TY - JOUR
T1 - FDA changes clozapine monitoring guidelines
T2 - Implications for worldwide practice
AU - Bastiampillai, Tarun
AU - Gupta, Arun
AU - Allison, Stephen
PY - 2016/6/1
Y1 - 2016/6/1
N2 - US FDA decision to change their clozapine monitoring guidelines in 2015 for the first time. The changes proposed are as follows: lowering the neutrophil count before ceasing clozapine from 1.5 to 1.0 × 109/l, allowing the potential for re-challenge following severe neutropenia (<1.0 × 109/l) and allowing those with benign ethnic neutropenia the opportunity to be commenced on clozapine. These changes will allow a greater number of patients with schizophrenia in USA to be continued on clozapine. In our correspondence we summarize the evidence that support these changes. The FDA changes will likely have impact on clozapine monitoring protocols in other countries.
AB - US FDA decision to change their clozapine monitoring guidelines in 2015 for the first time. The changes proposed are as follows: lowering the neutrophil count before ceasing clozapine from 1.5 to 1.0 × 109/l, allowing the potential for re-challenge following severe neutropenia (<1.0 × 109/l) and allowing those with benign ethnic neutropenia the opportunity to be commenced on clozapine. These changes will allow a greater number of patients with schizophrenia in USA to be continued on clozapine. In our correspondence we summarize the evidence that support these changes. The FDA changes will likely have impact on clozapine monitoring protocols in other countries.
KW - Agranulocytosis
KW - Benign ethnic neutropenia
KW - Clozapine monitoring protocol
KW - US FDA
UR - http://www.scopus.com/inward/record.url?scp=84959377700&partnerID=8YFLogxK
U2 - 10.1016/j.ajp.2016.01.012
DO - 10.1016/j.ajp.2016.01.012
M3 - Letter
C2 - 27208449
AN - SCOPUS:84959377700
VL - 21
SP - 19
EP - 20
JO - Asian Journal of Psychiatry
JF - Asian Journal of Psychiatry
SN - 1876-2018
ER -