Drugs

FDA Lays Out Unapproved GLP-1 Drug Concerns

FDA says it is aware that some patients and healthcare professionals may look to unapproved GLP-1 drugs (including semaglutide and tirzepatide) as an option for weight loss. “This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness, and quality before they are marketed,” an agency statement says.

The statement discusses the agency’s concerns with compounded versions of the drugs, saying it is aware of fraudulently compounded GLP-1 drugs marketed in the U.S. that contain false information on the product label. “In some cases,” the notice says, “the compounding pharmacies identified on the labels of the products do not exist. In other cases, the labels of the fraudulent compounded medicine contain the name of a licensed pharmacy that, based on information FDA has gathered, did not compound these products.” It also covers dosing concerns with the compounded products.

The agency says that as of 4/30, it had received 520 reports of adverse events associated with compounded semaglutide and 480 reports for compounded tirzepatide.

The statement also covers illegally marketed versions of the drugs, including counterfeit Ozempic (semaglutide), illegal online sales of the drugs, and versions sold falsely for research purposes or not for human consumption.

FDA recommends that patients obtain a prescription from their doctor and then fill it at a state-licensed pharmacy.

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