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IMPORTANT SAFETY INFORMATION FOR PALIPERIDONE EXTENDED-RELEASE (ER) TABLETS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug- treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Neither paliperidone nor risperidone are approved for the treatment of patients with Dementia-Related Psychosis.

Commonly observed adverse events: The most commonly observed adverse events occurring at an incidence of .5% and at least 2 times placebo were akathisia and extrapyramidal disorder.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Paliperidone should be avoided in combination with other drugs that are known to prolong the QTc interval, in patients with congenital long QT syndrome or a history of cardiac arrhythmias. Certain circumstances may increase the risk of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Neuroleptic malignant syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use
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