Although clinicians and advocates applauded the US Food and Drug Administration (FDA)’s recent decision to discontinue a risk management and evaluation program for the antipsychotic clozapine ...
By Ellen Barry The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant ...
The FDA has eliminated the need for pharmacists to verify a patient's white blood cell count before dispensing the antipsychotic medication clozapine.
The FDA still recommends prescribers monitor patients’ ANC levels according to the prescribing information. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation ...
Following the advice of a nearly unanimous joint FDA advisory committee, the agency decided that clozapine's REMS program is no longer necessary to ensure that the benefits of the drug outweigh ...
FDA Makes Access to Clozapine Easier for Patients With Schizophrenia By Stephanie Brown HealthDay Reporter FRIDAY, Feb. 28, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
Neutropenia is a rare side effect of clozapine, and severe cases can be life-threatening. The blood test was a necessary part of a regimen known as risk evaluation and mitigation strategies ...
One in 3 people with schizophrenia don’t respond to antipsychotics — but previous blood test requirements made clozapine difficult to access. The FDA removed a requirement for patients to ...
A new study published in the European Journal of Obstetrics, Gynecology, and Reproductive Biology showed that urinary ...
The FDA removed a requirement for patients to submit blood test results before receiving the schizophrenia drug clozapine.