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Neutropenia Risk Prompts REMS for Antipsychotic Clozapine

clozapinelabelThe Food and Drug Administration (FDA) has announced changes to prescribing information for the atypical antipsychotic clozapine and a new shared risk evaluation and mitigation strategy (REMS) due to continuing safety concerns and current knowledge regarding the risk of severe neutropenia. Clozapine is indicated for the treatment of resistant schizophrenia and to reduce the risk of recurrent suicidal behavior in schizophrenia and schizoaffective disorders.

The requirements to monitor, prescribe, dispense, and receive clozapine are now incorporated into the new shared Clozapine REMS Program, which replaces the six individual clozapine registries. The REMS program includes all clozapine medicines in order to provide a centralized point of access for prescribers and pharmacists in managing the risk of neutropenia. Starting October 12, 2015, clozapine will be available only through the Clozapine REMS Program.

Important changes to the neutropenia monitoring recommendations and treatment algorithm for clozapine include:

  • Absolute neutrophil count (ANC) is the only test result accepted in the Clozapine REMS Program to monitor for neutropenia.
  • If the patient is an outpatient, the ANC must be reported to the Clozapine REMS Program before clozapine is dispensed.
  • If the patient is an inpatient, the ANC must be reported within 7 days of the most recent blood sample.
  • Patients with benign ethnic neutropenia (BEN) can now be treated with clozapine.

This article originally appeared on MPR.

The Pope’s Visits with President Obama Highlights the Pope’s Blessing of Ariana-Leilani

Pope Francis blesses Ariana-Leilani at the Vatican

Pope Francis blesses Ariana-Leilani at the Vatican

As a followup to Pope Francis’s blessing of Ariana-Leilani, in his meeting with Dr. Ariel Rosita King at the Vatican, urging Ariana-Leilani’s safe liberation from abuse, neglect and potentially fatal illness, the Pope has arrived in Washington DC to deliver his message to uplift those who are persecuted and the poor.

We hope that President Obama listens to his messages, and finally takes actions to protect Ariana-Leilani who lives several blocks from the White House in Washington, DC.

Please sign the petition to Save Ariana-Leilani and make Pope Francis’ blessings and wishes a reality.GoPetition

Pope Francis Blesses Ariana-Leilani

Pope Francis blesses Ariana-Leilani at the Vatican

Pope Francis blesses Ariana-Leilani at the Vatican

On a historical occasion, Pope Francis blessed Ariana-Leilani, in his meeting with Dr. Ariel Rosita King urging Ariana-Leilani’s safe liberation from abuse, neglect and potentially fatal illness.   Before an audience of thousands at the Vatican, he placed his hand upon her picture and gave his blessings after hearing her tragic story.   Please sign the petition to Save Ariana-Leilani and make Pope Francis’ blessings and wishes a reality.

 

GoPetition