What question did this study set out to answer?

To characterize the safety profile of 23 monoclonal antibodies with FDA black box warnings using pharmacovigilance data.

Postmarketing Safety Concerns With FDA Black Box Warning Monoclonal Antibodies: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System Database

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Pharmacovigilance study investigates safety signals of monoclonal antibodies with black box warnings, indicating ongoing safety concerns.

To characterize the safety profile of 23 monoclonal antibodies with FDA black box warnings using pharmacovigilance data.
Analyzed 330,851 FAERS reports from Q1 2021 to Q2 2025 for adverse events related to 23 mAbs.
Applied disproportionality analysis, including PRR and ROR, to identify safety signals.
Tracked temporal patterns in adverse event reporting quarterly across the study period.
Ipilimumab exhibited the strongest signal for immune-mediated dermatitis (PRR 232.12; ROR 250.41).
Panitumumab showed high Bayesian certainty for skin toxicity (IC₀₂₅ 4.61).
Immune-related adverse events for checkpoint inhibitors increased in signal intensity over time.

Kalaivani et al. (2026) studied this question.

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View Full Paper

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Authors

Pharmacovigilance study investigates safety signals of monoclonal antibodies with black box warnings, indicating ongoing safety concerns.

To characterize the safety profile of 23 monoclonal antibodies with FDA black box warnings using pharmacovigilance data.
Analyzed 330,851 FAERS reports from Q1 2021 to Q2 2025 for adverse events related to 23 mAbs.
Applied disproportionality analysis, including PRR and ROR, to identify safety signals.
Tracked temporal patterns in adverse event reporting quarterly across the study period.
Ipilimumab exhibited the strongest signal for immune-mediated dermatitis (PRR 232.12; ROR 250.41).
Panitumumab showed high Bayesian certainty for skin toxicity (IC₀₂₅ 4.61).
Immune-related adverse events for checkpoint inhibitors increased in signal intensity over time.

Kalaivani et al. (2026) studied this question.

View Full Paper

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