Drugs

Kidney Risk in OTC Weight Loss Drug Alli

FDA has approved changes to the Drug Facts label of Haleon’s over-the-counter weight loss drug alli (orlistat) to warn of the risk of acute kidney injury, which the agency says is a rare side effect of the drug. An FDA statement says the new labeling advises consumers to ask a healthcare provider before using alli if they have ever had kidney disease or kidney stones. Consumers are also cautioned to stop using alli and ask a doctor if they develop symptoms of kidney injury or kidney stones. FDA says the risk of kidney injury is now described consistently across the labeling for both over-the-counter and prescription orlistat products.

The notice says FDA received periodic safety reports of acute kidney injury associated with alli, which led to a reevaluation of the safety signal for the OTC product. It says a search of the FDA Adverse Event Monitoring System and the medical literature identified 12 cases of kidney complications associated with alli use from its 2/9/2007 approval through 12/21/2023. The agency says the severity of the cases was “substantial,” with eight patients requiring hospitalization and five needing dialysis.

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