Serious Issues With Slow Heartbeat Flagged for Afib Patients on Antiarrhythmics
Old concerns about the safety of rhythm control drugs for atrial fibrillation (Afib or AF) resurfaced in a contemporary large Korean population-based study. Afib patients prescribed antiarrhythmic drugs (AADs) had several-fold higher risks of cardiac events believed to be related to a decline in heart rate. Compared with other Afib patients, these AAD users showed […]
No Increased Risk of Suicidal Ideation With GLP-1 Drugs
Despite recent concerns to the contrary, semaglutide (Wegovy, Ozempic) carried a lower risk of suicidal ideation in patients with obesity or type 2 diabetes, according to retrospective analyses of the two patient populations. An analysis of 240,618 patients who were overweight or obese showed that those taking semaglutide — a glucagon-like peptide 1 (GLP-1) receptor […]
FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy
FDA reviewers voiced serious concerns about the investigational amyotrophic lateral sclerosis (ALS) treatment debamestrocel — mesenchymal stromal cells secreting neurotrophic factors, also known as MSC-NTF, or NurOwn — from BrainStorm Cell Therapeutics ahead of an advisory committee meeting this week. When the FDA first received the drug’s application for approval, it determined the submission was […]
FDA Reviewers Have Concerns About Artificial Womb Trials in Humans
FDA staff raised concerns that need to be addressed prior to potential human tests of artificial womb technology (AWT), a device that simulates a womb for extremely premature infants, as detailed in briefing documents released ahead of a Pediatric Advisory Committee meeting next week. AWT devices are intended to treat extremely premature infants, who have […]
FDA Reviewers Raise Multiple Issues on OTC Birth Control Pill
FDA staff raised concerns over the prospect of a contraceptive pill for over the counter (OTC) use, and questioned whether sufficient evidence exists that consumers would take the pill appropriately, according to briefing documents released ahead of a 2-day advisory committee meeting. At a joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, […]
Proposed User Instructions for OTC Narcan Has FDA Concerned
Ahead of an advisory committee meeting, FDA staff highlighted ongoing concerns about labeling for what could possibly be the first naloxone (Narcan) product approved for over-the-counter (OTC) use, labeling it “essential” in the emergency setting of an overdose. At a joint meeting of the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory […]
WHO Renames Monkeypox As Mpox, Citing Racism Concerns
LONDON (AP) — The World Health Organization has renamed monkeypox as mpox, citing concerns the original name of the decades-old animal disease could be construed as discriminatory and racist. The U.N. health agency said in a statement Monday that mpox was its new preferred name for monkeypox, saying that both monkeypox and mpox would be […]
Doc Groups Unhappy With 4.5% Cut in the 2023 Medicare Fee Schedule Final Rule
WASHINGTON — Physician groups expressed concerns over what one group called a “substantial” decrease in Medicare fee-for-service physician payments under a final rule for 2023 issued Tuesday by the Centers for Medicare & Medicaid Services (CMS). The 2023 Medicare Physician Fee Schedule includes a 4.5% decrease in the conversion factor — the multiplier that Medicare […]
Making Low-Dose tPA Work for Japanese DOAC Users With Ischemic Stroke
Despite concerns about the potential bleeding risk, IV thrombolysis could be safely given to ischemic stroke patients within a day of direct oral anticoagulant (DOAC) therapy, according to observational data from Japan. Between DOAC users and peers not taking oral anticoagulants within 48 hours of stroke onset, rates of symptomatic intracranial hemorrhage, accompanied by a […]
ACOs Fight Looming Cuts, Privatization Rhetoric
WASHINGTON — CMS officials responded to concerns from accountable care organization (ACO) leaders about growth, a substantial pending payment cut, and ideological opposition, speaking at the meeting of the National Association of ACOs (NAACOS) here last week. During a question-and-answer session with CMS Administrator Chiquita Brooks-LaSure, NAACOS CEO Clif Gaus, ScD, said the administration’s goal […]