Drugs

Alert on B.Braun Microbore Extension Sets

FDA says B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market because their labels show incorrect information about the device’s filter. Specifically, the product label shows that the device contains an air-eliminating filter, but an FDA alert says the filter used on the extension sets does not feature an air vent and is not indicated for removing air.

“If during use there is air within the line or filter itself, the air can occlude the filter,” the alert says. “This could lead to a significant delay in therapy with significant impact on patient condition (e.g. with life-sustaining drugs). It is possible for air to escape the filter and enter the patient where embolization could occur. This could lead to patient harm up to and including permanent organ damage or death.”

The extension sets are single-use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products, the alert 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