Drugs

FDA Alert on Compounded Topical Finasteride

FDA says it is aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. An agency alert says FDA has approved two oral finasteride products for different indications — Organon’s Proscar and Propecia. “Currently, there is no FDA-approved topical formulation of finasteride,” it says. “Compounded topical finasteride products do not have FDA-approved labeling. There are potential serious risks associated with the use of compounded topical finasteride products.”

The alert says 32 cases were reported to the FDA Adverse Event Reporting System between 2019 and 2024. Reports covered adverse events consistent with the approved oral finasteride products including erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain. Most of the reports said the adverse effects continued even after drug use was stopped, FDA says. Some consumers said they were unaware of potential adverse effects, while others said their prescriber said there was no adverse effect risk since the product was topical.

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