2025 IgNS Clinical Abstract

Pharmacovigilance and Safety Signals: A Data Review of Adverse Events Linked to Withdrawn Immunoglobulin Lots

Authors: Christine Miller, PharmD; Zak Stratton, PharmD, CSP, IgCP; Lisa Siefert, RPh, FASHP, ASQ-CMQ/OE; Derrek Blake, RN, BSN, IgCN – Soleo Health

Introduction

In early 2025, four immunoglobulin (Ig) products across eight different lot numbers were voluntarily withdrawn due to increased reports of hypersensitivity-type reactions. Adverse event (AE) reporting plays a critical role in identifying widespread safety signals, yet reporting systems and practices can vary widely across healthcare settings. This study aims to evaluate the AE reporting experience of a national specialty pharmacy related to these Ig product withdrawals.

Results

• A total of 64 AEs were reported for patients receiving any Ig product during the 3-month period
• Twenty-six AEs were reported across five of the eight withdrawn lots of Ig products
• Twenty of the 26 (77%) AE reports were documented prior to the official withdrawal notification for the affected lot numbers
• The reactions varied across different severities: 27% mild (Grade 1), 42% moderate (Grade 2), and 19% severe (Grade 3)
• Grade 3 reactions required urgent intervention and escalation to the corporate clinical department
• MedWatch forms were completed for 12 (46%) of the 26 AEs
• Direct communication with the manufacturer occurred for all 26 AEs related to the impacted lots

Definitions

AE: Adverse event

Grade 1 AE: Minor; asymptomatic/mild symptoms; no intervention

Grade 2 AE: Moderate; intervention required

Grade 3 AE: Severe; urgent intervention; emergency department, urgent care, or hospitalization

Discussion

This analysis advocates the reinforcement and ongoing review of pharmacovigilance practices through clear AE response protocols, defined roles, escalation pathways, and criteria for MedWatch submission versus direct manufacturer notification.

Specialized Ig programs with dedicated clinical staff and tailored patient assessments enabled early detection of safety signals and trend analysis. Reactions identified in long-term patients that had previously been stable on Ig therapy led to heightened awareness throughout the organization, and AE documentation and escalation procedures were readdressed with the clinical staff.

For patients reporting reactions, concurrent medications, rate of administration, pre-medications, if any, and overall patient clinical history were reviewed. Collaboration among local clinicians, nurses performing Ig administration, pharmacist engagement in review of AEs, and organizational review of pharmacovigilance data aided early identification of AE trends by product type and lot number.

Annual training and procedure reviews are recommended to reinforce compliance and responsiveness. Priority activities included coordinating patient outreach, prescriber communication, and, where applicable, replacement of affected products.

The withdrawals’ timing at the beginning of the calendar year coincided with benefit reverification periods and may have contributed to underreporting, emphasizing the need for streamlined reporting processes during high-demand periods.

Clarifying expectations for voluntary MedWatch submissions is also essential, as these may require documentation beyond internal systems.