Drugs

Aurobindo Recalls Healthy Living Migraine Relief

FDA says Aurobindo Pharma recalled 7/18 one lot of its Healthy Living OTC Migraine Relief (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) due to a missing manufacturer label. The agency announcement says the company began shipping the affected batch to customers nationwide in January. Some bottles without a label were inadvertently supplied to Amazon, it says, and Amazon placed an Amazon sticker on the bottles (without the agency filed and approved label) and distributed the product to end users.

“As a result,” Aurobindo says, “the product lacks the required over-the-counter labeling information, drug facts, and patient usage information. There is significant risk of misuse, which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient, which could be life-threatening. To date, Aurobindo has not received any reports of adverse drug events that are confirmed related to this recall.”

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