Drugs

Latest Safety Signal Report Includes Ozempic, Others

An FDA report on new safety signals seen in the FDA Adverse Event Reporting System between 7/2023 and 9/2023 includes reports of hair loss, aspiration, and suicidal ideation in some people using the popular GLP-1 receptor agonists like Novo Nordisk’s Ozempic (semaglutide), Wegovy (semaglutide), and Rybelsus (semaglutide); its Saxenda (liraglutide) and Victoza (liraglutide); and Lilly’s Mounjaro (tirzepatide) and Zepbound (tirzepatide).

The agency notes that a safety signal does not necessarily mean a causal connection between the drug and the adverse event, and says it is considering whether regulatory action is needed, the same response it has for most of the 17 other listings in the report.

When asked by CNN for a 1/3 comment, the agency said, “FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process. If newly identified safety signals are identified, FDA will determine what, if any, actions are appropriate after a thorough review of available data.”

The cable television news network says some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis, and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs’ prescribing information or on their labels it says.

Novo Nordisk told CNN that it “stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”

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