Drugs

Warning on Skin-Cap Spray Products

FDA says Chemigroup France (formerly known as Cheminova Laboratories) is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids. The products, which are found at skincap.com, amazon.com, and walmart.com, are marketed for treating psoriasis, seborrheic dermatitis and typical eczema, painful lichen, skin redness, dandruff, itching and irritation of the skin. An agency notice is warning that the products should not be used because they may be harmful to public health.

“FDA testing identified a high-potency glucocorticosteroid (immunosuppressive and anti inflammatory drugs) in Skin-Cap aerosol spray products that is not disclosed on the label or packaging,” the notice says. “Additionally, long-term use of topical corticosteroids, like glucocorticosteroids, cav cause health problems such as skin thinning (atrophy) and skin reactions, and if used on large body areas may lead to increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and changes in hormone levels (adrenal dysfunction).”

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