Novartis Clozaril blood monitoring frequency decrease after six months recommended by FDA committee.

Executive Summary

CLOZARIL BIWEEKLY BLOOD TESTS WOULD LEAD TO .4 MORE AGRANULOCYTOSIS CASES per 1,000 patient-years after six months of therapy compared to the current weekly blood cell monitoring schedule, according to a registry analysis presented by Novartis to FDA's Psychopharmacologic Drugs Advisory Committee July 14. The committee unanimously recommended the less frequent blood sampling after six months and voted 7-3 to allow monitoring after one year of therapy to be voluntary. No recommendation was made for when to discontinue blood cell counts for the antipsychotic.