Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system

Chen, Jiaojiao; Huo, Xue-Chen; Wang, Shaoxia; Wang, Fei; Zhao, Quan

doi:10.1007/s11096-022-01472-x

Cited by 15 publications

(3 citation statements)

References 45 publications

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“…Adopt the ROR and MHRA method, the ROR, proportional reporting ratio (PRR), and X 2 equivalents are calculated, respectively. To avoid false-positive signals, the calculated corresponding values should reach the set threshold and be defined as the PT of valid signals (See Supplementary Table S2 ) ( 18–20 ). The larger the calculated value, the stronger the signal, indicating that the target drug is more likely to be associated with the target AEs, but this does not mean that there is a causal relationship between the two ( 21 ).…”

Section: Methodsmentioning

confidence: 99%

Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system

Shi,

He,

Dan

et al. 2024

Front. Med.

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BackgroundVarious immune checkpoint inhibitors, such as programmed cell death protein-1 (PD-1) and its ligand (PD-L1), have been approved for use, but they have side effects on the endocrine glands.MethodsAdverse event reports related to PD-1/PD-L1 inhibitors from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2019 to the first quarter of 2023 were extracted, and the reported Odds ratio methods (ROR method) and comprehensive standard methods (MHRA methods) were used for data mining and analysis.ResultsA total of 5,322 reports (accounts for 6.68% of the total reports)of AEs in endocrine system were collected, including 1852 of pabolizumab (34.80%), 2,326 of navuliumab (43.71%), 54 of cimipriliumab (1.01%), 800 of atilizumab (15.03%), 222 of duvariumab (4.17%) and 68 of averumab (1.28%). Endocrine system-related AEs were mainly present in men (excluding those treated with pembrolizumab) aged ≥65 years. The ratio of AEs components in the endocrine system for the six drugs was approximately 3–8%. The main endocrine glands involved in AEs were the thyroid (pembrolizumab), pituitary and adrenal (nivolumab), adrenal (cemiplimab, atezolizumab, and avelumab), and thyroid (durvalumab). Most patients experienced AEs between 30 and 365 (mean, 117) days,the median time was 61d. AEs resulted in prolonged hospitalization in >40% and death in >10% of cases after administration of pembrolizumab, nivolumab, or durvalumab.ConclusionMen aged ≥65 years should be concerned about endocrine-related AEs. There was a lengthy interval between the use of PD-1/PD-L1 inhibitors and endocrine system-related AEs, but the outcome was serious. Special attention should be given to endocrine system-related AEs when using pembrolizumab, nivolumab, or durvalumab.

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Section: Methodsmentioning

confidence: 99%

Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system

Shi,

He,

Dan

et al. 2024

Front. Med.

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“…For PRR, a positive signal was defined by PRR≥3, chi-square value ≥ 5, and ≥5 cases. For ROR, positive signals were identified with the low boundary of 95% CI > 2 and at least 5 cases submitted ( Chen et al, 2022 ).…”

Section: Methodsmentioning

confidence: 99%

Drug-induced tooth discoloration: An analysis of the US food and drug administration adverse event reporting system

Wang

Zou

et al. 2023

Front. Pharmacol.

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Background: Certain drugs can cause intrinsic or extrinsic tooth discoloration, which is not only a clinical issue but also an esthetic problem. However, limited investigations have focused on drug-induced tooth discoloration. The present work aimed to determine the drugs causing tooth discoloration and to estimate their risks of causing tooth discoloration.Methods: An observational, retrospective, and pharmacovigilance analysis was conducted, in which we extracted adverse event (AE) reports involving tooth discoloration by using the data of the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021. Disproportionality analyses were performed to examine risk signals for tooth discoloration and determine the drugs inducing tooth discoloration.Results: Based on predefined inclusion criteria, 1188 AE reports involving 302 suspected drugs were identified. After data mining, 25 drugs generated positive risk signals for tooth discoloration, of which 10 were anti-infectives for systemic use. The top reported drug was tetracycline (n = 106), followed by salmeterol and fluticasone (n = 68), amoxicillin (n = 60), chlorhexidine (n = 54), and nicotine (n = 52). Cetylpyridinium (PRR = 472.2, ROR = 502.5), tetracycline (PRR = 220.4, ROR = 277), stannous fluoride (PRR = 254.3, ROR = 262.8), hydrogen peroxide (PRR = 240.0, ROR = 247.6), and chlorhexidine (PRR = 107.0, ROR = 108.4) showed stronger associations with tooth discoloration than the remaining drugs. Of 625 AE reports involving 25 drugs with positive risk signals, tooth discoloration was mostly reported in patients aged 45–64 (n = 110) and ≤18 (n = 95), and 29.4% (192/652) of the reports recorded serious outcomes.Conclusion: This study revealed that certain drugs are significantly associated with tooth discoloration. Caution should be exercised when using these drugs, especially during pregnancy and early childhood.

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“…The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved daptomycin for treatment in complex skin and soft tissue infections, as well as aureus bacteremia with complex skin and soft tissue infections or right-sided infective endocarditis. The most commonly reported adverse effects of daptomycin were myopathy and eosinophilic pneumonia [14]. However, daptomycin-induced myopathy has been described in about 2-14% of patients receiving daptomycin [15], and rhabdomyolysis was as high as 5% [16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

Reporting of Drug-Induced Myopathies Associated with the Combination of Statins and Daptomycin: A Disproportionality Analysis Using the US Food and Drug Administration Adverse Event Reporting System

Wei

Yin

et al. 2023

JCM

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Background: Myopathy is one of the most common adverse reactions of daptomycin and statins. We aimed to evaluate the muscular toxicity of the combination therapy of daptomycin and statins in a large pharmacovigilance database. Methods: This was a retrospective disproportionality analysis based on real-world data. All cases reported between the first quarter of 2004 and the fourth quarter of 2022 where daptomycin and statins were reported were gathered from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analyses were conducted by estimating the proportional reporting ratios (PRRs), reporting odds ratio (ROR), and information component (IC). Results: A total of 971,861 eligible cases were collected from the FAERS database. Data analysis showed that rosuvastatin (ROR: 124.39, 95% CI: 87.35–178.47), atorvastatin (ROR: 68.53, 95% CI: 51.93–90.43), and simvastatin (ROR: 94.83, 95% CI: 71.12–126.46) combined with daptomycin increased the reporting frequency of myopathy. Moreover, myopathy was reported more frequently with the 3-drug combination (ROR: 598.01, 95% CI: 231.81–1542.71). For rhabdomyolysis, the frequency of reports also increased when daptomycin was combined with rosuvastatin (ROR: 156.34, 95% CI: 96.21–254.05), simvastatin (ROR: 72.65, 95% CI: 47.36–111.44), and atorvastatin (ROR: 66.31, 95% CI: 44.06–99.81). Conclusions: The combination of daptomycin and statins increased the association of myopathy and rhabdomyolysis, especially with rosuvastatin, simvastatin, and atorvastatin.

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Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system

Cited by 15 publications

References 45 publications

Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system

Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system

Drug-induced tooth discoloration: An analysis of the US food and drug administration adverse event reporting system

Reporting of Drug-Induced Myopathies Associated with the Combination of Statins and Daptomycin: A Disproportionality Analysis Using the US Food and Drug Administration Adverse Event Reporting System

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