Search Results for 'REMS'

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Product: Clozapine
Company: Various
Petition Filer: David Behar, MD
Petition Number(s): 2012P-0379
Date of Petition: May 2, 2012
Responding Petitions:

Issue and Implication: Whether a label can be changed through the petition process.

Action Requested by Petitioner: The Petitioner is asking FDA to create an exception in the clozapine label for certain types of patients and to create a national registry of these patients.

Summary of Petition(s): Petitioner is a psychiatrist who treats patients with schizophrenia. He has observed that some of his patients who are of African or Mediterranean descent often have low white blood cell counts and low absolute neutrophil counts. These counts are often low for these populations. Clozapine has proven to be an effective, though sometimes last resort, treatment for schizophrenia. However, it has a black box warning regarding these counts where therapy must be discontinued if they get too low.

Petitioner points out that his patients often do well on clozapine therapy but need to be removed if their counts get too low even though it may be normal for them. So, he is asking FDA to create an exception in the label to allow patients of this ethnic background to continue clozapine therapy. In support of this request, he offers literature that points to clozapine effectiveness, the dangers of sudden cessation of clozapine therapy, and differences in ethnic groups.

On February 27, 2013, Petitioner submitted a letter asking for an answer.

FDA Action: On May 17, 2016, FDA withdrew this petition.

Citizen Petition
Petitioner Letter
Petition Withdrawal

Special Note: On March 30, 2020, this same Petitioner filed another petition regarding clozapine, asking for the FDA to remove the product’s REMS requirements (2020P-1073). While posted here, we will not follow it to resolution.
Citizen Petition (2020P-1073)

Product: Clozapine
Company: Various
Petition Filer: Genesee Health System
Petition Number(s): 2014P-1622
Date of Petition: October 15, 2014
Responding Petitions:

Issue and Implication: Whether a REMS program can be changed when they adversely affect certain patient populations.

Action Requested by Petitioner: The Petitioner is asking FDA to amend the REMS (Risk Evaluation and Mitigation Strategy) to allow the start of clozapine therapy if White Blood Cell (WBC) count is > 3000mm(3) which is due to benign ethnic neutropenia (BEN).

Summary of Petition(s): Current REMS for clozapine require that White Blood Cell (WBC) count is greater than 3500mm(3). It also requires cessation of the therapy if WBC or their absolute neutrophil count (ANC) decreases. The problem with the REMS is that some patient populations (African-Americans, eg) have a condition where their WBC and ANC are usually lower than Caucasian patient populations. This condition is benign, and hence has the designation benign ethnic neutropenia (BEN).

Petitioner is in a location that sees a large number of African-American patients and would like to start the appropriate candidates on clozapine but cannot for some of them due to their BEN. The current REMS also requires some who have started to stop therapy unnecessarily. So, it is asking to allow to start patients with a WBC of greater than 3000mm(3) and stop therapy if WBC drops below 2500mm(3) or ANC below 1000mm(3). Of course, the request changes the range for BEN patients which should not increase risk. These guidelines also mimic those used in the UK.

FDA Action: On October 6, 2015, Petitioner withdrew this petition.

Citizen Petition
Petition Withdrawal

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