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 Alerts: Severe Itching Risk After Stopping Long-Term Use of Cetirizine or Levocetirizine
What’s the Issue? On May 16, 2025, the FDA issued a Drug Safety Communication warning that discontinuation of cetirizine (Zyrtec) or levocetirizine (Xyzal)—after long-term, daily use—can cause rare but severe and widespread itching (pruritus), sometimes requiring medical attention. This risk applies to both prescription and over-the-counter (OTC) forms. U.S. Food and Drug AdministrationPeople.com How Often […]
Breaking: Amneal Issues Nationwide Recall of Sulfamethoxazole/Trimethoprim Tablets Due to Microbial Contamination
What’s Being Recalled? On June 2, 2025, Amneal Pharmaceutical LLC initiated a nationwide recall of three specific lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination. Tablets from the affected lots may display black spots, identified as Aspergillus, a potentially harmful fungus. This recall only applies to two pack sizes—100-count and 500-count […]
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 […]
Mispackaged Antibiotics: An Investigative Spotlight on Sandoz’s Nationwide Recall
A Critical Mix-Up: What Exactly Happened On June 27, 2025, Sandoz Inc. initiated a voluntary nationwide recall of a single lot of Cefazolin for Injection, USP (1 g vials)—lot number PG4360, with expiration November 2027—after a customer complaint revealed that four vials of Penicillin G Potassium were mistakenly packaged inside a carton intended for Cefazolin […]
DermaRite Recall: How Burkholderia cepacia Contaminated DermaKleen, KleenFoam, DermaSarra & PeriGiene—What You Need to Know
1. Introduction / Hook Start strong with urgency and clarity: On August 8, 2025, DermaRite Industries, LLC issued a voluntary nationwide recall of several OTC hygiene products—including DermaKleen, KleenFoam, DermaSarra, and PeriGiene—due to contamination by the antibiotic-resistant bacterium Burkholderia cepacia, which can cause severe and potentially life-threatening infections. U.S. Food and Drug AdministrationPeople.com 2. What’s […]