FDA Removes Mandatory Blood Test Monitoring For People Taking Antipsychotic Clozapine

Starting February 24, 2025, the U.S. Food and Drug Administration (FDA) removed mandatory blood test monitoring for people taking the antipsychotic clozapine. Previously, the FDA had required people taking clozapine to participate in its Risk Evaluation and Mitigation Strategy (REMS) program, a drug safety program for certain medications with serious safety concerns to ensure the benefits of the medication outweigh its risks. A REMS program focuses on preventing, monitoring, and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or event severity.

Marketed as Clozaril, Fazaclo ODT, Versacloz, and generics . . .