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.
You may also be interested in...
Novartis Clozaril, Generic Registry Merger Could Clarify Potential Risk
Combining Novartis' Clozaril white blood cell patient registry with generic clozapine databases could provide a clearer picture of the potential risk of moving to a less frequent monitoring schedule, FDA's Psychopharmacologic Drugs Advisory Committee agreed June 16
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011