The Food and Drug Administration (FDA) announced that there have been technical difficulties with the new clozapine risk evaluation and mitigation strategy (REMS) website that may have prevented some pharmacies and prescribers from completing their required certification, resulting in problems with patient access.
Clozapine manufacturers, the REMS program administrators, notified the FDA of these technical issues; the issues have been resolved as of October 16, 2015. However, if prescribers and pharmacists continue to experience any issues, they are advised to use clinical judgment, consider the best interests of the patient, and to continue prescribing and dispensing clozapine to patients with an with an absolute neutrophil count (ANC) within the acceptable ranges until the issues are fully resolved.
Prescribers or pharmacists who continue to encounter technical issues with the Clozapine REMS Program should contact the Clozapine REMS Contact Center at (844) 267-8678. Clozapine manufacturers have also posted additional information on the Clozapine REMS website regarding the program requirements.
Starting October 12, 2015, the FDA required changes to prescribing information for clozapine and a new shared REMS due to continuing safety concerns and current knowledge regarding the risk of severe neutropenia.
For more information call (888) 463-6322 or visit FDA.gov.