Drugs

Clozapine REMS Updated

FDA says it has approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for clozapine (Novartis’ Clozaril), an antipsychotic drug used to help improve symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. The changes take effect 2/28 and include a requirement that healthcare professionals prescribing clozapine, as well as pharmacies dispensing it, be certified in the clozapine REMS program.

An agency announcement says that while the drug is beneficial for some patients, there are risks associated with it, Specifically, it says, clozapine can decrease the number of neutrophils that function in the body to fight infection. For that reason, FDA says, patients taking clozapine need to have their absolute neutrophil count monitored regularly. That monitoring requirement is the basis for the clozapine REMS.

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

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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