Drugs

Alert on Compounded Semaglutide Overdoses

FDA has issued a warning about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. “Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug,” an FDA drug safety alert says. Semaglutide is the active ingredient in Novo Nordisk’s diabetes drug Ozempic and its weight-loss drug Wegovy.

The agency says that many of the patients who receive vials of compounded semaglutide lack experience with self-injections. “Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and units) may have contributed to dosing errors,” it says.

The alert urges healthcare providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe. “Additionally, healthcare providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available,” it 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