FDA Safety Labeling Update — BRIVIACT (brivaracetam)
Source: FDA Drug Safety-related Labeling Changes database (BRIVIACT entry). FDA Access Data Last update What changed (high-level) The August 28, 2025 supplement adds a new safety subsection describing Serious Dermatologic Reactions (including Stevens–Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) and updates related adverse reaction and patient counseling sections to reflect these postmarketing reports. FDA […]
FDA Accepts VCTE Liver Stiffness as a “Reasonably Likely” Surrogate Endpoint in MASH: What Changed, Why It Matters, and What Happens Next
Date of FDA statement: August 27–28, 2025Scope: Adults with non-cirrhotic MASH and moderate-to-advanced fibrosis (trial context) TL;DR The FDA’s Office of New Drugs accepted a Letter of Intent (LOI) to qualify Liver Stiffness Measurement (LSM) by vibration-controlled transient elastography (VCTE)—e.g., FibroScan—as a reasonably likely surrogate endpoint (RLSE) for MASH trials. The proposed endpoint aims to […]
FDA Removes REMS Program for Clozapine: Insight, Rationale & Implications
1. What’s New? Effective June 13, 2025, the FDA officially eliminated the Clozapine REMS (Risk Evaluation and Mitigation Strategy) program for clozapine (e.g. Clozaril, Versacloz, generics) GovDeliverynewclozapinerems.com.In practice, as of February 24, 2025, the FDA no longer expects prescribers, pharmacies, or patients to enroll in REMS or report ANC results before dispensing clozapine U.S. Food […]
FDA Recommends Earlier MRI Monitoring for Leqembi (lecanemab): What Changed, Why It Matters, and the Real-World Impact
Date of FDA communication: August 28, 2025 Summary (TL;DR) The FDA now recommends an additional, earlier brain MRI before the 3rd Leqembi infusion (previously before the 5th, 7th, and 14th). The shift follows an analysis of serious ARIA-E cases and six early-treatment fatalities, suggesting earlier imaging may detect brain swelling sooner and help clinicians pause […]
FDA Presses Nicotine Pouch Makers to Adopt Child-Resistant Packaging
Background & Key Findings On September 2, 2025, the U.S. Food and Drug Administration (FDA) issued a formal call urging manufacturers of nicotine pouches to implement child-resistant packaging, responding to a dramatic rise in accidental exposures — particularly among very young children U.S. Food and Drug Administration+1. From April 1, 2022 through March 31, 2025, […]
ALERT: Counterfeit Green Lumber Products Contain Undeclared Prescription Drug
Published: August 29, 2025 (FDA) Summary On August 29, 2025, the U.S. Food and Drug Administration published a safety alert based on findings by Green Lumber Holding, LLC, revealing that counterfeit products marketed under the Green Lumber dietary-supplement brand were adulterated with tadalafil, a prescription-only medication used for erectile dysfunction—an ingredient never used in authentic […]