Is risperdal safe for elderly patients with dementia?

What risks does the FDA warn about for antipsychotics in elderly dementia patients?

The FDA requires a boxed warning on all antipsychotics, including risperidone, because clinical trials showed higher mortality rates in elderly patients with dementia-related psychosis. Studies found 1.6 to 1.7 times higher risk of death compared to placebo, most often from cardiovascular events or infections.

How does risperidone perform in clinical trials for dementia?

Clinical trials with risperidone in elderly dementia patients showed it controls agitation and aggression better than placebo. However, these trials also recorded increased rates of stroke, transient ischemic attacks, and death. The drug remains approved for schizophrenia and bipolar disorder, but not for dementia-related psychosis.

When does the risperidone patent expire?

Risperidone patents expired years ago. Generic versions are now widely available. DrugPatentWatch.com reports that the last U.S. patent protection ended in 2009.