Drugs

Medical Device Recalls Up, Drugs Down: Sedgwick

The Sedgwick Recall Index says that for the third quarter of 2024, U.S. medical device recall events increased 8.3% from 242 in the second quarter to 262. The increase means that 2024 is on track to reach a three-year high, the Sedgwick report says.

Device failure was the leading cause of recall activity in the third quarter, accounting for 43 events (16.4%). It was the third continuous quarter of growth in this cause, setting a five-year high. Sedgwick says the total affected units fell 19.1% from 196.2 million to 158.7 million. The report says that only one year in the last 20 recorded more affected units.

On the drug side, recall events dropped 24.7% from 93 in the second quarter to 70 in the third quarter. Failed specifications were the leading cause of third-quarter recalls, accounting for 17 events (24.3%). The new two causes were mislabeling and contamination, with eight recalls each. Sedgwick says the total affected units rose 80.2% from 4.5 million in the second quarter to 8.2 million in the third quarter. Despite that increase, it says, the total number of affected units year-to-date is at an eight-year low.

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