Drugs

FDA ‘Proactive Pharmacovigilance’ on Opioids

FDA says it is committed to using a multi-component system of pharmacovigilance to be able to intervene proactively and effectively in anticipation of changes in drug abuse. Writing in a New England Journal of Medicine Perspective column, three agency senior executives describe pharmacovigilance steps taken involving gabapentinoids, the botanical kratom, and over-the-counter loperamide.

“FDA faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” writes FDA commissioner Scott Gottlieb and two colleagues. “Some changes could be appropriate, such as the use of gabapentinoids instead of opioid analgesics for selected pain conditions in appropriate patients. But we are also seeing a shift away from the use of prescription opioids toward plant materials containing unrecognized opioids or to OTC products with potentially lethal opioid effects. In other cases, nonopioid drugs such as gabapentinoids are being prescribed, alone and in combination with opioids, and the consequences of those uses are under close investigation…. The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

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