Drugs

FDA Removes Clozapine REMS Program

FDA has removed a risk evaluation and mitigation strategies (REMS) program for clozapine, which required healthcare professionals to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense the drug. The decision to remove the REMS is in line with an 11/20/2024 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee, in which members decided that the clozapine REMS was no longer necessary.

Under this latest action, FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. “Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings,” it says. The agency also believes that eliminating the REMS is expected to decrease the burden on the healthcare delivery system and improve access to clozapine.

Manufacturers are being notified on the action and instructed to formally submit a modification to eliminate the clozapine REMS and to update the prescribing information, including removing mandatory reporting of ANC blood tests to the REMS program, the notice says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome