Drugs

Shorter Antibiotic Use Effective in 2 Uses: Studies

Research funded by FDA through the Johns Hopkins University School of Medicine under the National Action Plan for Combating Antibiotic-Resistant Bacteria has demonstrated that shorter courses of antibiotics were as effective as longer courses in two specific study populations, reducing the chance for antibiotic resistance. An FDA online paper says the studies “demonstrated the feasibility and advantages of a novel automated approach for extracting patient-level data from electronic health records to capture treatment outcomes in diverse real-world health settings. The results provide valuable evidence to inform best practices related to the duration of antibiotic treatment in diverse bacterial infections, optimizing patient outcomes while reducing the risk for antimicrobial resistance.”

Researchers developed an automated approach for extracting patient-level data from Epic electronic health record software in five hospitals in the Johns Hopkins Health System. “This novel approach enhances access to the multicenter data needed to capture clinical practice and patient experience, streamlines analyses, and defends against breeches of patient privacy,” the paper says.

The researchers used the data extracted from electronic health records to investigate antibiotic treatment optimization in Pseudomonas aeruginosa bloodstream infections in adults and pyelonephritis in children.

“The approaches used in these studies for extracting patient data to compare treatment outcomes in real-world settings promise to assist FDA in future efforts to analyze large clinical databases,” the report concludes.

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