Drugs

FDA Alert on Canagliflozin Associated with Amputations

FDA has issued a drug safety alert on Janssen’s diabetes medicines containing canagliflozin (Invokana and Invokamet) after data from an ongoing clinical trial showed an increase in leg and foot amputations, mostly affecting the toes. The ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) identified amputations that occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo.

The agency says it has not determined whether canagliflozin increases the risk of leg and foot amputations, and it is currently investigating the incidents. For now, FDA says that healthcare professionals should follow the recommendations in the canagliflozin drug labels, and monitor patients for any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

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