FDA grants monthly safety checks for Alamo Pharma drug

Like all products containing the active ingredient clozapine, including Novartis’ Clozaril, treatment with FazaClo is monitored prior to filling each prescription and refill in order to limit the risk of agranulocytosis, a rare but serious side effect that affects the blood. As each FazaClo patient’s blood tests show acceptable white blood cell counts, the data is arrayed in the computerized FazaClo patient registry database, and the patient’s pharmacist then releases the next prescription.

Acting on a review of long-term patient data showing that the rare blood effect most often appears during the first 12 months of treatment, the monthly monitoring schedule relieves patients and care providers of the need for weekly or bi-weekly testing once the patient has had 12 continuous months of acceptable WBC (white blood cell counts).

Alamo also said that it believes this regulatory action shows expanded confidence in the safety of FazaClo as an alternative for the treatment of previously unresponsive patients with schizophrenia.