Serivan

Warnings & Precautions

Increased mortality in elderly patients with dementia-related psychosis Antipsychotic drugs raise the risk of death from all causes in elderly patients with dementia-related psychosis. Analyses of 17 placebo-controlled trials in dementia-related psychosis (the usual length was 10 weeks, and most patients were taking atypical antipsychotic drugs) found that patients on the drug were 1.6 to 1.7 times as likely to die as those on placebo. In a typical 10-week controlled trial, about 4.5% of drug-treated patients died, compared with about 2.6% of placebo-treated patients. The causes of death varied, but most seemed to be either cardiovascular (for example, heart failure or sudden death) or infectious (for example, pneumonia). Pimavanserin is not approved for dementia-related psychosis that is unrelated to the hallucinations and delusions of Parkinson's disease psychosis. QT interval prolongation Pimavanserin prolongs the QT interval. Avoid it in patients with known QT prolongation, and avoid using it with other drugs known to prolong the QT interval. These include Class 1A antiarrhythmics (e.g., quinidine, procainamide), Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medicines (e.g., ziprasidone, chlorpromazine, thioridazine) and certain antibiotics (e.g., gatifloxacin, moxifloxacin). Pimavanserin should also be avoided in patients with a history of cardiac arrhythmias. The same applies to other circumstances that may raise the risk of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and congenital prolongation of the QT interval.