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Page: << Prev | 1 | 2 However, since then, observational studies have appeared that indicate that conventional antipsychotics carry the same risk, he said. "The data we have for observational studies are not ideal, so we struggled with this decision, but in the end decided that the data were strong enough to extend the warning to all drugs in this class," he said.
When looking at the data involving atypical antipsychotics, the FDA found that over 10 weeks, roughly 4.5 percent of patients with dementia taking these drugs died, compared with 2.6 percent of patients receiving a placebo, Laughren said.
Laughren noted that all these patients were very ill in their 80s and in nursing homes. The deaths appeared to be mostly from cancer or infections such as pneumonia.
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One study by Canadian researchers, published in May in the Archives of Internal Medicine, found that elderly patients with dementia given atypical antipsychotics were 3.2 times more likely than individuals who had received no antipsychotic therapy to be hospitalized or to die during 30 days of follow-up.
Conventional antipsychotics, as well as atypical antipsychotics, are not approved for use in elderly patients with dementia, Laughren noted.
"Patients with dementia often have behavioral symptoms as well. They can have psychotic symptoms, such as delusions and hallucinations, they can be agitated, aggressive and at times violent, and antipsychotic drugs are sometimes used in treating these behavioral symptoms," Laughren said.
"We are not telling physicians that they absolutely cannot use these drugs in this setting," he added. "What we want to do is make them aware of this risk. This is something we hope they would discuss with the families and caregivers so they can understand that there are risks to using these drugs."
Both conventional and atypical antipsychotics are dopamine receptor agonists that work by blocking the action of dopamine in the brain. The primary differences between them are side effects, which are fewer among the atypical antipsychotics.
More information
For more on antipsychotic drugs, visit the U.S. Food and Drug Administration.
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