Drugs

FDA Mulls REMS for Immediate Release Opioids: Woodcock

CDER director Janet Woodcock says that FDA is considering whether to add immediate-release opioids to the REMS program that is in place for extended-release/long-acting opioids. Speaking in a Director’s Podcast, Woodcock also says the agency will be expanding its view on things that a practitioner should be trained on, to include pain management, so that clinicians can better determine whether to write a prescription for an immediate-release opioid or perhaps offer some other kind of treatment or pain management intervention that could have fewer liabilities. “So we are definitely thinking about how we can make sure that practitioners are trained on pain management and aren’t just automatically reaching for the prescription pad every time people come in with a complaint of pain,” she said.

In other comments, Woodcock reviewed labeling changes that have been made, including a Boxed Warning dealing with the inherent risks of immediate-release products. The agency also added a Warning about using benzodiazepines with opioids. “Both of these have respiratory depression characteristics, and an overdose, if people take too many of both of them, could increase the risk of very serious problems, including death,” she said.

More information also was added to the label to tell pregnant women of the need to be on treatment for their opioids and not abusing opioids during their pregnancy because of the risk of neonatal opioid withdrawal syndrome, she said.

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