FDA orders ‘black box’ warning for antipsychotic drugs
The agency said it would require manufacturers of the drugs to place "black box warnings" -- the FDA's most severe -- on the labels of all of the drugs.
The advisory applies to drugs including Bristol-Myers Squibb's Abilify, Eli Lilly's Symbyax and Zyprexa, AstraZeneca's Seroquel, Johnson & Johnson's Risperdal, Novartis' Clozaril and Pfizer's Geodon.
The FDA said patients receiving these drugs for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their healthcare providers.
In analyses of 17 placebo-controlled studies of four drugs in the atypical antipsychotic class, 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 or from infections like pneumonia.
Atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the agency has concluded that the effect 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 agency 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 the older drugs is still on-going, the FDA said.