The US Food and Drug Administration has issued a public notice regarding the fatal adverse events associated with demented patients treated with atypical antipsychotic drugs.
The notice was issued based on Seventeen controlled studies of elderly demented patients who were treated with the drugs. It was found that they were 1.6 to 1.7 times more likely to die than patients given placebo. The causes of death included congestive heart failure, sudden death, and infections, such as pneumonia.
As a result of this the FDA has asked manufacturers to place a "black box" warning on drug labels indicating an adverse reaction that may result in death or serious injury—noting the increased death rates and that the drugs were not approved for the treatment of behavioural symptoms in elderly patients with dementia.
In the recent past a number of warnings have been issued regarding atypical antipsychotic and their associated adverse events such as increased rates of stroke, obesity, and diabetes. However the world's fourth biggest selling drug of any class in 2003, making $4.3bn in global sales was the drug respiradone marketed by Johnson & Johnson's which is ranked second among the atypical antipsychotic drugs, making $2.5bn in sales in the US in 2004.
The FDA has also said that they are currently examining whether older antipsychotic agents are also associated with higher death rates and that a review of the data is still ongoing.