Drugs

FDA Approves Boxed Warning on Canagliflozin

FDA has approved a new Boxed Warning on canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) based on recent safety data (see earlier story) that indicate it causes an increased risk of leg and foot amputations. A recent drug safety communication recommends that patients taking the drug notify their healthcare professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. The notice also says that in the CANVAS trial, the risk of amputation was 5.9 out of every 1,000 patients treated with canagliflozin and 2.8 out of every 1,000 treated with placebo, while in the CANVAS-R study, it was 7.5 out of 1,000 treated with canagliflozin and 4.2 out of every 1,000 treated with placebo. To view the revised labeling, click here.

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