Since Invega efficacy has not been evaluated in placebo-controlled trials for longer than six weeks, the FDA said physicians should periodically reevaluate patients who use the drug for extended periods.
The FDA cautioned that Invega belongs to the atypical antipsychotic class, and, compared with placebo, atypical antipsychotic drugs have been associated with an increased risk of death of in elderly patients with dementia-related psychosis.
The FDA added that Invega "is not approved for dementia-related psychosis."
In clinical trials. commonly reported adverse events were restlessness, extrapyramidal symptoms, rapid heartbeat and sleepiness.
