Impact of FDA Safety Warnings Examined

A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA's system of communicating these warnings is sufficiently targeted and effective.

A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA’s system of communicating these warnings is sufficiently targeted and effective.

“Because this medication class has limited evidence of benefit among the elderly with dementia and significantly increases their risk of death, the ‘right’ magnitude of decline in usage is not clear,” said University of Rochester Medical Center neurologist Ray Dorsey, M.D., the study’s lead author. “More generally, the study raises larger issues about appropriate prescribing, particularly among the elderly, and the need to improve risk communication to patients and providers.”


Safety issues frequently emerge after a drug has been introduced to the market. These concerns arise either through ongoing clinical research or adverse events reported by post-market surveillance of the drug. The FDA can act upon this information in a number of ways. It can choose to remove the drug from the market or it can issue an advisory to physicians, the strongest of which is a “black box” warning which appears on the drug label.

The authors examined the impact of these warnings on a class of drugs called atypical antipsychotics. In April 2005, the FDA issued an advisory warning that elderly patients with dementia treated with these drugs were at increased risk of death.

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