Weekly Safety Briefing: March 10–16, 2026

EMA PRAC: new contraindication for adalimumab biosimilars

The Pharmacovigilance Risk Assessment Committee concluded its March signal assessment with a recommendation to add severe hepatic impairment as a contraindication for adalimumab and its biosimilars. The recommendation follows a cumulative review of post-marketing hepatotoxicity reports and a triggered Article 20 referral.

The signal was initially detected through EudraVigilance disproportionality analysis and subsequently confirmed by a detailed case-by-case review of 47 serious hepatotoxicity reports, including 6 cases of acute liver failure. The PRAC concluded that the evidence supported a causal relationship, particularly in patients with pre-existing hepatic compromise.

What this means for practice: Marketing authorization holders will need to update the SmPC and package leaflet. Healthcare professionals should review current patients on adalimumab with known hepatic impairment. The CHMP is expected to adopt the recommendation at its next plenary.

FDA safety communication: GLP-1 receptor agonists

The FDA issued a safety communication updating prescribing information for the GLP-1 receptor agonist class to reflect new post-marketing data on pancreatic safety. The communication covers semaglutide, liraglutide, dulaglutide, and tirzepatide.

The updated labeling incorporates data from the agency's ongoing Sentinel System analysis, which examined pancreatic events across approximately 4.2 million GLP-1 RA-exposed patients. While the overall incidence of acute pancreatitis remained consistent with labeled risks, the analysis identified a previously unreported temporal pattern: risk appears highest in the first 90 days of treatment and attenuates with continued use.

For medullary thyroid carcinoma, the agency noted that ongoing animal carcinogenicity studies for newer agents in the class are providing additional mechanistic data. The boxed warning remains unchanged, but the Warnings and Precautions section now includes updated incidence estimates from post-marketing experience.

What this means for practice: No change to prescribing recommendations. The update refines risk characterization rather than altering the benefit-risk balance. Prescribers should continue monitoring for signs of pancreatitis, particularly in the first three months of treatment.

WHO pharmacovigilance guidance for vaccine programs

The World Health Organization published updated guidance on pharmacovigilance planning for national immunization programs, incorporating lessons learned from the COVID-19 vaccine safety monitoring experience. The document emphasizes three key shifts from the previous 2014 guidance.

First, it recommends that all national programs establish active surveillance capacity — not just passive AEFI reporting — for newly introduced vaccines. The COVID-19 experience demonstrated that spontaneous reporting alone is insufficient to characterize rare adverse events like vaccine-induced immune thrombocytopenia and thrombosis (VITT) in a timeframe that supports regulatory decision-making.

Second, the guidance introduces standardized causality assessment frameworks aligned with the Brighton Collaboration case definitions, replacing the previously recommended WHO algorithm for individual case assessment.

Third, it addresses the communications challenge: how national programs should communicate emerging safety signals transparently while maintaining public confidence — a tension that proved critical during COVID-19 vaccine rollouts.

What this means for practice: National regulatory authorities should review their pharmacovigilance infrastructure against the updated WHO standards. The guidance provides implementation checklists and resource estimation tools for countries at different capacity levels.