Expert Opinion on Drug Safety

BACKGROUND: Several patient characteristics may be of influence on treatment pathways of rheumatoid arthritis (RA) patients in clinical practice. The aim of this study is to analyze treatment pathways of early RA patients stratified for gender and adverse drug reaction (ADR) occurrence. RESEARCH DESIGN AND METHODS: Treatment pathways of patients included in the DREAM-RA treat-to-target cohort I between 16th of July 2006-30th of April 2020 were assessed. Treatment pathways were visualized in Sankey diagrams...

OBJECTIVES: To evaluate Hy's law, DrILTox ALF Score, Robles-Diaz Model and a new logistic regression model for predicting acute liver failure (ALF) in Chinese patients with drug-induced liver injury (DILI). METHODS: we conducted a retrospective study among 514 hospitalized DILI patients from 2011 to 2020. Logistic regression analysis was used to develop a predictive model for ALF. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of these models were compared...

BACKGROUND: In patients with type 1 diabetes mellitus (T1D), sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with an increased risk of diabetic ketoacidosis (DKA). Ipragliflozin is an SGLT2 inhibitor approved in Japan in combination with insulin for patients with T1D. RESEARCH DESIGN AND METHODS: Spontaneous safety reports of ipragliflozin adverse drug reactions (ADRs) in patients with T1D were collected during early post-marketing phase vigilance (EPPV; 21 December 2018-20 June 2019)...

BACKGROUND: Few studies have compared the safety risks between the gabapentinoids, pregabalin, and mirogabalin in post-marketing clinical settings. We assessed reported events associated with gabapentinoid use in patients with neuropathic pain. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study between September 2020 and December 2020 using the community pharmacies records in Japan. The pharmacists identified new vs. prevalent users of mirogabalin and pregabalin in September 2020 and reported data regarding baseline and adverse events to the Japan Pharmaceutical Association using web-based questionnaires...

OBJECTIVES: Taxane-related neurotoxicity is a frequent clinical problem but lacks postmarketing data regarding neurological disorders. This study aimed to evaluate the potential association between neurological adverse events and several taxane-derived drugs via the Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Disproportionality analysis was applied to data mining of the suspected cases of neurological disorders after using different taxanes based on the FAERS data from January 2017 and December 2021...

BACKGROUND: China has the highest proportion of lung cancer-related deaths. Drug therapy is the main tool of comprehensive anticancer treatment. However, most studies to date have focused on certain types of targets or immunotherapeutic modalities for drug safety; few studies have addressed the factors that influence ADRs for each type of drug in patients with lung cancer, and even fewer studies have explored the risk factors for certain types of ADRs. Based on it, we comprehensively evaluate the drug safety of patients and provide a clinical reference with a focus on lung cancer...

BACKGROUND: BRAF and MEK inhibitor combination therapy have significantly improved the outcome of several BRAF-mutation tumors, but it also confers the risk of drug-induced ocular adverse events (oAEs). However, very few studies focused on this risk. METHODS: The United States Food and Drug Administration Adverse Event Reporting System (FAERS) data from Quarter 1-2011 to Quarter 2-2022 were searched to detect signs of oAEs of three marketed BRAF and MEK inhibitor combination therapies: vemurafenib plus cobimetinib (V + C), dabrafenib plus trametinib (D + T), and encorafenib plus binimetinib (E + B)...

BACKGROUND: : Various Adverse Drug Reactions (ADRs) are associated with Proton Pump Inhibitors (PPIs). However, the effects of PPIs on renal system are unclear so far. Thus, the main objective of the current study was to identify possible signals of PPIs in the renal system. MATERIALS AND METHODS: Data Mining Algorithms (DMAs) such as Proportional Reporting Ratio i.e., PRR (≥2) with associated Chi-square value (>4), Reporting Odds ratio i.e., ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal...

INTRODUCTION: This paper encompasses a summary of the safety and cardiometabolic efficacy of novel antidiabetic drugs. There are three major drug classes discussed in this review: dipeptidyl dipeptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAS) and sodium-glucose cotransporter-2 (SGLT2) inhibitors. A literature review of the landmark cardiovascular outcomes trials from 2008 to 2021 was conducted on Pubmed.gov. Based on 2008 guidance from the US Food and Drug Administration, a non-inferiority margin of 1...

BACKGROUND: Anticoagulant and antiaggregant drugs are drug groups with high mortality and the most common cause of malpractice. RESEARCH DESIGN AND METHODS: 18 and 65 years were scheduled for pharmacotherapy in the Family Health Center. 122 patients during their anticoagulant and/or antiaggregant treatment were evaluated in terms of drug-drug interactions. RESULTS: Drug-drug interactions were detected in 89.7% of the patients included in the study...

INTRODUCTION: Respiratory depression and opioid-related death are reported when opioids are associated with gabapentinoids. Meta-analyses of randomized clinical trials investigating efficacy and safety of such association failed to assess these risks because of the lack of data. The aim of this systematic review was to investigate the risk of respiratory depression or death during this combination in the scientific literature, including case reports or series, observational studies, and clinical trials...

BACKGROUND: Several therapies directed at novel targets and also immunotherapies have recently shown promising results in advanced or metastatic TNBC. We aimed to compare the efficacy and safety of these new regimens for advanced or metastatic TNBC (mTNBC). METHODS: The PubMed, Embase, and Cochrane Library electronic databases were searched for phase III randomized trials. We conducted a network meta-analysis to compare the efficacy and safety of new targeted and immunotherapy regimens...

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BACKGROUND: Romiplostim and eltrombopag are thrombopoietin receptor agonists (TPORAs) that have been approved by the FDA on 22 August 2008 and 20 November 2008 for pediatric immune thrombocytopenia (ITP). However, postmarketing pharmacovigilance of TPORAs in children still attracts much attention. We aimed to evaluate the safety of the TPORAs romiplostim and eltrombopag using data from the Adverse Event Reporting System database of FDA (FAERS). RESEARCH DESIGN AND METHODS: We conducted a disproportionality analysis and analyzed data from the FAERS database to characterize the key features of adverse events (AEs) associated with TPO-RAs approved for children under 18 years of age...

BACKGROUND: Thrombosis is the second leading cause of mortality in cancer patients. This study aimed to investigate the association between cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) and thrombosis. RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance analysis based on real-world data combined with a systematic review was used to explore the thrombotic risk profiles of CDK4/6i. The study has been registered with Prospero (CRD42021284218). RESULT: In the pharmacovigilance analysis, CDK4/6i showed a higher rate of reported venous thromboembolism (VTE) (ROR = 2...

BACKGROUND: Budesonide-MMX is a topically active corticosteroid degraded by cytochrome-P450 enzymes, resulting in favourable side-effect profile. We aimed to assess effect of CYP genotypes on safety and efficacy, and make a direct comparison with systemic corticosteroids. RESEARCH DESIGN AND METHODS: We enrolled UC patients receiving budesonide-MMX and IBD patients on methylprednisolone in our prospective, observational-cohort study. Before and after treatment regimen clinical activity indexes, laboratory parameters (electrolytes, CRP, cholesterol, triglyceride, dehydroepiandrosterone, cortisol, beta-crosslaps, osteocalcin), and body composition measurements were assessed...

BACKGROUND: Commonly prescribed antidepressants (paroxetine, fluoxetine, duloxetine, bupropion) inhibit bioconversion of several prodrug opioid medications to their active metabolite, potentially decreasing analgesic effect. There is a paucity of studies assessing the risk-benefit of concomitant administration of antidepressants and opioids. RESEARCH DESIGN AND METHODS: Observational study of adult patients taking antidepressants prior to scheduled surgery using 2017-2019 electronic medical record data to assess perioperative use of opioids and to determine the incidence and risk factors for developing postoperative delirium...

BACKGROUND: At present, there is no predictive model that can predict the prevalence of potentially inappropriate medication (PIM) use in older lung cancer outpatients. RESEARCH DESIGN AND METHODS: We measured PIM by the 2019 Beers criteria. Significant factors were identified to develop the nomogram using logistic regression. We validated the nomogram internally and externally in two cohorts. The discrimination, calibration, and clinical practicability of the nomogram were verified using receiver operating characteristic (ROC) curve analysis, Hosmer-Lemeshow test, and decision curve analysis (DCA), respectively...

BACKGROUND: Anaplastic lymphoma kinases (ALK) tyrosine kinase inhibitors (TKIs) are targeted therapies used in advanced ALK-positive non-small cell lung cancers (NSCLC) which showed excellent efficacy and safety. However, ALK TKIs-associated cardiovascular toxicities [cardiac disorders, venous thromboembolic events (VTEs), and hypertension] have been raising more attention and remain incompletely characterized. We conducted the first meta-analysis to investigate the cardiovascular toxicities associated with ALK TKIs in patients with ALK-positive NSCLC...

BACKGROUND: Many signal detection algorithms give the same weight to information from all products and patients, which may result in signals being masked or false positives being flagged as potential signals. Subgrouped analysis can be used to help correct for this. RESEARCH DESIGN AND METHODS: The publicly available US Food and Drug Administration Adverse Event Reporting System quarterly data extract files from January 1, 2015 through September 30, 2017 were utilized...