Drugs

EMA Committee Dismisses GLP-1 Suicidality Risk

As FDA continues 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, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 4/12 concluded that available evidence does not support a causal association. The drugs are used to treat Type 2 diabetes and obesity-related weight management under certain conditions in adults who are obese or overweight.

Earlier this year, an FDA drug safety update said its preliminary evaluation did not suggest a causal link, but such a link also could not be definitively ruled out, given the small number of occurrences recorded in clinical trials.

The EMA committee says that part of its review analyzed the results of a recent study, based on a large database of electronic health records, which investigated the incidence of suicidal thoughts in patients treated with semaglutide (Ozempic and Wegovy) or other non-GLP-1 receptor agonist medicines for diabetes or weight loss. The study found no causal association between the use of semaglutide and suicidal thoughts, it says. Another study was conducted by EMA, based on electronic health records, which also did not support a causal association between the use of GLP-1 receptor agonists and the risk.

"After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC considers that no update to the product information is warranted,” EMA 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