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

Wang, Jun; Zou, Dongna; Li, Yuchao; Li, Pingping; Guo, Chang-Jun

doi:10.3389/fphar.2023.1161728

Cited by 10 publications

(4 citation statements)

References 44 publications

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“…Unfortunately, regarding pharmacological interventions, not only are there a relatively limited number of drugs for oral mucositis, but the efficacy of these drugs is not satisfactory (Blanchard et al, 2022;Bockel et al, 2018), and the side effects and high prices also hinder their utilisation (Kobya Bulut & Güdücü Tüfekci, 2016). For instance, the alcohol component of benzylamine may cause burning in the mouth (Putwatana et al, 2009), long-term prescription of glucocorticoid medications and chlorhexidine mouthwash can lead to a high risk of oral fungal infections and tooth discolouration, respectively (Nishii et al, 2020;Wang et al, 2023), and Keratinocyte Growth Factor-1 is overpriced, at up to $1200 for a single vial (Kobya Bulut & Güdücü Tüfekci, 2016).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of nonpharmacological interventions for severe radiation‐induced oral mucositis among head and neck cancer patients: A network meta‐analysis of randomised controlled trials

Zhang,

Li,

Zhang

et al. 2024

Journal of Clinical Nursing

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Aims and ObjectivesTo assess the effectiveness of different nonpharmacological treatments for severe radiation‐induced oral mucositis in patients with head and neck cancer.BackgroundRadiation‐induced oral mucositis is highly prevalent in patients with head and neck cancer. Current medications for radiation‐induced oral mucositis are limited in effectiveness and susceptible to side effects, and while there is an increasing adoption of nonpharmacological interventions, the optimal one remains unclear.DesignSystematic review and network meta‐analysis based on the PRISMA‐NMA guidelines.MethodsSix databases were searched. Two authors independently performed the literature screening, data extraction and methodological quality assessment of the included studies. Traditional pairwise meta‐analysis was performed by R Studio. A network meta‐analysis was then conducted to assess the effects of nonpharmacological interventions for severe radiation‐induced oral mucositis in patients with head and neck cancer.ResultsFifty‐two studies involving seven types of nonpharmacological interventions were enrolled. The network meta‐analysis indicated that natural plant‐based therapies might be the most effective, health education interventions might be the second most effective, and honey might be the third most effective interventions for reducing the incidence of severe radiation‐induced oral mucositis. For reducing the incidence of severe oral mucositis‐related pain, the pairwise meta‐analysis showed that only natural plant‐based therapies and health education interventions were effective.ConclusionsNonpharmacological interventions are effective in the management of severe radiation‐induced oral mucositis among patients with head and neck cancer.Relevance to clinical practiceNonpharmacological interventions are a category of safe and effective adjunctive therapies that should be encouraged in clinical practice.Trial registration detailsCRD42023400745.

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Section: Introductionmentioning

confidence: 99%

Efficacy of nonpharmacological interventions for severe radiation‐induced oral mucositis among head and neck cancer patients: A network meta‐analysis of randomised controlled trials

Zhang,

Li,

Zhang

et al. 2024

Journal of Clinical Nursing

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“…It provides a vast source of real-world data for the early identification of AEs ( Zhao et al, 2023 ). AE information in the FAERS database is documented and analyzed individually, making the data more basic ( Wang J. et al, 2023 ). By mining AE signals in FAERS, unrecognized safety signals can be managed during clinical development for risk management purposes ( Wang F. et al, 2023 ).…”

Section: Introductionmentioning

confidence: 99%

Assessing the safety of bedaquiline: insight from adverse event reporting system analysis

Wu,

Pan,

Shen

et al. 2024

Front. Pharmacol.

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BackgroundThe development and marketing of Bedaquiline (BDQ) represent significant advancements in treating tuberculosis, particularly multidrug-resistant forms. However, comprehensive research into BDQ’s real-world safety remains limited.PurposeWe obtained BDQ related adverse event (AE) information from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) to assess its safety and inform drug usage.MethodsThe AE data for BDQ from 2012 Q4 to 2023 Q3 was collected and standardized. Disproportionality analysis, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN) was used to quantify signals of BDQ-related AEs. Logistic regression was used to analyze the individual data of hepatotoxicity and drug-induced liver injury, and multiple linear regression models were established. Additionally, network pharmacology was employed to identify the potential biological mechanisms of BDQ-induced liver injury.ResultsWe identified 2017 case reports directly related to BDQ. Our analysis identified 341 Preferred Terms (PTs) characterizing these AEs across 27 System Organ Classes (SOC). An important discovery was the identification of AEs associated with ear and labyrinth disorders, which had not been documented in the drug’s official leaflet before. Subgroup analysis revealed a negative correlation between BDQ-related liver injury and females (OR: 0.4, 95%CI: 0.3–0.6). In addition, via network pharmacology approach, a total of 76 potential targets for BDQ related liver injury were predicted, and 11 core target genes were selected based on the characterization of protein-protein interactions. The pathway linked to BDQ-induced liver injury was identified, and it was determined that the PI3K-Akt signaling pathway contained the highest number of associated genes.ConclusionThe analysis of the FAERS database revealed adverse events linked to BDQ, prompting the use of a network pharmacology approach to study the potential molecular mechanism of BDQ-induced liver injury. These findings emphasized the significance of drug safety and offered understanding into the mechanisms behind BDQ-induced liver injury. BDQ demonstrated distinct advantages, including reduced incidence of certain adverse events compared to traditional treatments such as injectable agents and second-line drugs. However, it is important to acknowledge the limitations of this analysis, including potential underreporting and confounding factors. This study provides valuable insights into the safety of BDQ and its role in the management of MDR-TB, emphasizing the need for continued surveillance and monitoring to ensure its safe and effective use.

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“…In some subjects, such as children, antibiotics can interfere with tissue development and cause significant adverse events. The damage caused to both the cartilage in weight-bearing joints and the epiphyseal cartilage following the administration of fluoroquinolones [ 15 ], as well as the discoloration of permanent teeth following old tetracycline administration [ 16 ], are due to the increased sensitivity of the developing tissues to the antibiotic stimuli. These adverse events should be known, and the use of these drugs in at-risk subjects should be avoided whenever possible.…”

Section: Introductionmentioning

confidence: 99%

Genetic Variations and Antibiotic-Related Adverse Events

Principi,

Petropulacos,

Esposito

2024

Pharmaceuticals

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Antibiotic-related adverse events are common in both adults and children, and knowledge of the factors that favor the development of antibiotic-related adverse events is essential to limit their occurrence and severity. Genetics can condition the development of antibiotic-related adverse events, and the screening of patients with supposed or demonstrated specific genetic mutations may reduce drug-related adverse events. This narrative review discusses which genetic variations may influence the risk of antibiotic-related adverse events and which conclusions can be applied to clinical practice. An analysis of the literature showed that defined associations between genetic variations and specific adverse events are very few and that, at the moment, none of them have led to the implementation of a systematic screening process for patients that must be treated with a given antibiotic in order to select those at risk of specific adverse events. On the other hand, in most of the cases, more than one variation is implicated in the determination of adverse events, and this can be a limitation in planning a systematic screening. Moreover, presently, the methods used to establish whether a patient carries a “dangerous” genetic mutation require too much time and waiting for the result of the test can be deleterious for those patients urgently requiring therapy. Further studies are needed to definitively confirm which genetic variations are responsible for an increased risk of a well-defined adverse event.

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

Cited by 10 publications

References 44 publications

Efficacy of nonpharmacological interventions for severe radiation‐induced oral mucositis among head and neck cancer patients: A network meta‐analysis of randomised controlled trials

Efficacy of nonpharmacological interventions for severe radiation‐induced oral mucositis among head and neck cancer patients: A network meta‐analysis of randomised controlled trials

Assessing the safety of bedaquiline: insight from adverse event reporting system analysis

Genetic Variations and Antibiotic-Related Adverse Events

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