Haining Huang

and 7 more

Aims: Our study aimed to assess the risk signals of antibiotic-associated diarrhea (AAD) caused by various antibiotics using real-world data and provide references for safe clinical applications. Methods: We analyzed data extracted from the FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter of 2004 to the third quarter of 2022. We computed the odds ratio (ROR) for each antibiotic or antibiotic class to compare the signal difference. Furthermore, we also examined the differences in the onset times and outcomes of AAD caused by various antibiotics. Results: A total of 5,397 reports met the inclusion requirements. Almost all antibiotics, except tobramycin and minocycline (ROR 0.98 and 0.42, respectively), showed a significant correlation with AAD. The analysis of the correlation between different classes of antibiotics and AAD revealed that lincomycins (ROR 29.19), third-generation cephalosporins (ROR 15.96), and first/second generation cephalosporins (ROR 15.29) ranked the top three. The ROR values for antibiotics from the same class of antibiotics also varied greatly, with the ROR values for third-generation cephalosporins ranging from 9.97 to 58.59. There were also differences in ROR values between β-lactamase inhibitors and their corresponding β-lactamase drugs, such as amoxicillin-clavulanate (ROR = 13.31) and amoxicillin (ROR = 6.50). 91.35% antibiotics have an onset time of less than four weeks. Conclusions: There is a significant correlation between almost all antibiotics and AAD, particularly lincomycins and β-lactam antibiotics, as well as a different correlation within the same class. These findings offer valuable evidence for selecting antibiotics appropriately.

JING PENG

and 6 more

Objective To explore the risk signals of osteonecrosis of jaw induced by antiresorptive drugs and provide references for the clinical safety application. Method Based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to June 2021, We chosen ‘Osteonecrosis of jaw’ as Preferred Terms (PT) and antiresorptive drugs. We used proportional reporting ratio (PRR), odds ratio (reporting odds ratio, ROR), Bayesian confidence propagation neural network (BCPNN) and multi-item Gamma-Poisson contraction (MGPS) algorithm to evaluate the association between drugs and adverse events. Results 27,065 reports related to osteonecrosis of the jaw in the FAERS dated from January 2004 to June 2021 . A total of 9 antiresorptive agents were included in the analysis. Affected patients tended to be older than 65 years. Most cases were reported from North America (39.82%) and Europe (36.15%) and were submitted by health-care professionals (81.44%). Pamidronate and clodronic acid showed a higher score than the other agents in every method. Zoledronic acid and denosumab were reported more than other agents.. Rate of hospitalization due to antiresorptive-related osteonecrosis of the jaw was from 7.66% to 28.78%; rate of fatality was from 0 to 12.78%. Conclusion All antiresorptive drugs may cause ONJ, and ONJ can be effectively prevented. Practitioners should consider the factors that may increase the likelihood of ONJ. The findings support a continued surveillance and risk factor identification studies.