochester Medical Center neurologist Ray Dorsey, MD, the study's lead author.