Clozapine (the generic medication for Clozaril) is an anti-psychotic medication approved for use in schizophrenia patients and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder.
Clozaril carries five black box warnings–the FDA’s strongest warning. Consequently, Clozaril is only approved for use in limited circumstances and the FDA requires ongoing monitoring of the patients to minimize the risk of complications.
Clozapine’s Black Box Warnings
- Arganulocytosis – An abnormally low white blood cell count. Since white blood cells are necessary to fight diseases, this is a potentially fatal side effect. Patients being treated with Clozapine must have a baseline whie blood cell (WBC) count and absolute neutrophil count (ANC) before initiation of treatment as well as regular WBC counts and ANCs during treatment.
- Seizures – Seizures have been associated with the use of Clozapine. Studies have conclusively demonstrated that the incidence of seizures increases as the dosage increases. Additionally, patients taking Clozapine, should be advised not to engage in any activity where sudden loss of consciousness could cause serious risk to themselves or others.
- Myocarditis – Inflamation of the heart muscle. The incidence of myocarditis has been demonstrated to substantially increase in the first month of use.
- Orthostatic Hypotension – A large, sudden decrease in blood pressure upon standing that can result in falls.
- Increased Mortality in Elderly Patients with Dementia – Elderly patients with dementia-related psychosis treated with atypical anti-psychotic drugs, such a Clozapine, are at an increased risk of death compared to placebo.
Berman & Riedel, LLP represents many California nursing home residents who were victims of wrongful overmedication by nursing homes. If you believe you or a loved one was the victim of an overmedication incident by a nursing home or other type of elder care facility, call Berman & Riedel, LLP today at (858) 350-8855. Our staff will happily provide you and your family with an initial free consultation to discuss with you questions or concerns you may have and can explain to you the rights you and your family may have under California and federal law. To learn more about elder abuse and neglect related issues, visit the firm’s main website at www.preventelderabuse.com.
