Drugs

Change Buprenorphine Labeling: Petition

The Colorado Society of Addiction Medicine, supported by similar societies in eight states, is calling on FDA to update the labeling of sublingual buprenorphine products to treat opioid use disorder. The society petition wants the labeling to indicate that following initiation, the buprenorphine dose should be titrated based on the prescriber’s clinical judgment to alleviate symptoms enough to enable patients to maintain discontinuation of illicit opioid use.

The society says the labeling should indicate that evidence suggests that 16 mg/day or more may reduce the risk of overdose death more effectively than lower doses.

The petition also asks FDA to issue a drug safety communication to providers highlighting the potential clinical benefit of sublingual buprenorphine doses equal to or greater than 16 mg/day in patients with opioid use disorder.

“Current labeling for sublingual and/or buccal buprenorphine products is inadequate to meet the needs of the American population during a synthetic opioid overdose epidemic,” the society 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