The FAERS Potential Signals of Serious Risks/New Safety Information listed Beyfortus (nirsevimab-alip) with Hypersensitivity as a potential signal on their October - December 2023 listing.
Analyzing the FAERS data up to 2024 Q1 for reports submitted with this drug as primary suspect drug, the PRR for Hypersensitivity is less than 2 when comparing the drugs within its ATC groups ANTIINFECTIVES FOR SYSTEMIC USE, IMMUNE SERA AND IMMUNOGLOBULINS, IMMUNOGLOBULINS, and ANTIVIRAL MONOCLONAL ANTIBODIES.
NIRSEVIMAB ATCs | PRR | MGPS | BCPNN | ROR | CHISQ |
ANTIINFECTIVES FOR SYSTEMIC USE | 0.42688 | 0.43043 | 43.03003 | 0.4268 | 1.52987 |
IMMUNE SERA AND IMMUNOGLOBULINS | 0.37729 | 0.38114 | 36.66267 | 0.37653 | 2.04936 |
IMMUNOGLOBULINS | 0.38847 | 0.39226 | 36.59209 | 0.3877 | 1.91957 |
ANTIVIRAL MONOCLONAL ANTIBODIES | 0.53425 | 0.53713 | 32.84468 | 0.53172 | 0.81523 |
Hypersensitivity is included in 2 SMQs (Angioedema (SMQ) and Drug reaction with eosinophilia and systemic symptoms syndrome (SMQ)) under the broad scope category, and Hypersensitivity (SMQ) under the narrow scope category. There are no other adverse events reported for NIRSEVIMAB under the HLT Allergic conditions NEC. Hypersensitivity is not included in the EMA IME list. Further analysis is required to confirm the potential signal.
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