Drugs

No Clarity Yet on Ozempic Suicide Risk: FDA

FDA says it is continuing to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. An agency drug safety update says its preliminary evaluation does not suggest a causal link, but such a link also cannot be definitively ruled out, given the small number of occurrences recorded in clinical trials of the drugs. The notice says the drugs are used to treat patients with Type 2 diabetes or to help with weight loss.

The agency says it has conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs,” FDA says. “Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”

FDA says its additional analyses will include a meta-analysis of clinical trials across all GLP-1 RA products and an analysis of postmarketing data in the Sentinel System. “We will communicate our final conclusions and recommendations after we complete our review or have more information to share,” the agency 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

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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