A strong reporting signal does not supply the percentage of exposed patients harmed.
The pharmacovigilance analysis identified disproportionate reports involving hypoventilation, cardiovascular events and hypersensitivity. The authors supplemented the reporting analysis with published literature and noted the importance of high-risk clinical settings.
Spontaneous reports lack a reliable denominator of all treated patients. Underreporting, publicity, duplicate information, co-medications and illness severity can influence signals. Disproportionality does not independently prove that the drug caused each event.
Treat a signal as a reason for further investigation rather than a patient-level probability. A forensic account should examine the individual administration, timing, physiology and alternative causes. The database cannot determine whether a specific arrest or allergic presentation would have occurred without the drug.
Source: PMC12373250, supplied full-text paper. Findings are paraphrased; forensic implications are an interpretation.
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