Frequency Of Adverse Drug Reactions Research Articles

Challenges and opportunities in dentistry regarding adverse drug reactions

Adverse drug reactions (ADRs) are a critical issue in dental practice, significantly impacting patient safety, treatment outcomes, and healthcare costs. This empirical study aims to explore the prevalence, causes, and management of ADRs among dental practitioners in Lucknow, Uttar Pradesh, India. Data were collected through a structured questionnaire distributed to 130 dental practitioners, focusing on the frequency of ADRs, types of drugs involved, management strategies, and barriers to reporting. The results revealed that 84.6% of practitioners encountered ADRs in the past year, with antibiotics (53.8%) and NSAIDs (30.8%) being the most commonly implicated drugs. Allergic reactions were the most frequently reported ADRs (46.2%), followed by gastrointestinal issues (23.1%) and systemic toxicity (15.4%). The primary management strategy was discontinuation of the offending drug (53.8%). Significant barriers to ADR reporting included lack of time (46.2%) and insufficient knowledge (30.8%). Inferential statistics showed no significant association between the type of practice and frequency of ADRs, but a significant association between years of practice and reporting practices, indicating more experienced practitioners are more likely to report ADRs. The study highlights the need for enhanced education and training, interdisciplinary collaboration, and the use of technology to improve ADR management and reporting in dental practice, ultimately aiming to enhance patient safety and treatment outcomes.

Frequency of cutaneous drug reactions in the outpatient dermatology clinic at the National Institute of Cardiology Ignacio Chávez over a ten-year period

Cutaneous adverse drug reactions, or pharmacodermias, are the most common form of adverse drug reactions (ADR). It was our interest to know their epidemiological behavior in a tertiary hospital level in Mexico. We stablished the frequency of ADR in 61 infants and adults hospitalized patients and those seen in the outpatient Dermatology Clinic at the National Institute of Cardiology Ignacio Chávez in Mexico City (INCICh) over a period of 10 years. The most frequently diagnosed pharmacodermias were acneiform dermatitis, cutaneous hyperpigmentation and maculopapular exanthema mainly associated to prednisone, hydroxychloroquine, cephalothin, amiodarone and vitamin B-complex, although we registered less frequently more severe and hazardous reactions. These results were consistent with other reports in our country. Multiple drugs administered at a time was an important causative factor for the ADR. It is necessary for every practitioner to develop skills that permit the identification of these dermatoses in order to correctly manage each case and diminish the morbimortality associated.

Safety Profiles Related to Dosing Errors of Rapid-Acting Insulin Analogs: A Comparative Analysis Using the EudraVigilance Database.

Diabetes is a widespread condition that can lead to multiple and severe complications. Rapid-acting insulin analogs (RAIAs) and long-acting insulin analogs are prescribed for the effective management of diabetes. RAIAs are expected to be associated with a higher number of dosing errors because of their rapid onset, short duration of action, and the need for frequent dosing, compared to other insulin analogs. There are three approved RAIAs on the market: insulin lispro (LIS), insulin aspart (ASP), and insulin glulisine (GLU). The aim of this study is to evaluate the real-world evidence on dosing errors reported for RAIAs in EudraVigilance (EV), an established pharmacovigilance database, in comparison to other insulin analogs and human insulins. A descriptive analysis and a disproportionality analysis were conducted. ASP and LIS were associated with high percentages of adverse drug reactions (ADRs) (22% and 17%, respectively), with over 70% of the reports involving serious ADRs. A higher frequency of cardiac and eye disorder ADRs was observed for LIS compared with ASP and GLU. GLU showed a higher frequency of ADRs in the skin and subcutaneous tissue disorders category. LIS dosing errors accounted for 5% of the total number of cases, while dosing errors for ASP and GLU were less than 3%. The most frequently reported dosing errors involved improper dosing (49%). Although there were fewer dosing errors of RAIAs in comparison to other insulins, the severity of the potential outcome highlights the importance of precise dosing and timing. Improved the monitoring and reporting of these dosing errors could enhance diabetes patient care. Additionally, smart medical devices could improve therapeutic outcomes.

8348 A Rare Case Of Liraglutide-Associated Angioedema Requiring Emergent Intubation

Abstract Disclosure: T. Amin: None. A. Mararenko: None. J. Cheng: None. R. Ong: None. S. Holland: None. K. Hu: None. Introduction: Glucagon-like peptide-1 (GLP-1) receptor agonists are widely used in the management of type 2 diabetes mellitus to enhance glycaemic control. While generally considered safe, recent reports indicate an increasing frequency of adverse drug reactions, with gastrointestinal symptoms such as pancreatitis becoming more prevalent. This case report highlights a rare occurrence of angioedema induced by the GLP-1 receptor agonist, Liraglutide. Case A 58-year-old Type 2 diabetic male presented with rapidly progressing tongue swelling, abdominal discomfort, and watery diarrhea, six hours after initiating Liraglutide therapy. On presentation, he was hemodynamically stable, afebrile, maintaining adequate oxygenation on room air. On examination, the patient was in moderate distress with generalized tongue swelling protruding out, with no swelling of eyelids or lips. No rashes were noted on exposed skin and clear breath sounds without wheezing on lung examination. Due to concern for an impending airway compromise, the patient was intubated. Chart review showed he had an episode of self-resolving tongue swelling a few months back, at which time he was taken off his Angiotensin receptor blocker. 2 weeks ago, he was started on a new brand of GLP-1 receptor agonist (Liraglutide) to achieve optimal glycemic control. No other drug allergies or allergic reactions were reported. C1-Esterase panel, eosinophil count, and inflammatory markers were within normal limits.On admission, Liraglutide was discontinued, he was placed on a basal-bolus insulin regimen, received methylprednisolone, famotidine, and diphenhydramine Subsequent improvement allowed for extubation on the third day, and the patient was discharged with plans to discontinue Liraglutide and an epinephrine pen for precautionary use. Conclusion: This case represents a rare and severe manifestation of angioedema associated with Liraglutide use in a diabetic patient. While angioedema has been infrequently reported with other GLP-1 receptor agonists such as Exenatide and Dulaglutide , our case underscores the importance of clinicians' awareness regarding this potential life-threatening complication with Liraglutide. Post-marketing surveillance data suggest that anaphylactic reactions with Liraglutide may occur rarely, emphasizing the need for vigilance among healthcare providers. Presentation: 6/2/2024

Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase3 Study by Stroke Type and Location.

Central post-stroke pain (CPSP) is a common type of central neuropathic pain (CNeP) that can occur following the onset of stroke. The oral gabapentinoid mirogabalin besylate (mirogabalin) is a selective α2δ ligand that is effective for the treatment of CNeP, including CPSP. However, it is unknown whether the analgesic effect of mirogabalin on CPSP varies in patients with different background factors. This was a post hoc subgroup analysis of a multinational, open-label, long-term phase3 study of mirogabalin for the treatment of CNeP conducted between March 2019 and December 2020. Data from patients with CPSP were stratified by type of stroke (ischemic or hemorrhagic), stroke location (thalamus, putamen, brainstem, or other), presence/absence of motor weakness, median time since stroke (≥ 59 or < 59months), and median duration of CPSP (≥ 55.5 or < 55.5months). Efficacy was assessed with the short-form McGill Pain Questionnaire (SF-MPQ), and treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were recorded. This subanalysis included all 94 patients with CPSP from the phase3 study; all were Japanese, and the mean age was 65.3years. The least squares mean change [95% confidence interval] in SF-MPQ visual analog scale (VAS) score from baseline at week52 (last observation carried forward) was - 17.0 [- 22.1, - 11.9] mm. Among the subgroups, least squares mean changes in SF-MPQ VAS scores were not different. Most TEAEs were mild or moderate; severe TEAEs occurred in six patients (6.4%). Somnolence (25.5%), peripheral edema (13.8%), dizziness (11.7%), and weight gain (6.4%) were the most common ADRs, and the types and frequencies of ADRs were similar among subgroups. Mirogabalin was generally effective and well tolerated in patients with CPSP, regardless of background factors such as stroke type or location, presence/absence of motor weakness, time since stroke, and duration of CPSP. Trial registration number NCT03901352.

Scientific Analysis with a Retrospective Method on the Incidence and Severity of Adverse Drug Reactions in Hospitalized Cancer Patients

Adverse Drug Reactions (ADRs) often result from omissions or inadequate use of preventative measures, making them definitely or probably preventable. Discrepancies between clinical severity and patients' perceptions of ADRs' impact on their well-being highlight the need for targeted interventions. This study focused on the frequency, manifestations, and severity of ADRs from chemotherapeutic agents, utilizing a cross-sectional design with data from ADR reports spanning November 2021 to October 2023 at dr. Saiful Anwar General Hospital, Indonesia. A total of 177 ADRs were analyzed descriptively. Of these, 99 (55.93%) occurred in women, with the highest incidence in the 19–60-year age group (77.40%). The most common malignancies were Chronic Myeloid Leukemia (10.17%), Colorectal Malignancy, and Non-Hodgkin Lymphoma (9.60% each). ADRs related to chemotherapy constituted 41.80%, involving drugs such as cisplatin, oxaliplatin, afatinib, imatinib, and Doxorubicin. The severity distribution was 70.37% mild, 27.16% moderate, and 2.47% severe. Monitoring and reporting these ADRs are crucial for patient safety and preventing recurrence.

Multicentric Post-Marketing Surveillance (PMS) Observational Study of Ascorbic Acid and Zinc Effervescent Tablets in Indian Patients with Vitamin C and Zinc Deficiency.

The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication. This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population. Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The P-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions). The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.<p>.

Promoting Patient Engagement in Adverse Drug Reaction Reporting: A Novel Approach Utilizing Set Induction-Based Skill Questionnaires.

All stakeholders must address the global health concern of an increasing frequency of adverse drug reactions (ADRs), regardless of the practice settings. Adverse drug reactions have been found to be a significant cause of morbidity and death across all age groups, hospital admissions, and a significant financial burden on society and healthcare systems. The main objective of this study was to measure patients' awareness and knowledge of reporting adverse drug reactions using a questionnaire and then to help patients become more aware of and sensitive to reporting ADRs. The current investigation was carried out in the OPD Block of the All India Institute of Medical Sciences in Deoghar using a pre-experimental study with one group pre-test post-test design. One hundred and ninety-nine patients who were visiting different OPDs and IPDs participated in this study. The average age of the 199 study participants was 34.6 years. The majority of participants were male, illiterate and belonged to rural areas. We found a statistically significant difference [-11.90(0.000*)] in the pre-test and post-test knowledge questionnaire scores of the participants, indicating the efficacy of awareness and sensitization for patients on ADR reporting. This survey aims to inform patients about the pharmacovigilance Program in India. The questions are structured in a way that allows patients to reflect and become more selfaware while reading them. They also function as a set introduction to ADR (Adverse Drug Reaction) monitoring centers and increase patient awareness of reporting ADRs.

Incidence and Severity of Adverse Drug Reactions in Medical Intensive Care Unit.

Adverse drug reactions (ADRs) curtail patients' quality of life by virtue of increasing therapeutic complexity and rising multimorbidity. In India, the frequency of ADRs for individual drugs and their economic burdens are rarely evaluated. This study aimed at identifying the incidence and severity of ADRs leading to hospitalization (ADRA) and occurring during a hospital stay (ADRH). The objective of this study is to evaluate the incidence the incidence and severity of ADRs in the ICU and their impact on the duration of hospitalization, along with the cost incurred to treat ADRs in the ICU. Demographic, clinical, and pharmacological data on patients admitted to the ICU were collected, analyzed and evaluated for ADRs. According to the setting analyzed, a descriptive analysis of the reactions, suspected medicines, and associated factors was undertaken. A total of 208 patients were admitted to the ICU during the study period, of which ADRA contributed 9.1% of the incidence rate and 8.1% of ADRH in 36 patients. Males had a higher incidence of ADRs than females. Patients who had ADRs had a substantially longer length of stay than those who did not. Electrolyte disturbance was the most commonly found ADR. According to the Hartwig scale and WHO-causality scale, 88.9% were moderate, and 97.2% were possible ADRs, respectively. In this study, a similar incidence rate of ADRA and ADRH was observed. The average cost for treating ADRA was higher than that for treating ADRH. As a result, identifying and preventing these reactions is critical, as they cause the patient greater suffering.

Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors

BackgroundPaediatric patients are especially prone to experiencing adverse drug reactions (ADRs), and the surgical environment gathers many conditions for such reactions to occur. Additionally, little information exists in the literature on ADRs in the paediatric surgical population. We aimed to quantify the ADR frequency in this population, and to investigate the characteristics and risk factors associated with ADR development.MethodsA prospective observational study was conducted in a cohort of 311 paediatric patients, aged 1–16 years, admitted for surgery at a tertiary referral hospital in Spain (2019–2021). Incidence rates were used to assess ADR frequency. Odds ratios (ORs) were calculated to evaluate the influence of potential risk factors on ADR development.ResultsDistinct ADRs (103) were detected in 80 patients (25.7%). The most frequent being hypotension (N = 32; 35%), nausea (N = 16; 15.5%), and emergence delirium (N = 16; 15.5%). Most ADRs occurred because of drug-drug interactions. The combination of sevoflurane and fentanyl was responsible for most of these events (N = 32; 31.1%). The variable most robustly associated to ADR development, was the number of off-label drugs prescribed per patient (OR = 2.99; 95% CI 1.73 to 5.16), followed by the number of drugs prescribed per patient (OR = 1.26, 95% CI 1.13 to 1.41), and older age (OR = 1.26, 95% CI 1.07 to 1.49). The severity of ADRs was assessed according to the criteria of Venulet and the Spanish Pharmacovigilance System. According to both methods, only four ADRs (3.9%) were considered serious.ConclusionsADRs have a high incidence rate in the paediatric surgical population. The off-label use of drugs is a key risk factor for ADRs development.

Effect of pharmacogenomic testing on the clinical treatment of patients with depressive disorder: A randomized clinical trial

BackgroundPharmacotherapy is one of the primary treatment modalities for depression. However, there is considerable variability in the individual response to antidepressant medications. Personalized medicine guided by pharmacogenomic testing may hold promise in addressing this issue. MethodsIn this study, 665 depressive patients were randomly enrolled into two groups: the pharmacogenomic testing group (n = 333) and the control group (n = 332). In the testing group, participants underwent pharmacogenomic testing, and clinicians customized the treatment plan with the result, while the control group relied solely on clinicians' experience. The primary outcomes were the proportion of remission and response, assessed with Hamilton Depression Rating Scale (HDRS). The secondary outcomes included changes in HDRS scores over time and frequency of adverse drug reactions by the participants. ResultsAt week 8, the pharmacogenomic testing group showed significantly higher remission rates (24.0 % v.s. 15.1 %; RR = 1.117; P = 0.007) and response rates (39.3 % v.s. 25.7 %; RR = 1.225; P < 0.001) compared to the control group. By week 12, the pharmacogenomic testing group continued to demonstrate significant advantages in remission (31.0 % v.s. 20.0 %; RR = 1.159; P = 0.003) and response (48.7 % v.s. 37.3 %; RR = 1.224; P = 0.006). Additionally, adverse drug reactions were less frequent in the pharmacogenomic testing group. LimitationsThis study is not blind to clinicians and it's a single-center study.Conclusions: Pharmacogenomic testing-guided drug therapy can provide greater assistance in the treatment of depression.

Evaluation of acceptance and preference of topical lidocaine application versus articaine injection anesthesia after nonsurgical periodontal treatment: A randomized clinical trial.

To compare acceptance and preference of topical lidocaine gel anesthesia with articaine injection anesthesia in patients with moderate periodontitis undergoing scaling and root debridement. Ninety-one patients completed this randomized multicenter split-mouth controlled study and underwent two separate periodontal treatment sessions on different days, one with a topical intrapocket lidocaine gel application and the other with an articaine injection anesthesia in a different order depending on randomization. Parameters measured were the patients' preference for topical lidocaine gel anesthesia or injection anesthesia with articaine (primary efficacy criterion), their maximum and average pain, and their intensity of numbness as well as experience of side effects; the probing depth; and the dentists' preference and their evaluations of handling/application, onset and duration of anesthetic effect, and patient compliance. After having experienced both alternatives, 58.3% of the patients preferred the topical lidocaine gel instillation into the periodontal pockets. The safety profile of the lidocaine gel differed positively from the safety profile of articaine injection in type and frequency of adverse drug reactions. The dentists' acceptance and preference regarding either anesthetic method studied were balanced. Instillation of lidocaine gel into the periodontal pocket is a preferred alternative to injection anesthesia for most of the patients and an equivalent alternative for dentists in nonsurgical periodontal therapy.

Influence of ABCB1 3435C&gt;T Polymorphism on Methotrexate Safety in Patients with Psoriasis — A Secondary Publication

Background: Methotrexate is a highly effective systemic treatment for moderate to severe psoriasis, but drug toxicity may limit its use. Recent evidence suggests that it is necessary to take into account the individual characteristics of methotrexate pharmacokinetics, which are determined by the presence of polymorphisms of genes encoding methotrexate carrier proteins, to predict the risk of methotrexate-induced toxicity. Aim: The research aims to assess the associations of ABCB1 rs1045642 (3435C&gt;T) polymorphism with methotrexate safety for patients with moderate and severe psoriasis. Methods: The study included 75 psoriasis patients treated with methotrexate with 21 days of follow-up duration. Data on adverse drug reactions (ADR) were collected using a clinically structured questionnaire, and complete and biochemical blood tests, and urinalysis were performed. The severity of ADR was assessed using visual analog scales and the CTCAE toxicity scale. The severity of gastrointestinal ADR was assessed using the GSRS questionnaire. Genotyping was carried out by real-time PCR. Results: Gastrointestinal toxicity was detected in 38 patients (50.67%). The mean GSRS score was 7.97 ± 9.18. Analysis of differences in the ADR incidence showed the presence of statistically significant differences in the frequency of ADR in the gastrointestinal tract: the toxic effect of methotrexate was more often observed in carriers of the T allele of the ABCB1 rs1045642 polymorphism (3435C&gt;T), (CC: 2 (14.3%), TC: 18 (52.9%), TT: 18 (66.7%), P = 0.006). Binomial regression demonstrated the presence of a statistically significant effect of the rs1045642 single-nucleotide polymorphism of the ABCB1 gene on the incidence of ADR from the gastrointestinal tract (OR = 8.64, P = 0.008). Conclusion: An association of ABCB1 rs1045642 single-nucleotide polymorphism with the safety of methotrexate therapy in patients with moderate and severe psoriasis was revealed. The data obtained can be used to personalize the prescription of methotrexate to psoriasis patients.

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study.

In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021-February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee's characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.

Cutaneous Adverse Drug Reactions: Regional Experience of a Global Challenge.

Adverse drug reactions (ADR) are considered any harmful and unintended side effects associated with the use of a drug at the usual therapeutic dose, in which skin is involved in most cases. Therefore, the availability of epidemiological information on reactions, reaction patterns, and their causative drugs can be helpful in timely diagnosis and necessary measures, such as caution in prescribing causative drugs to prevent these types of reactions. In this retrospective descriptive study, the archived files of patients with dermatoses due to ADR referred to Taleghani University Hospital, Urmia, Iran, during 2015-2020 were studied. Patterns and frequency of skin reactions, demographic data, and the frequency of chronic comorbidities were identified. A total of 50 patients with drug-induced skin rash were found, of which 14 were male (28%) and 36 were female (72%). Skin rashes were most frequently found in patients aged 31-40 years. In 76% of patients, there was at least one chronic underlying disease. The most common reaction pattern was maculopapular rash (44%), and the most common causative drugs were antiepileptic drugs (34%) and antibiotics (22%). Mortality was found in 4 cases, which was due to antibiotics and antiepileptic drugs that caused toxic SJS/TEN and erythroderma. The hospital stays were highest in SJS and lowest in a maculopapular rash. Knowledge about the epidemiology and the frequency of adverse drug reactions may be helpful in increasing the awareness of physicians for correct and rational drug prescriptions, which can reduce unnecessary hospital referrals and treatment costs.

Factors influencing early recurrence of atrial fibrillation among elderly patients following radiofrequency catheter ablation and the impact of different antiarrhythmic regimens.

Patients with atrial fibrillation (AF) who undergo radiofrequency catheter ablation (RFCA) necessitate the administration of antiarrhythmic drugs to prevent early recurrence. The clinical outcomes among these patients may be influenced by varying antiarrhythmic regimens. To identify the risk factors associated with early recurrence and compare the clinical outcomes among different antiarrhythmic regimens in elderly patients with AF following radiofrequency catheter ablation (RFCA) during a 3-month period. A retrospective observational study encompassed 420 elderly patients with AF following RFCA. Baseline data were collected during the initial postoperative visit and clinical outcomes were carefully monitored over a 3-month follow-up period. Logistic regression and Cox-proportional hazard regression analyses were performed to investigate the relationship between various antiarrhythmic regimens and the clinical outcomes. Multivariate logistic regression analysis revealed that age (p = 0.001), left atrial diameter (p < 0.001), left ventricular diameter (p = 0.015), reactive hyperemia index (RHI) (p < 0.001), antiarrhythmic drug (p < 0.001) and hs-cTnI (p = 0.017) were independent risk factors of early recurrence. Furthermore, in cox survival regression analysis model, survival rate of early recurrence in the amiodarone group was higher than in the propafenone group (HR 2.30, 95%CI 1.17-4.53, p = 0.016) and in the sotalol group (HR 3.60, 95%CI 2.17-5.95, p < 0.001). Compared to the amiodarone group, the incidence of liver dysfunction was lower in the dronedarone group (p = 0.046) and the propafenone group (p = 0.021). The incidence of bradyarrhythmia (p = 0.003), QT interval prolongation (p = 0.035) and atrioventricular transmission block (p = 0.021) were higher in the sotalol group than in the amiodarone group. RHI was identified as an independent risk factor for early recurrence among elderly AF patients after RFCA. Compared to amiodarone, propafenone and sotalol exhibited an elevated risk of early recurrence. Although there was no significant difference in early recurrence between amiodarone and dronedarone, dronedarone emerged as the preferred option due to its lower frequency of adverse drug reactions than amiodarone.

Exploring Drug Utilization Patterns and Adverse Drug Reactions in the Management of Osteoarthritis: A Prospective Study

Aim/Background Osteoarthritis (OA) is a degenerative joint disease characterized by pain and functional impairment, leading to significant healthcare challenges. Pharmacological management, including NSAIDs, analgesics, disease-modifying osteoarthritis drugs (DMOADs), and corticosteroids, is commonly used. However, limited data exist on drug utilization patterns and adverse drug reactions (ADRs) in OA treatment. This study aimed to evaluate these patterns and identify potential ADRs in patients with OA. Methods This prospective study included OA patients from diverse backgrounds. Baseline demographic data, disease severity, and treatment history were recorded. Drug utilization was monitored, focusing on NSAIDs, analgesics, DMOADs, corticosteroids, and alternative therapies. ADRs were identified through patient self-reports, clinician observations, and medical record reviews. Statistical analysis examined drug prescription trends, ADR frequency, severity, and associated risk factors. Results NSAIDs were the most frequently prescribed drugs (44.45%), followed by analgesics and DMOADs. Gastrointestinal discomfort was the most commonly reported ADR, particularly among NSAID users. Corticosteroids were linked to systemic side effects in a minority of patients. Advanced age, longer treatment duration, and existing gastrointestinal conditions were significant risk factors for ADRs. Conclusion The study underscores the widespread use of NSAIDs in OA treatment and highlights the need for careful monitoring due to potential ADRs, especially gastrointestinal issues. Identifying risk factors helps clinicians make informed prescribing decisions, improving patient outcomes and minimizing ADRs. Future research should focus on optimizing drug therapies to ensure better safety and efficacy in OA management.

ПЕРЕНОСИМОСТЬ ПРОТИВОТУБЕРКУЛЕЗНОЙ ТЕРАПИИ У ДЕТЕЙ

Objective: to evaluate tolerability of different chemotherapy regimens in children with pulmonary TB and input of second-line drugs to the development of adverse drug reactions (ADR). Materials and methods. The study enrolled 92 children aged 2–12 years (a median of 6 years of age) with newly diagnosed active pulmonary TB, who received treatment in 2019–2022. The initial drug combination was based on drug susceptibility of both infection source and patient (chemotherapy regimens 1/3, 2 and 4/5); the number of TB drugs and chemotherapy duration was determined by severity of TB process. The patients were divided into groups based on the chemotherapy regimen: group 1 included 29 patients only administered first-line drugs (1/3), 16 patients of group 2 received chemotherapy regimen 2, and 47 patients of group 3 received 4/5 chemotherapy regimen. Results. ADR were observed in 61 of 92 children (66,3%); satisfactory tolerability was observed in 31 children (33.7%). ADR occurred most frequently in patients of group 3 (85.1%) compared to group 2 (68.8%) and group 1 (34.5%) (χ2 = 20.624, p &lt; 0.001). ADR, which required withdrawal of the offending drug, were more frequent among children, who received chemotherapy regimen 4/5 or 2 (55.3% and 50.0% respectively) compared to children, who received chemotherapy regimen 1/3 (10.3%) (χ2 = 15,372, p = 0,001). Allergic reactions were reliably more frequent under chemotherapy regimen 4/5 compared to chemotherapy regimen 1/3 (31.9% and 6.9% respectively) (χ2 = 6,464, p &lt; 0,012). Clinical and laboratory manifestations of allergic reactions were identical and did not depend on the chemotherapy regimen. Toxic reactions were reliably more frequent under chemotherapy regimen 4/5 compared to 1/3 (48.9% and 20.8% respectively) (χ2 = 6.064, p = 0.014). The range of toxic reactions increased under administration of second-line drugs and demonstrated more clinical and laboratory manifestations under chemotherapy regimen 4/5. Intractable ADR most frequently occurred under administration of amikacin/capreomycin (41.7%), protionamide (30.0%), levofloxacin/moxifloxacin (17.0%), or cycloserine (11.6%). Conclusion. The frequency of ADR to TB treatment in children depends on the administered drugs. The least incidence of adverse reactions was observed in patients, who received first ling drugs (chemotherapy regimen 1/3). Toxic reactions prevailed over allergic ones. The range of toxic reactions increased in patients, who received second-line drugs.

Pattern of Adverse Drug Reactions at a Tertiary Care Hospital, Kerala, India: A Cross-sectional Study

Introduction: With the rising use of medications, Adverse Drug Reactions (ADRs) have emerged as a significant public health issue. Therefore, establishing a robust pharmacovigilance system across the nation has become imperative. The present study focussed to analyse the trends and frequency of ADRs to enhance the safety of drug prescriptions and ensure public health protection. Aim: To assess the pattern of adverse effects, drugs implicated, causality, severity, and outcomes of ADRs reported to the ADR monitoring centre in the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India. Materials and Methods: This was a cross-sectional study in which 262 ADRs reported to the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India from May 2022 to April 2023 were analysed for patient demographics, drug and ADR characteristics, and the outcomes of the ADR. Causality and severity assessments of these ADRs were performed using the World Health Organisation (WHO)-Uppsala Monitoring Centre (UMC) scale and the modified Hartwig and Siegel’s scale, respectively. Data were tabulated using Microsoft Excel and expressed as mean, standard deviation, frequency, and percentage as appropriate, with the help of descriptive statistics using Epi Info 7 software. Results: A total of 262 ADRs were analysed. The mean age of the patients was 47.4±20.1 years. The majority were females 160 (61.1%). The intravenous route was the most common route involved in ADRs 158 (59.8%), followed by the oral route 91 (34.5%). Skin reactions accounted for more than half of the ADRs 151 (53.2%), followed by blood dyscrasias 48 (16.9%). Antibiotics were the most common group of implicated drugs 124 (44.9%), followed by anticancer drugs 43 (15.6%) and antitubercular drugs 34 (12.3%). Among antibiotics, cephalosporins (36.3%) were the most frequently encountered, followed by penicillins (30.6%). A total of 148 patients (56.5%) had recovered by the day of reporting, 146 (55.7%) ADRs were found to be ‘possible’ using the WHO-UMC causality scale, and 144 (54.9%) ADRs were classified as moderate severity. Conclusion: The study identified a widespread occurrence of ADRs, some of which increased healthcare costs due to prolonged hospital stays. The high incidence of ADRs from antimicrobials is concerning, as it contributes to antimicrobial resistance. This underscores the urgent need for prudent antimicrobial usage. The present study emphasises the importance of ADR reporting among healthcare workers and the necessity for hospitals to establish ADR reporting strategies for optimal patient care.

Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System.

Anti-disialoganglioside (anti-GD2) monoclonal antibodies are effective immunotherapeutic drugs for treating neuroblastoma, yet their toxicity spectrum is unclear. This study aimed to assess the toxicity profiles of three anti-GD2 monoclonal antibodies (dinutuximab, dinutuximab β, and naxitamab) in clinical applications by mining and evaluating the adverse drug reaction (ADR) signals from the US Food and Drug Administration Adverse Event Reporting System. Data in the US Food and Drug Administration Adverse Event Reporting System from the time anti-GD2 monoclonal antibodies became available in the market to the first quarter of 2023 were searched. The signals of anti-GD2 monoclonal antibody-associated ADRs were quantified using four types of algorithms, including the reporting odds ratio, the proportional reporting ratio, the combination of the proportional reporting ratio and χ2 statistic method used by the UK Medicines and Healthcare Products Regulatory Agency, and the Bayesian confidence propagation neural network. The ADRs were categorized by System Organ Class based on the Medical Dictionary for Regulatory Activities, and were sorted according to the frequency and signal strength of ADRs. A total of 370 adverse drug event reports with anti-GD2 monoclonal antibodies listed as the 'primary suspected drugs' were identified, with 116 ADR signals detected, of which 22 were not in the drug labels. Among the adverse drug event reports, 276 reports concerned dinutuximab/dinutuximab β as primary suspected drugs with 90 ADR signals, involving 19 System Organ Classes, of which 21 signals were not in the label; 94 adverse drug event reports concerned naxitamab as the primary suspected drug with 26 ADR signals, involving 11 System Organ Classes, of which one was not in the label. For dinutuximab/dinutuximab β-related ADRs, the top five most frequent were "fever", "abdominal pain", "elevated aspartate aminotransferase (AST)", "elevated alanine aminotransferase (ALT)" and "hypotension"; the top five most intensive signals were "hypoalbuminemia", "elevated AST", "capillary leakage syndrome", "hypoxia" and "elevated ALT". For naxitamab-related ADRs, the top five most frequent were "hypotension", "pain", "urticarial", "hypertension" and "rash"; the top five most intensive signals were "hypotension", "urticaria", "hypoxemia", "bronchospasm" and "hypertension". Involved System Organ Classes included "investigations" and "respiratory, thoracic and mediastinal disorders" containing the most types of ADR signals in dinutuximab/dintuximab β-related ADRs and naxitamab-related ADRs, respectively. Our study comprehensively analyzed the toxicity profiles of anti-GD2 monoclonal antibodies and provides an important reference for clinical monitoring and ADR identification of these drugs.