Analysis Of Adverse Drug Reactions Research Articles

The Importance of Real-World Data in Evaluating the Safety of Biosimilars: A Descriptive Study of Clinical Practice in an Oncohematological Italian Population.

The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.

Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database.

Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs' Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug's market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.

Retrospective analysis of adverse drug reaction enquiries to a hospital drug information service: lessons to be learned to increase in-hospital drug safety.

Adverse drug reactions (ADRs) are a major drug safety concern and a frequent topic of enquiries to hospital drug information services. Our goal was to analyse these enquiries regarding background, complexity, nature of ADR, and involved drug classes to improve in-hospital drug safety. Retrospectively, ADR enquiries to a German university hospital pharmacy drug information 2018-2022 were analysed regarding enquirer (profession, medical specialty) and enquiry details (drugs, suspected ADR/enquiry prior to drug initiation, ADR system organ class, probable cause identified, and enquiry complexity). Of 543 enquiries, 516 (95%) were asked by physicians, 493 (91%) patient-specific, 390 (71%) on suspected ADRs, and 153 (28%) prior to drug initiation. Enquiries originated frequently from internal medicine (74/13.6%), paediatrics (71/13.1%), neurology (70/12.9%), and haemato-oncology (62/11.4%). Most frequent ADRs were haematologic (94/17%) and hepatic (72/13%). The median number of drugs per enquiry was three (range 0-37), 209 (38%) enquiries referred to one specific drug, 165 (30%) concerned ≥11 drugs. A probable cause for suspected ADRs was identified in 75 (36%) enquiries concerning one drug and 155 (94%) with ≥11 drugs. Most frequent drugs were antineoplastic (54/25.8%), nervous-system-drugs (42/20.1%), and anti-infective (40/19.1%). Most enquiries (342/63%) were complex (multiple/specialist resources). Enquiries were usually asked by physicians referring to suspected ADRs in specific clinical situations. A probable cause was identified in many cases pointing to a direct positive impact on patient care. Enquiries prior to drug initiation should be encouraged to increase drug safety. Information on main ADR effects and drug classes helps with targeted counselling.

Analysis of adverse drug reactions of Denosumab (Prolia) in osteoporosis based on FDA adverse event reporting system (FAERS).

To comprehensively analyze the ADRs associated with Denosumab (Prolia) in the treatment of osteoporosis using data from the FAERS database, and gain a better understanding of the potential risks and side effects of Denosumab (Prolia) therapy. Data of Denosumab (Prolia) were collected from the FAERS database covering the period from first quarter of 2010 to the third quarter of 2023. Disproportionality analysis was performed by calculating the reporting odds ratios (ROR), proportional reporting ratio (PRR), and Bayesian analysis confidence propagation neural network (BCPNN) to detect positive signals. Totally, 17,985,365 reports were collected from the FAERS database, 1,97,807 reports of Denosumab (Prolia) were identified as the "primary suspected (PS)" ADRs. Denosumab (Prolia) induced ADRs occurred in 27 organ systems. 38 significant disproportionality PTs satisfying with the three algorithms were retained at the same time. Unexpected significant ADRs such as bone density abnormal and immobile also occur. The majority of the ADRs occurred within the first 30 days after Denosumab (Prolia) initiation. Based on the American FAERS database, the high frequency ADRs of Denosumab (Prolia) were hypocalcaemia, bone density abnormal, eczema, rebound effect, spinal deformity, etc. Clinical use of this drug should focus on this part of ADRs. Attention should also be paid to newly discovered ADRs, such as immobile, menopausal symptoms, etc., to avoid more serious consequences. Cohort studies, more detailed and comprehensive case information, and long-term clinical investigations are needed to confirm these results and to further understand the safety profile of Denosumab (Prolia).

A RETROSPECTIVE ANALYSIS OF REPORTED CUTANEOUS ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL

Objectives: Analysis of adverse drug reactions (ADR) reports enriches and updates physician’s awareness about the pattern of cutaneous adverse reactions in the population studied and may play an important role to envision the frequency of appearance of reactions to specific drugs and morphological designs. This study intends to portray the clinical profile and causative agents of dermal ADRs in our population. Methods: All the ADR reporting forms received from February 2021 to February 2023 were scrutinized, and forms with cutaneous ADRs (CADRs) were analyzed. The data about the history of drug intake, names of the drug taken, time lag of appearance of reaction, and clinical examination details were collected from the reports. Demography, prevalence, reaction time morphological pattern, and causative agents of CADRs were evaluated. Results: Among the CADRs, acute urticaria 53.4 was the most common followed by acute exanthematous reaction 35.8% and lichenoid drug eruption 3.8%. Among the drugs causing CADRs, antibiotics top the list with 47% followed by ATT at 29.7% and iron sucrose 12.9%. Among the antimicrobials, fluoroquinolones 48% top the list followed by cephalosporins 21.6% and penicillins and vancomycin each 8.3%. Conclusion: Physician’s knowledge about pattern and causative agents of CADR in the specific population can aid in prevention and early management of ADRs and thereby reducing hospitalization.

Retrospective Analysis of Spontaneous Reports of Fatal Adverse Reactions Associated with Lidocaine

SCIENTIFIC RELEVANCE. Pain and pain relief are among the most important problems that arise during medical procedures. Lidocaine is used not only as an anaesthetic during interventions but also as a diluent for other medicinal products. Analysis of adverse drug reactions (ADRs) associated with lidocaine contributes to studying lidocaine toxicity and, as a result, developing measures to reduce side effects.AIM. The authors aimed to conduct a retrospective analysis of spontaneous reports of fatal ADRs associated with lidocaine.MATERIALS AND METHODS. This study analysed spontaneous ADR reports of fatal outcomes associated with lidocaine submitted to the federal ADR database in the Automated Information System of the Federal Service for Surveillance in Healthcare of the Russian Federation (Pharmacovigilance, versions 1.0 and 2.0) from 1 January 2008 to 31 December 2020.RESULTS. The ADR reports included 102 fatal outcomes associated with lidocaine. Most often, lidocaine was prescribed as a local anaesthetic or as a diluent for antibacterials. Studying the administered lidocaine doses, the authors identified several overdose cases. Most life-threatening conditions were due to hypersensitivity reactions of anaphylactic shock (54 cases, 52.9%). Lidocaine administration was accompanied by loss of consciousness, respiratory failure, and cardiac arrest in 10 cases (9.8%). Convulsions were a significant clinical sign in 9 cases (8.8%).CONCLUSIONS. Awareness of the risks of systemic toxic effects of local anaesthetics, including lidocaine, necessitates the practical implementation of certain safety measures, such as allergy skin tests before administration and mandatory monitoring of doses and patients’ well-being after administration.

Comparative Analysis of Adverse Drug Reactions (ADRs) between COVID-19 Vaccines and Established Vaccines: A CDC VAERS Database Analysis

Background: COVID-19 vaccines have been developed rapidly to combat the pandemic, but vaccine hesitancy remains a challenge due to concerns about adverse drug reactions (ADRs). This study aimed to compare the ADR profiles of COVID-19 vaccines with established vaccines and investigate differences between adults and children.
 Methods: A retrospective observational study used the VAERS database to analyze ADR reports from January 2021 to December 2022 in the United States. Top ten common ADRs and seven severe ADRs associated with COVID-19 vaccines were studied using the Evans Criteria.
 Results: Among the common ADRs, only dyspnea showed disproportionate reporting in COVID-19 vaccines. Severe ADRs, including myocarditis, pneumonia, and cerebrovascular accidents, were disproportionately reported. Age-stratified analysis revealed myocarditis disproportionately reported in both adults and children.
 Conclusions: This study provides a comprehensive comparison of ADRs between COVID-19 vaccines and established vaccines. Although some severe ADRs were disproportionately reported, further evaluation is required to establish any causal relationships with COVID-19 vaccine. Continuous monitoring of ADRs is crucial for vaccine safety.

Medication and the Risk of Falls: An Analysis of Adverse Drug Reactions Reported to the Portuguese Pharmacovigilance System

Medication and the Risk of Falls: An Analysis of Adverse Drug Reactions Reported to the Portuguese Pharmacovigilance System

Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study.

Epilepsy is a chronic neurological disease characterized by the presence of spontaneous seizures, with a higher incidence in the pediatric population. Anti-seizure medication (ASM) may produce adverse drug reactions (ADRs) with an elevated frequency and a high severity. Thus, the objective of the present study was to analyze, through intensive pharmacovigilance over 112 months, the ADRs produced by valproic acid (VPA), oxcarbazepine (OXC), phenytoin (PHT), and levetiracetam (LEV), among others, administered to monotherapy or polytherapy for Mexican hospitalized pediatric epilepsy patients. A total of 1034 patients were interviewed; 315 met the inclusion criteria, 211 patients presented ADRs, and 104 did not. A total of 548 ASM-ADRs were identified, and VPA, LEV, and PHT were the main culprit drugs. The most frequent ADRs were drowsiness, irritability, and thrombocytopenia, and the main systems affected were hematologic, nervous, and dermatologic. LEV and OXC caused more nonsevere ADRs, and PHT caused more severe ADRs. The risk analysis showed an association between belonging to the younger groups and polytherapy with ADR presence and between polytherapy and malnutrition with severe ADRs. In addition, most of the severe ADRs were preventable, and most of the nonsevere ADRs were nonpreventable.

Analysis of Adverse Drug Reactions (ADRs) Using Antibiotic for Community Acquired Penumonia (CAP) Disease of Toddler

Pneumonia is an infection that causes inflammation of the lung tissue so that the lung sacs are filled with infectious agents and are the main cause of infant mortality in the world. The initial therapy for pneumonia is the use of antibiotics. Irrational use of antibiotics can lead to ADRs. Adverse Drug Reactions (ADRs) often cause obstacles in the implementation of treatment. The purpose of this study was to see how ADRs influence the use of antibiotics on the clinical outcomes of pneumonia patients. The method analytic observational study using a cross-sectional design which is carried out prospectively, by collecting data on inpatients. Data were obtained from interviews with patients and/or patient families using the Naranjo questionnaire, as well as searches of patient medical records during the period January - March 2023. Analysis of ADRs on the use of antibiotics on outcomes was analyzed by the Likelihood ratio. This study was dominated by patients aged <2 years (61.5%) with improved outcomes (97.15%). The results obtained showed that there was no significant relationship between ADRs using antibiotics and patient outcomes with a p>0.05 (p=0.798). The conclusion of this study is that there is no effect of ADRs using antibiotics on patient outcomes.

Analysis of adverse drug reactions caused by carbapenems and review of related literature

Analysis of adverse drug reactions caused by carbapenems and review of related literature

Predictive modeling of adverse drug reactions to tamoxifen therapy for breast cancer on base of pharmacogenomic testing.

The present study investigated the analysis of adverse drug reactions (ADRs) to tamoxifen (TAM) in breast cancer patients in relation to the carriage of genetic polymorphisms of genes encoding enzymes of CYP system and transporters of P-glycoprotein (Pg) and predictive models based on it. A total of 120 women with breast cancer taking adjuvant TAM were examined for the gene polymorphisms such as CYP2D6*4, CYP3A5*3, CYP2C9*2, CYP2C9*3, CYP2C19*2, CYP2C19*3 and ABCB1 (C3435T). Allelic variants were determined using the real-time polymerase chain reaction method. The research material was double sampling of buccal epithelium. Medical history data and extracts from case histories were used as sources of medical information, on the basis of which questionnaires specially created by us were filled out. An associative analysis showed association with the development of ADRs to TAM indicating their clinical significance from different genetic polymorphisms of CYP2D6, CYP3A5, CYP2C9 and ABCB1. The complex associative analysis performed using mathematical modeling made it possible to build predictive risk models for the development of ADRs such as hot flashes, dyspepsia, bone pain, and asthenia. Models that include both genetic and non-genetic determinants of ADRs of TAM may further improve the prediction of individual response to TAM.

Analysis of adverse drug reactions (ADR) in fluorescein angiography (FAG) and indocyanine green angiography (ICGA) and indications before and during the COVID-19 pandemic at auniversity eye hospital

This study was an analysis of fluorescein angiography (FAG) and indocyanine green angiography (ICGA) at auniversity eye hospital. The primary objective of the study was to analyze adverse drug reactions (ADRs) and their severity (mild, moderate, severe). The secondary objective was to investigate the indications of FAG and ICGA before and during the COVID-19 pandemic. Aretrospective analysis of all FAG and ICGA at the University Eye Hospital in Würzburg from January 2016 to the end of December 2021 was performed. The ADRs, gender, age, examination time points and indications were evaluated. The ADRs were classified into mild, moderate, and severe, following the definition of Kornblau etal. [1] RESULTS: Atotal of 4900 examinations from 4193patients were analyzed. An FAG was performed slightly more frequently in men (54.8%) than in women (45.2%) and the mean age was 63.2 ± 16.9years (median: 65years). The ADRs occurred in only 1.65% of all FAG, of which 1.27% were mild and 0.39% were moderate. No severe ADRs occurred. The most common ADR was nausea at 59.26%. No ADR occurred in ICGA. The annual number of FAGs averaged 816.7 ± 91.1 and was relatively constant throughout the period except for asignificantly reduced number in 2016 (compared with 2018, 2019, and 2021). The most common indication for FAG was venous retinal occlusion at 22.93% (N = 774), showing asignificant increase in 2021 compared to 2018-2020. An ICGA was performed in 4.18% of cases, with the most common indication being uveitis at 31.82% (N = 63). Compared to other studies very few ADRs occurred and no life-threatening ADR occurred in any case. Venous retinal occlusions were very common indications for FAG, probably due to the frequent need for repeated examinations in this condition. Briefly, during the first lockdown (18 March-8 May 2020), adecrease in angiographies was observed, but over alonger period, no significant differences were seen compared with the prepandemic period.

Mining and analysis of adverse drug reactions associated with perampanel based on FAERS database

IntroductionPerampanel (PER) is a non-competitive AMPA glutamate receptor antagonist used as an anti-seizure medication. Large post-marketing databases are still lacking for safety analysis of the new generation of anti-seizure medications. Based on the FDA's adverse event reporting system (FAERS) database, this study aimed to investigate, assess, and offer evidence for the safety of PER to support clinical decision-making. MethodsPerampanel-related adverse reaction signals were mined using the reporting odds ratio (ROR), medicines and healthcare products regulatory agency (MHRA), and Bayesian confidence propagation neural network (BCPNN). The rate and occurrence of reported adverse responses were examined. ResultsWith the three methodologies used in combination, 83 signals mostly related to psychosis and different nervous system disorders were detected. Among them, suicide behavior, respiratory depression, hepatotoxicity, cognitive impairment, and other possible novel signals warranted consideration. Further examination of the age and gender differences in the detected signals revealed that elderly patients should be closely monitored for any change in consciousness and the occurrence of movement disorders; male patients should be observed for negative mental reactions like a personal attack and homicidal ideation; and female patients should be watched for the occurrence of negative reactions in memory, weight, vision, liver function, and other specific areas. ConclusionsThis study found that PER had the risk of causing suicide behavior, respiratory depression, hepatotoxicity, and cognitive impairment among other adverse effects. When used clinically, PER should be closely monitored for the occurrence of adverse effects on mental health and behavior. However, these results should be interpreted with caution.

The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System

ObjectivesThis study was designed to assess the disproportionality analyses of adverse drug reactions (ADRs) related to hydroxychloroquine and remdesivir and how ADR reporting fluctuated during the COVID-19 pandemic. MethodsA retrospective observational study was conducted utilizing the Food and Drug Administration’s Adverse Event Reporting System (FAERS) data between 2019 and 2021. The study was conducted in two phases. In the first phase, all reports associated with the drugs of interest were evaluated to assess all related adverse drug reactions. In the second phase, specific outcomes of interest (i.e., QT prolongation and renal and hepatic events) were determined to study their association with the drugs of interest. A descriptive analysis was conducted for all adverse reactions related to the drugs being studied. In addition, disproportionality analyses were conducted to compute the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean. All analyses were conducted using RStudio. ResultsA total of 9,443 ADR reports related to hydroxychloroquine; 6,160 (71.49) patients were female, and higher percentage of patients of both sexes were over the age of 65 years. QT prolongation (1.48%), pain (1.38%), and arthralgia (1.25%) were most frequently reported ADRs during the COVID-19 pandemic. The association of QT prolongation with use of hydroxychloroquine was statistically significant (ROR 47.28 [95% CI 35.95–62.18]; PRR 42.41 [95% CI 32.25–55.78]; EBGM 16.08; IC 4.95) compared with fluoroquinolone. The outcome was serious medical events in 48.01% of ADR reports; 27.42% required hospitalization and 8.61% resulted in death. Of 6,673 ADR reports related to remdesivir, 3,928 (61.13%) patients were male. During 2020, the top three ADR reports were elevated liver function tests (17.26%), acute kidney injury (5.95%) and death (2.84%). Additionally, 42.71% of ADR reports indicated serious medical events; 19.69% resulted in death and 11.71% indicated hospitalization. The ROR and PRR of hepatic and renal events associated with remdesivir were statistically significant, (4.81 [95% CI 4.46–5.19] and 2.96 [95% CI 2.66–3.29], respectively. ConclusionOur study showed that several serious ADRs were reported with the use of hydroxychloroquine, which resulted in hospitalization and death. Trends with the use of remdesivir were similar, but to a lesser extent. Therefore, this study showed us that off-label use should be based on thorough evidence-based evaluation.

Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database.

Antimicrobial resistance is considered one of the major threats to public health and is an important factor that influences the patient's outcome in the intensive care unit. Pharmacovigilance can help raise awareness of potential drug resistance (DR) or ineffectiveness (DI) through adverse drug reaction reports that are submitted to different spontaneous reporting systems. Based on spontaneous Individual Case Safety Reports from EudraVigilance, we conducted a descriptive analysis of adverse drug reactions associated with meropenem, colistin, and linezolid, with a focus on DR and DI. Of the total adverse drug reactions (ADRs) reported for each analyzed antibiotic by 31 December 2022, between 2.38-8.42% and 4.15-10.14% of the reports were related to DR and DI, respectively. A disproportionality analysis was conducted to evaluate the frequency of reporting adverse drug reactions relevant to the DR and DI of the analyzed antibiotics compared to other antimicrobials. Based on the analysis of the collected data, this study underlines the importance of post-marketing drug safety monitoring in raising a warning signal regarding antimicrobial resistance, thereby potentially contributing to the reduction in antibiotic treatment failure in an intensive care setting.

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Background: Diabetes is characterized by hyperglycemia, a metabolic disorder resulting from defects in insulin secretion, action, or both. The traditional treatment choices available for diabetes include medications that are oral hypoglycemic agents and insulin. Due to the introduction of several medications during the past 20 years, the identification of adverse drug reactions has gained importance. Aim: The aim of this study was to evaluate the adverse drug reactions among diabetic patients and patients’ variables that were linked to the adverse drug reactions. Study Design: Cross-sectional study Place and Duration of Study: This research was done at private clinics in Hyderabad, Pakistan, from August 2021 to January 2022. Methodology: Three hundred and seventy seven participants and the data regarding baseline characteristics of participants, adverse drug reactions reported were analyzed together with the assessment of causality and severity of unwanted reactions. Results: Two hundred and forty one (63.9%) were males and 136 (36.1%) were females. Only 19 (5%) reported adverse drugs reactions. Hypoglycemia was the most commonly reported adverse drug reaction i.e.11 ((57.9%). On causality assessment, most of the adverse drug reactions fell under the category of probable adverse drug reaction i.e.15 (78.9%). Four (21.1%) of them had the doubtful relation with the medications. The majority of the adverse drug reactions that were reported by the participants were found to be moderately severe 13 (68.4%), when analyzed through severity assessment scale. Six (31.6%) were belonged to mildly severe category. Conclusion: The upper age group, male gender, and diabetes duration of more than 5 years were associated with a higher incidence of adverse drug reactions. This study gave in depth analysis of adverse drugs reactions reported in the patients of diabetes mellitus together with the nature of adverse drug reactions reported. A better patient outcome would result from the clinical pharmacist's active participation in adverse drug resistance. Keywords: Adverse drug resistance (ADR), Diabetes mellitus, Hypoglycemia, Severity

Analysis of adverse drug reaction reporting at Hue University of Medicine and Pharmacy Hospital

Background: In Pharmacovigilance, spontaneous reporting of adverse drug reactions is the most common method used in many countries around the world to detect and monitor adverse drug reactions. Among sources of ADR reports, reports performed at health facilities play an important role in detecting adverse drug reactions of newly introduced drugs, serious adverse reactions, and adverse drug reactions which can be detected early. Objectives: (1) To investigate the implementation of adverse drug reaction reporting activities at Hue University of Medicine and Pharmacy Hospital for the period 2017-2019, (2) To analyze activities of reporting adverse reactions of drugs at Hue University of Medicine and Pharmacy Hospital for the period of 2017-2019. Materials and methods: We performed a descriptive cross-sectional study on pharmacists who reported ADR and a total of 138 ADR reports archived at pharmacy department of the hospital. Results and Conclusions: The groups of evaluation criteria for the management organization, resources and communication activities related to the adverse drug reaction reporting were scored over 75% of the maximum. In 2017, the reporting rate compared to the whole country reached 0.62% and decreased to 0.37% in 2019. The proportion of good quality reports increased from 34.62% in 2017 to 91.49% in 2019. Almost ADR reports came from nurses (85.51%). The other beta - lactam antibacterial group was the most reported group of suspect drugs (52.17%). The most reported pairs of drugs - adverse reactions were Ceftriaxon - rash (13.04%), Ceftriaxon - pruritus (7.97%) and Ceftriaxon - vomiting (7.97%). Key words: Pharmacovigilance, adverse drug reactions, medical facility

Analysis of adverse drug reactions of therapy with anticoagulants and basic drugs in coronary heart disease against the background of atrial fibrillation

Annotation. The issue of effectiveness and safety of pharmacotherapy is extremely important for the patient. The doctor’s awareness of the selection of the most compatible drugs makes it possible to reduce the number of adverse drug reactions and increases his adherence to treatment. The purpose of the study is to assess the frequency of adverse drug reactions during therapy with anticoagulants: warfarin, rivaroxaban, dabigatran in the complex therapy of coronary heart disease and atrial fibrillation, if necessary to comply with ESC recommendations. For a comprehensive examination of the patient, the following research methods were used: anamnestic, laboratory screening of key body systems, instrumental, functional diagnostics, survey of the patient according to 60 key parameters of drug tolerance, pharmacogenetic method. Statistical data processing was carried out using variance analysis - One way ANOVA & LSD test. The intergroup reliability of the difference in quantitative values was calculated by % - according to the χ2 criterion. Indicators were evaluated in four comparison groups: Rivoroxaban, Dabigatran, Warfarin group with the presence of a genetic mutation of polymorphic alleles of SYP2C9 (SYP2C9*2, SYP2C9*3), which were associated with a slower metabolism of Warfarin and a higher frequency of hemorrhagic complications; and Warfarin group without mutations. Unfortunately, about 2% of patients have bleeding on the background of the use of 2 or more different anticoagulants in a separate period of time. And about 2.5% have ischemic complications on the background of their admission. From 0.25% to 1% die from complications of such therapy. Among other serious complications, there were complaints about the functioning of the digestive system (dysfunction of the pancreas, liver, biliary tract), nervous system, and kidneys. These complaints were present in all groups, but prevailed in the Warfarin group with an existing mutation, probably due to the slowing of the elimination of drugs metabolized by cytochromes CYP2C9, CYP3A4 or greater influence of interaction with P-glycoprotein (due to interaction with digoxin and statins). This requires additional study in order to optimize ways of correcting unwanted reactions in cariological patients. It is obvious that promising genetic research should also be more widely implemented in medical practice.

Evaluation of Curative Effect and Analysis of Adverse Drug Reaction of Tumor Targeted Drug Therapy

Evaluation of Curative Effect and Analysis of Adverse Drug Reaction of Tumor Targeted Drug Therapy