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 Safety Labeling Change: CORTISPORIN® Ointment — What Changed, What to Update, and How Shudarsana Can Help
What changed (SrLC highlight) On Aug 8, 2025 (SUPPL-86) the FDA approved an update to Adverse Reactions adding the statement: “Skin hyperpigmentation has been reported with polymyxin B containing products.” FDA Access Data+1 This is now explicitly listed alongside other topical corticosteroid/antibiotic local reactions and informs clinicians and patients about a pigmentary risk previously not […]
FDA Safety Labeling Changes for ACTEMRA (tocilizumab): What Changed, PV & Regulatory Impact, and a Playbook for Shudarsana
What changed in the U.S. label Newest update (August 8, 2025): Recent prior update (September 2024): Practical takeaway: Two concurrent risk domains now shape operations—expanded pediatric COVID-19 use (dosing, handling, benefit–risk) and heightened vigilance for severe hypersensitivity/SCARs. FDA Access Data+1 What needs to change internally (manufacturer/MAH “to-do” list) Pharmacovigilance impact Signal detection & case processing […]
Recent Safety Labeling Changes for BYOOVIZ
On August 15, 2025, the FDA approved safety-related labeling changes for BYOOVIZ (ranibizumab-nuna, BLA-761202) FDA Access Data. Key updates include: Impact on Pharmacovigilance Processes 1. Enhanced Signal Detection and Monitoring 2. Case Processing & Reporting 3. Update of Safety Documents 4. Risk Communication Impact on Regulatory Strategy 1. Labeling and Submission Updates 2. Compliance with […]
FDA Requires New Class Warning for mRNA COVID-19 Vaccines: Myocarditis/Pericarditis Update (June 2025)
Meta title (≤60 chars): FDA adds myocarditis warning to mRNA COVID-19 shotsMeta description (≤155 chars): FDA now requires updated warnings on Pfizer and Moderna mRNA COVID-19 vaccines, with new incidence estimates and post-marketing findings. TL;DR What exactly did FDA do? The new label language—what’s different? Why the update now? FDA determined new safety information met […]
FDA lifts pause on IXCHIQ for adults ≥60 and approves new label warnings
What happened—quick timeline Why the concern in the first place? IXCHIQ is a live, attenuated chikungunya vaccine; it can produce chikungunya-like symptoms. FDA’s case review included serious adverse events in older adults, some consistent with severe complications of chikungunya disease (e.g., encephalitis). One death from encephalitis was specifically noted in FDA’s safety communication, and earlier […]
FDA Adds Heat-Risk Warning to Transderm Scōp (Scopolamine Patch): What Patients, Clinicians, and Manufacturers Need to Know
What happened (and when)? On June 18, 2025, the U.S. FDA issued a Drug Safety Communication requiring new warnings for the anti-nausea patch Transderm Scōp. The agency concluded the patch can increase body temperature and lead to heat-related complications, with reports that include hospitalizations and, in some cases, death. Most reported cases occurred in children […]
FDA Mandates New Warnings on Extended-Release ADHD Stimulants
What’s Changing? On June 30, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication requiring all manufacturers of extended-release (ER) stimulants—including both amphetamine and methylphenidate formulations—used for attention-deficit/hyperactivity disorder (ADHD) to revise their prescribing information (PI). The update mandates inclusion of a “Limitation of Use” section highlighting that children under 6 years […]
FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication
Breaking Down the FDA’s Latest Mandate on Opioid Labeling What’s Going On? On July 31, 2025, the FDA released a class-wide Drug Safety Communication mandating that all opioid pain medicine manufacturers update prescribing information to better reflect the risks of long-term use U.S. Food and Drug AdministrationHHS.gov. This follows observational data from two post-marketing studies—PMR […]