Black Box Warnings for Clozaril
Clozaril carries five serious warnings, called black box warnings, about possible severe side effects and drug interactions. Because of these warnings, Clozaril can only be prescribed through a special program that restricts distribution called the Clozapine Risk Evaluation and Mitigation Strategies (REMS) Program. The REMS program ensures monitoring of white blood cell (WBC) count and absolute neutrophil count (ANC) according to the schedule described below prior to delivery of the next supply of medication. Both your doctor and your pharmacist have to be registered with this program that the manufacturers created in order to prescribe and dispense your Clozaril.
Agranulocytosis
Agranulocytosis is an abnormally low WBC count. Since WBC are necessary to fight diseases, this is a potentially fatal side effect. If you are being treated with clozapine, you must have a baseline WBC count and ANC before you can start Clozaril, as well as regular WBC counts and ANCs during treatment and for at least 4 weeks after discontinuation of treatment.
Seizures
Seizures have been associated with the use of clozapine. Dose appears to be an important predictor of seizures, with a greater likelihood at higher clozapine doses. Patients should be advised not to engage in any activity where sudden loss of consciousness could cause serious risk to themselves or others.
Myocarditis and Cardiomyopathy
Myocarditis is inflammation of heart muscle and cardiomyopathy is an enlarged heart. If you have shortness of breath, fever, extreme tiredness, or chest pain while taking Clozaril, be sure to contact your doctor right away.
Orthostatic Hypotension
Orthostatic hypotension is a large, sudden decrease in blood pressure upon standing that makes you feel lightheaded or dizzy. Syncope means fainting. Rarely, this can be profound and be accompanied by respiratory and/or cardiac arrest. If you have severe diarrhea or vomiting or other signs of dehydration, be sure to tell your doctor. Also, if you accidentally skip two or more doses of Clozaril, talk to your doctor before taking your next dose as you may need to take a lower dose for a time.
Increased Mortality in Elderly Patients With Dementia
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. In one study, although the causes of death were varied, most of the deaths appeared to be either cardiovascular, meaning they were related to heart failure or sudden death, or infectious in nature. Clozaril is not approved for the treatment of patients with dementia-related psychosis.
