Warning on Drugs for Elderly Behavioral Issues
FDA Orders Warning Labels After More Deaths Seen in Elderly Patients With Dementia
April 11, 2005 -- The FDA has issued a public health advisory about certain drugs used to treat behavioral problems in elderly patients with dementia.
That's an unapproved use of the drugs, called antipsychotic drugs, which include:
- Symbyax, which is approved for treating depressive episodes associated with bipolar disorder.
The FDA's warning does not extend to people who are taking the drugs for the approved uses - treating schizophrenia and mania.
These drugs are sometimes used to treat agitation and other behavior disturbances in elderly patients with dementia, such as Alzheimer's disease. Doctors should review treatment for elderly patients with dementia who are taking the drugs for behavioral problems, says the FDA's advisory.
The FDA's decision was based on 17 studies of four of the drugs (Zyprexa, Abilify, Risperdal, and Seroquel) in elderly patients with dementia and behavioral disorders.
In those studies, the death rate was about 1.6 to 1.7 times higher for elderly patients with dementia than for those taking a placebo.
The causes of death varied. Most seemed to be either heart-related (such as heart failure or sudden death) or from infections (mostly pneumonia), says the FDA.
Atypical antipsychotic drugs fall into three categories based on their chemical structure. Because the increased death rate was seen with drugs from all three classes, the FDA concluded that the effect is probably related to common effects of all such drugs, including those drugs that haven't been studied in people with dementia.
New Warning Labels
The FDA has asked the drugs' makers to add a boxed warning to the drugs' labels describing the risk. The label will also note that the drugs are not approved for the treatment of behavioral symptoms in elderly patients with dementia.
The FDA says it's considering adding a similar warning to the labeling of older antipsychotic medications, such as Haldol, because limited data also suggest a similar increase in deaths for these drugs. However, the FDA's review of data on those older drugs isn't done yet, says an FDA news release.