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DRUG REACTIONS US clozapine registry saves lives The national clozapine registry system in the US appears to have contributed to lower than expected rates of clozapine-induced agranulocytosis and associated deaths, says Dr Gilbert Honigfeld from New Jersey. In the US, clozapine is distributed through a national registry system developed and maintained by the US manufacturer of the agent. The registry ensures that clozapine is provided to patients only if weekly blood tests show no evidence of significant suppression of white blood cells. From the time when clozapine was introduced in the US in February 1990 until December 1994,99502 patients received clozapine in the US. During this period, there were 382 cases of agranulocytosis (crude incidence rate 0.38%) and 12 deaths associated with agranulocytosis (0.012%). These incidences were lower than expected based on premarketing clinical research: 955 cases of agranulocytosis and 149 deaths were expected. According to Dr Honigfeld, 'these data show that current medical practice and monitoring procedures have contributed substantially toward saving the lives of many patients who require clozapine therapy. ' Honigfeld O. Effects of the c10zapine national registty system on incidence of deaths related to agranulocytosis. Psychiatric Services 47: 52-56, Jan 1996 800119341 0156-270319611022-00021/$01.00° Adia International Limited 1996. All rlghtB reaerved 21 INPHARMA e 3 Feb 1996

US clozapine registry saves lives

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Page 1: US clozapine registry saves lives

DRUG REACTIONS

US clozapine registry saves lives The national clozapine registry system in the US

appears to have contributed to lower than expected rates of clozapine-induced agranulocytosis and associated deaths, says Dr Gilbert Honigfeld from New Jersey.

In the US, clozapine is distributed through a national registry system developed and maintained by the US manufacturer of the agent. The registry ensures that clozapine is provided to patients only if weekly blood tests show no evidence of significant suppression of white blood cells.

From the time when clozapine was introduced in the US in February 1990 until December 1994,99502 patients received clozapine in the US. During this period, there were 382 cases of agranulocytosis (crude incidence rate 0.38%) and 12 deaths associated with agranulocytosis (0.012%). These incidences were lower than expected based on premarketing clinical research: 955 cases of agranulocytosis and 149 deaths were expected.

According to Dr Honigfeld, 'these data show that current medical practice and monitoring procedures have contributed substantially toward saving the lives of many patients who require clozapine therapy. ' Honigfeld O. Effects of the c10zapine national registty system on incidence of deaths related to agranulocytosis. Psychiatric Services 47: 52-56, Jan 1996 800119341

0156-270319611022-00021/$01.00° Adia International Limited 1996. All rlghtB reaerved

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INPHARMAe 3 Feb 1996