Antiviral influenza treatments and hemorrhage-related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

STUDY OBJECTIVE: To determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. DESIGN: Disproportionality analysis. DATA SOURCE: The FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022. MEASUREMENTS: Antiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications. MAIN RESULTS: A total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage. CONCLUSION: In this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.

Scrutiny of 13C-phenylalanine breath test reproducibility.

We evaluated the reproducibility of the 13C-phenylalanine breath test (13C-PheBT). On three separate days, 21 healthy volunteers (11 F and 10 M) underwent 13C-PheBT with 100 mg l-[1-13C]phenylalanine taken orally. Short-term reproducibility was evaluated with paired examinations taken 3 days apart; paired examinations separated by 23 days (median) served for the medium-term reproducibility assessment. Expiratory air was sampled at 19 points throughout 3 h. Determined limited reproducibility of the 13C-PheBT must be taken into consideration while interpreting the results of this diagnostic tool. The results of this study imply the following conclusions: (i) From among the three parameters examined, the cumulative 13C recovery area under the curve (AUC) offers much better reproducibility than the maximum momentary 13C recovery in the expiratory air (Dmax) or the time to reach the maximum momentary 13C recovery (Tmax) (ii) Collection of the breath air samples for 2 h results in a much better reproducibility of AUC, than for 1 h only; (iii) Reproducibility of 13C-PheBT is affected neither by the duration of the time gap between repeated tests nor by gender; (iv) Comparison with data obtained formerly reveals that reproducibility of the 13C-PheBT is worse than either that of of the 13C-methacetin (13C-MBT) or the 13C-alpha-ketoisocaproic acic (13C-KICA-BT) breath tests. This finding will have to be taken into consideration while interpreting the results of this diagnostic tool.