Drugs

Alert on Compounded Moxifloxacin Ophthalmic Solutions

An FDA drug safety alert is warning about reports of toxic anterior segment syndrome (TASS) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged or diluted FDA-approved moxifloxacin. The agency has identified 29 cases that described TASS associated with moxifloxacin’s intraocular administration, with most of these occurring after cataract surgery.

The alert notes that moxifloxacin topical ophthalmic solutions (marketed under Moxeza and Vigamox brands) are not FDA approved for intraocular administration. “FDA is aware of multiple literature reports that claim to support the use of intraocular moxifloxacin for the prophylaxis of endophthalmitis, and it is a common practice among ophthalmologists in association with cataract surgery,” it says. “However, there are no adequate and well controlled studies that demonstrate moxifloxacin’s efficacy for treating endophthalmitis.”

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