Drugs

Remove Suicide Warning from GLP-1 Drugs: FDA

FDA says its evaluation did not find an increased risk of suicidal ideation or behavior in patients using glucagon-like peptide-1 (GLP-1) receptor agonist medications and thus companies should remove statements on suicidal ideation or behavior from the labeling. An agency statement says the affected products are Novo Nordisk’s Saxenda (liraglutide) and Wegovy (semaglutide), and Lilly’s Zepbound (tirzepatide).

The notice says the labeling changes follow a “comprehensive FDA review that found no increased risk of suicidal ideation or behavior associated with the use of GLP-1 RA medications.”

At the time the three drugs were approved for a weight loss indication, FDA says, the labeling for each of the products included information in the Warnings and Precautions section about the potential risk of suicidal ideation and behavior.

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