Drugs

FDA Warning on Unapproved Molluscum Treatments

FDA has issued a warning against using unapproved products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.” The agency notes that there are no FDA-approved products to treat molluscum.

FDA says that any unapproved products marketed to treat molluscum will likely not work, and the ingredients in them could cause adverse effects. “The FDA has received reports of side effects in children and adults associated with some of these products, including skin reddening, abrasion from skin scratching, and permanent scarring,” it says. Many of these unapproved products claiming to treat molluscum contain essential oils, which may cause an allergic reaction or irritate sensitive skin, it adds.

Molluscum, also called water warts, is a viral infection that can cause white, pink or flesh-colored bumps, FDA says, adding that it eventually goes away on its own without treatment, usually in six to 12 months. “If you have molluscum, a skin doctor (dermatologist) or other health care professional can evaluate your symptoms and recommend ways to manage your condition,” 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