The Food and Drug Administration has issued a public health advisory to highlight an increased risk of death amongst elderly patients who are prescribed atypical antipsychotic drugs in the off-label treatment of dementia.

The FDA said it was asking the drugs’ manufacturers to add a boxed warning to the products’ labels, describing the risk and noting that these drugs are not approved for the treatment of behavioural symptoms in elderly patients with dementia. The drugs in question are Bristol-Myers Squibb’s Abilify (aripiparozole), Eli Lilly’s Zyprexa (olanzapine) and Symbyax (fluoxetine plus olanzapine), AstraZeneca’s Seroquel (quetiapine), Johnson & Johnson’s Risperdal (risperidone), Novartis’ Clozaril (clozapine) and Pfizer’s Geodon (ziprasidone).

In analyses of 17 placebo-controlled studies of four drugs in this class, the FDA notes that the rate of death for elderly patients with dementia was about 1.6 to 1.7 times that of placebo. Although the causes of death were varied, most seemed to be either heart-related (such as heart failure or sudden death), or from infections (pneumonia). The FDA believes that this is a class effect, so has added the warning to all drugs in the class. In addition, the agency says it is also considering adding a warning to the labeling of older antipsychotic medications because limited data also suggest a similar increase in mortality for these drugs. The review of the data on these older drugs, however, is still ongoing.

In 2003, the FDA requested that a number of companies making atypical antipsychotics update their product labelling to include a warning about the risk of increased blood sugar levels and diabetes [[18/09/03a]].