Drugs

Remove Contrast Agent Boxed Warning: ICUS

The International Contrast Ultrasound Society (ICUS) is asking FDA to remove Boxed Warnings from ultrasound contrast agent (UCA) labels “in order to bring the labeling into line with the current body of scientific research, which now clearly demonstrates the favorable safety profile and clinical benefits of these radiation-free diagnostic imaging products.” The group’s petition says that the agency first required Boxed Warnings on UCAs in 2007 following spontaneous reports of serious adverse events (SAEs) that occurred after UCA administration. “However,” it says, “the SAEs were not contemporaneously adjudicated and some were later attributed to underlying medical conditions and/or medication. Since 2007, peer-reviewed publications have consistently shown that UCAs are exceedingly safe, efficacious, and save lives. Indeed, the most current safety data convincingly show that UCAs are among the safest diagnostic imaging products available.

ICUS says Boxed Warnings are appropriate only as an indicator of the very highest level risk associated with FDA-approved products. “This extreme level of risk is simply not presented by the use of UCAs, and ICUS is deeply concerned that the current Boxed Warnings unduly deter the use of UCAs when medically indicated, to the detriment of our patients,” the organization says. It recommends that appropriate warnings should be included in the Warnings and Precautions section of UCA labels, without a black box.

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