The Food and Drug Administration Monday issued a public health advisory telling doctors and patients to beware of potentially fatal unapproved uses of best-selling antipsychotic drugs.
The agency wants makers of all medications known as atypical antipsychotic drugs to place black box warnings -- the toughest alert from the FDA -- on labels to emphasize the risk of using these products in treating behavioral problems of elderly patients who suffer from dementia.
These drugs are not approved by the FDA for such a use. However, federal law allows doctors to prescribe a drug for any disease or condition as long as the FDA has approved a drug for a single disease.
Atypical antipsychotic drugs are approved for treating schizophrenia and mania, "but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo," the FDA says.
The public health advisory covers Abilify from
; Zyprexa from
; Seroquel from
; Risperdal from
Johnson & Johnson
; Geodon from
; and Clozaril from
Lilly's Symbyax, which is approved for treatment of depressive episodes associated with biopolar disorder, also is part of the FDA advisory.
"Patients receiving these drugs for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their health care providers," the agency said.
The FDA noted on Monday that a review of 17 placebo-controlled studies involving four of the drugs listed above showed that the death rate 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 agency says. The FDA looked at tests involving 5,106 patients in placebo-controlled trials involving Zyprexa, Abilify, Seroquel and Risperdal.
The FDA says there are three classes of atypical antipsychotic drugs, adding that the higher death rates were seen in each class. Thus, the FDA concludes that the problem "is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been studied in the dementia population."
The FDA adds that it is considering adding a stricter label to older antipsychotic drugs "because limited data also suggest a similar increase in mortality" for these products. The agency continues reviewing older products.