Drugs

Ban UHDU Opioid Analgesics: Groups

Six groups are petitioning FDA to seek removal of oral and transmucosal ultra-high dosage unit (UHDU) opioid analgesics from the market. The groups — Association of State and Territorial Health Officials, National Safety Council, Physicians for Responsible Opioid Prescribing, American College of Medical Toxicology, FED UP! Coalition to End the Opioid Epidemic, and Shatterproof: Stronger Than Addiction — say that “the harms of UHDU orally administered opioid analgesics outweigh the modest benefit of allowing patients to swallow fewer tablets or capsules. When utilizing the new benefit-risk framework that takes into account inappropriate use, the need for removal of UHDU becomes even more clear. UHDU opioids should be immediately removed from the market to prevent further harm to thousands of adults, adolescents, children, and toddlers.”

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