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FDA puts clozapine REMS requirements on temporary hold

FDA said it is temporarily halting its risk evaluation and mitigation strategy (REMS) program for clozapine, a treatment for schizophrenia.

FDA noted that health care professionals have had difficulty trying to adhere to the program’s original November 15 deadline. The agency confirmed that pharmacists can dispense clozapine without a REMS dispense authorization and wholesalers can continue to ship clozapine to pharmacies and other health care settings.

“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” FDA stated.

In July 2021, FDA approved modifications to the clozapine REMS. The drug can be effective in some patients, but it can also potentially decrease a person’s neutrophil count, which can lead to severe neutropenia, serious infections, and possibly death. Patients who take the drug need to have their absolute neutrophil count monitored.

FDA said medical professionals informed the agency about ongoing challenges such as a high call volume and long call wait times for stakeholders. FDA recommended the use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range. In September, the American Psychiatric Association and other groups asked FDA in a letter to delay the implementation of a new REMS program until after January 1, 2022.

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