Search Results (12)

(1) Background: The occurrence, intensity, and characteristics of adverse drug reactions (ADRs) caused by anti-tuberculosis (TB) drugs have consistently been a subject of worry. There is a lack of published research from Pakistan regarding the negative effects of anti-TB treatment on children, specifically about ADRs. In this study, we aimed to investigate the ADR associated with anti-DR-TB treatment in children. (2) Methods: A prospective longitudinal study was conducted in the multicenter setting of Khyber Pakhtunkhwa, Pakistan. A total of 450 TB children in multicenter hospitals under ATT were assessed for ADRs. Naranjo Causality Assessment and Hartwig’s Severity Assessment Scale were used to evaluate the causality and severity. (3) Results: A total of 300 (66.66%) ADRs were reported in 450 people with DRTB. Anemia was the most frequently observed ADR (37.6%) followed by nausea and vomiting (18.6%). On multivariate analysis, the independent variables that had a statistically significant positive association with ADRs were participants aged, 5–14 years (AOR, 0.3 (0.1–0.5), p ≤ 0.001), normal weight (1.1 (2.0–1.9), p < 0.001), and children having comorbidities (AOR, 0.5 (0.1–0.8), p ≤ 0.001). (4) Conclusions: Our findings advocate for personalized treatment approaches, incorporating nutritional support, comprehensive comorbidity management, and vigilant monitoring to mitigate ADRs and improve treatment outcomes. Full article

Background: Older adults are vulnerable to adverse drug reactions (ADRs), particularly in low-income settings, yet data on ADR prevalence in Africa, including Ethiopia, remain limited. Objective: This study aimed to evaluate the incidence, severity, and preventability of ADRs among hospitalized older adults, as well as all-cause inpatient mortality. Methods: A cross-sectional observational study was conducted at Jimma Medical Center, located in Jimma town, Ethiopia, from 6 September 2021 to 26 December 2022. The study participants were older adults (n = 162) admitted to the medical wards. ADRs were assessed using the Naranjo ADR probability scale, severity was classified according to the modified Hartwig and Siegel criteria, and preventability was determined using the Schumock and Thornton criteria. Results: The median age of participants was 65 years (interquartile range: 60–70). During their hospital stay, 84 patients (51.9%) experienced at least one ADR. A total of 123 ADRs (76 ADRs per 100 admissions) were captured. Most ADRs (93.5%) were classified as mild to moderate in severity, and 84.5% (n = 105) were considered preventable. Endocrine and metabolic systems (48.8%) and diuretics (43.9%) were the most frequently affected organ systems and drug class linked to ADRs, respectively. Furosemide (41.5%) and aspirin (10.6%) were the most frequently implicated medications, commonly causing hypokalemia (35.3%) and dyspepsia (53.8%), respectively. The observed all-cause in-patient mortality rate was 6.8% (5 deaths per 1000 patient-days). The use of potentially inappropriate medications (PIMs) (aOR: 4.747, p = 0.003) and presence of digestive system disorders (aOR: 8.784, p = 0.038) were associated with an increased risk of ADRs, while a history of recent traditional medicine use (aOR: 0.285, p = 0.042) was linked to a lower risk. Conclusions: More than half of the hospitalized older adults experienced ADRs, most of which were mild to moderate in severity and considered preventable. Regular medication review for screening and minimizing PIM use in older adults may play a crucial role in lowering ADR occurrence. The borderline but statistically significant association between a history of traditional medicine use and lower occurrence of ADRs requires cautious interpretation and further investigation to explore possible explanations. Nearly seven deaths per hundred hospitalized patients were recorded. Full article

Background: Adverse drug reactions have been reported as leading causes of morbidity and mortality. Unfractionated heparin- and low-molecular-weight heparin-induced hyperkalemia are side effects that have been reported in approximately 7 to 8% of heparin-treated patients. Algorithms, assessment tools, and decision aids are needed to assist in determining the causality of these adverse drug reactions. Aim: The aim of this study was to determine the number of case reports of hyperkalemia resulting from unfractionated heparin or low-molecular-weight heparin use by utilizing the Naranjo Adverse Drug Reaction Probability Scale. Methods: PubMed, International Pharmaceutical Abstracts, and the Cochrane Library were searched for relevant publications. Search terms and Boolean operators, including “hyperkalemia AND heparin”, “hyperkalemia AND low molecular weight heparin”, “heparin AND hypoaldosteronism”, and “low molecular weight heparin AND hypoaldosteronism”, were used. Searches were limited to case reports and human specimens. Results: A total of 29 case reports were identified, incorporating 38 patient cases. Of the 38 patient cases, 5 [4 involving unfractionated heparin and 1 involving low-molecular-weight heparin] (13.2%) utilized the Naranjo Adverse Drug Reaction Probability Scale to identify the possibility of an adverse drug reaction occurring due to exposure to unfractionated or low-molecular-weight heparin as probable. Conclusions: The available evidence suggests that clinicians’ use of the Naranjo Adverse Drug Reaction Probability Scale to determine the potential of hyperkalemia occurring due to exposure to unfractionated heparin and low-molecular-weight heparin is limited. Clinicians should be encouraged to utilize an objective monitoring tool to help standardize assessment of causality for all adverse drug reactions. Full article

Background: Among rheumatologic diseases following therapy with immune checkpoint inhibitors (ICIs), the cases of cancer patients diagnosed as having polymyalgia rheumatica (PMR), particularly with nivolumab and pembrolizumab, has been steadily rising in published reports. Objectives: We performed a systematic review of published case reports with the aim of answering these questions: (1) Is PMR following therapy with nivolumab and pembrolizumab an adverse drug reaction (ADR)? (2) Is there a difference between cases of PMR following therapy with nivolumab and those following therapy with pembrolizumab? Methods: Based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive literature search in three main bibliographic databases: MEDLINE (Ovid interface), EMBASE, and COCHRANE Library was carried out on 27 December 2024. This systematic review has no registration number. Results: Data were extracted from 12 patients. Namely, 5 cases followed treatment with nivolumab and 7 with pembrolizumab. Validated scales for ADR assessment—such as Naranjo’s scale—were not used in 10 out of the 12 patients. Additionally, validated diagnostic or classification criteria for PMR were used in the majority of case reports related to nivolumab. On the contrary, clinical judgment alone was the rule in almost all case reports on pembrolizumab. Finally, the time interval between PMR manifestations and nivolumab/pembrolizumab therapy ranged from one to 14 cycles (fully compatible with pharmacokinetics). Conclusions: Our literature review highlighted significant methodological blurred lines in the categorization of PMR following therapy with nivolumab or pembrolizumab. Full article

Several studies have suggested that probiotics could play a role in the management of patients with chronic bacterial prostatitis (CBP). In this randomized, placebo-controlled clinical study, we evaluated the efficacy and safety of consumption of probiotics containing human Lactobacillus casei DG^® as an add-on treatment in patients with clinical recurrences of CBP, through gut microbiota modification analysis. Enrolled patients with CBP were randomized to receive for 3 months probiotics containing human Lactobacillus casei DG^® or placebo following 1 month treatment with ciprofloxacin. During the enrollment and follow-ups, urological examinations analyzed symptoms and quality of life, while microbiological tests analyzed gut and seminal microbiota. During the study, the development of adverse drug reactions was evaluated through the Naranjo scale. Twenty-four patients with CBP were recruited and treated for 3 months with placebo (n. 12) or with Lactobacillus casei DG^® (n. 12). Lactobacillus casei DG^® induced a significantly (p < 0.01) faster recovery of symptoms than placebo (2 days vs. 8 days) and an increased time free from symptoms (86 days vs. 42 days) without the occurrence of adverse events. In the probiotic group, the appearance of Lactobacilli after 30 days (T1) was higher vs. the placebo group, and a significant reduction in Corynebacterium, Peptoniphilus, Pseudomonas, Veillonella, Staphylococcus, and Streptococcus was also observed. These preliminary data suggest that in patients with CBP, the use of Lactobacillus casei DG after an antimicrobial treatment improves the days free of symptoms and the quality of life, without the development of adverse drug reactions. Full article

Background: Duloxetine, a Serotonin–Norepinephrine Reuptake Inhibitor (SNRI), is frequently used to treat diabetic peripheral neuropathy, depression, and fibromyalgia. However, its long-term cardiovascular implications in older individuals remain underexplored, particularly in those with pre-existing cardiovascular diseases. This medical record assessment aimed to evaluate the potential cardiovascular risks of duloxetine use in older persons after prolonged use. Methods: We evaluated adverse drug reactions (ADRs) using six medical records from elderly individuals (aged 70–79) with cardiovascular comorbidities who received duloxetine (≥60 mg daily) for anxiety, depression, and chronic pain. ADRs were assessed using the Naranjo ADR Probability Scale, the Modified Hartwig and Siegel Severity Scale, and the Karch and Lasagna Algorithm. Clinical outcomes were assessed before and after duloxetine dose reduction or withdrawal. Results: All the patients had cardiovascular-related ADRs, such as peripheral cyanosis, vasoconstriction, atrial fibrillation, and hypertensive episodes. Five of the six patients experienced mild cognitive impairment [Montreal Cognitive Assessment (MoCA) scores of 11–24/30]. A positive dechallenge (symptom resolution) was observed in all medical records after decreasing or discontinuing duloxetine. It is interesting to note that four medical records demonstrated significant improvement in cyanosis, blood pressure, and anxiety after decreasing or discontinuing duloxetine use. There was no rechallenge in this study. The causality was considered probable (Naranjo Scale), and ADRs were categorized as moderately severe (Hartwig and Siegel Scale) in all the medical records. However, with adequate monitoring, the ADRs were considered preventable (Schumock and Thornton Scale). Conclusions: Long-term duloxetine use could cause significant cardiovascular problems in older individuals, particularly those who already have cardiovascular difficulties. Regular monitoring of cardiovascular function and early steps such as dose adjustment or drug withdrawal of duloxetine may reduce the prognosis of ADRs. More studies are required to create safer treatment strategies for managing depression and anxiety in older people with cardiovascular issues. Full article

Introduction: Type 2 diabetes mellitus (T2DM) is a common disease burdened with significant morbidity and mortality. Despite the substantial number of new available drug treatments, adherence to therapy and adverse drug reactions (ADRs) are the major constraint in the management of this disease. We evaluated the use, the adherence, and the safety of antidiabetic drugs in patients with T2DM. Methods: We performed an observational, retrospective, multicenter study on medical records of outpatients referred to general practitioners in Catanzaro (Calabria, Italy). Drug adherence was measured considering the packages of antidiabetic drugs prescribed at the time of admission, after three months, and 1 year later. ADRs were evaluated using the Naranjo probability scale. Collected data were analyzed using the Statistical Package for the Social Sciences. Results: During the study, we evaluated 12,170 medical records of seven general practitioners. The most prescribed drug was metformin alone (28.4%) or with other oral antidiabetics (19.6%) and then insulin (n: 354; men 190, women 164). Logistic regression showed an association between T2DM less than or equal to 5 years and low adherence (p = 0.023). During the study, we recorded 26 ADRs that were correlated with sex (women) and insulin treatment. Conclusions: this real-life study shows that patients with T2DM have a high adherence, probably related to their having a low number of ADRs. Full article

Introduction: Drug treatment can be related to the development of adverse drug reactions (ADRs). Aim: In this paper, we evaluated ADRs in patients admitted to the Ambulatory of Pain Medicine of the University Hospital Renato Dulbecco in Catanzaro. Methods: We conducted a prospective analysis between 1 February 2021 and 20 July 2023 on patients with neuropathic pain referred to the Ambulatory of Pain Medicine of “Renato Dulbecco” University Hospital in Catanzaro (Calabria, Italy). Patients aged >18 years with clinical signs of neurologic pain and a score upon completing the Douleur Neuropathique en 4 Questions (DN4) questionnaire of ≥4 were included. The association between drugs and ADR or between drugs and drug–drug-interactions (DDIs) was evaluated using Naranjo’s probability scale and Drug Interaction Probability Scale (DIPS), respectively. Results: During the study period, we analyzed 2370 patients referred to the ambulatory of pain medicine. After the evaluation of inclusion and exclusion criteria, 33.5% of patients were enrolled. All patients presented at least one comorbidity and daily used a mean of five drugs (range 3–11). Using the Naranjo score, the development of ADRs was documented in 112 patients (score 6). Using parametric and non-parametric statistical analysis, we failed to report an association between ADR and dosage or ADR and patient characteristics. Conclusion: Our results show the development of ADRs in 18% of patients with neuropathic pain. This low percentage of drug interaction could be a limitation in real life because it is probably due to the site of the study and the appropriate prescription of drugs. Therefore, it shows that it is necessary to motivate healthcare to pay attention to the prescription of drugs in poly-treated patients to reduce the risk of ADRs. Full article

Since the COVID-19 outbreak began, an association between COVID-19 and thrombotic diseases has been underlined. Although this association is more frequent with venous thromboembolism, ischaemic stroke has also been reported as a thrombotic complication in several cohorts of affected patients. Furthermore, the association between ischaemic stroke and COVID-19 has been considered a risk factor for early mortality. On the other hand, after the successful vaccination campaign, the incidence and the virulence of SARS-CoV-2 decreased, though it has been observed that COVID-19 may induce a severe infection in specific cohorts of frail subjects. For this reason, different drugs have been introduced of an antiviral action in order to improve the disease outcome of frail patients. In this field, with the arrival of a neutralizing monoclonal antibody against SARS-CoV-2, in particular, sotrovimab, a further chance to treat high-risk patients with mild-to-moderate COVID-19 arrived, achieving a concrete reduction in the risk of disease progression. We here report our clinical experience of an ischaemic stroke occurring a few minutes after the administration of sotrovimab for the treatment of moderate COVID-19 in a frail patient with chronic lymphocytic leukaemia. Other causes of ischaemic stroke were ruled out, and in order to evaluate the probability of a rare side effect, the Naranjo probability scale has also been utilized. In conclusion, among several side effects that have been described during the treatment of COVID-19 with sotrovimab, ischaemic stroke was not reported. Therefore, we here report a rare case of ischaemic stroke with early clinical manifestation after the administration of sotrovimab for the treatment of moderate COVID-19 in an immunocompromised patient for the first time. Full article

Background: Over the years, forensic pathology has registered the spread of new methods of suicide, such as the ingestion of sodium nitrite. Sodium nitrite causes increased methemoglobin, resulting in systemic hypoxia, metabolic acidosis, and cyanosis. Since sodium nitrite is a preservative, the ingestion of foods containing an excessive amount of this substance can also cause acute intoxication up to death. The present review is aimed at guiding health professionals in the identification and management of sodium-nitrite-related intoxications and deaths. Methods: A systematic literature search was carried out on PubMed by following the PRISMA statement’s criteria. A total of 35 studies with 132 cases were enrolled, and the data were cataloged in Microsoft Excel. To establish the causal correlation between sodium nitrite ingestion and death, the Naranjo Adverse Drug Reaction Probability Scale was used. Results: In addition to the small number of cases that have currently been published, the study demonstrated that there was a general methodological discrepancy in the diagnostic process. However, some interesting results have emerged, especially in post-mortem diagnostics. Conclusion: Sodium-nitrite-related deaths represent a challenge for forensic pathologists; therefore, it is important to promptly recognize the essential features and perform the necessary and unrepeatable examinations for the correct diagnosis of the cause of death. Full article

Acute kidney injury is a reversible medical condition commonly caused by nephrotoxic agents. The infrequency that a nebulized medication elicits a renal insult presents a rare diagnostic challenge. Within this case, we report a 57-year-old cystic fibrosis patient with chronic kidney disease (CKD) Stage G3b (baseline 1.5–1.6 mg/dL) who developed an acute kidney injury (AKI) with a serum creatinine elevation to 4.08 mg/dL and associated worsening vestibular dysfunction related to twice-daily nebulized tobramycin inhalation solution (TIS). The patient was found to have a tobramycin serum level of 4.2 μg/mL 2.5 h after TIS dosing, with elevation remaining present at 1.1 μg/mL 24 h after discontinuation of therapy. Laboratory values at one month continued to show elevated creatinine levels at 2.1 mg/dL, suggesting progression of his baseline CKD. This case supports the benefit of obtaining tobramycin serum levels and vestibular/audiology function testing when evaluating patients on chronic nebulized TIS who present with acute or chronic renal dysfunction. From these serum levels, adjustments to daily dosing, regular monitoring of tobramycin serum levels, or discontinuation of treatment should be made to prevent permanent renal damage in patients with CKD. Calculated Naranjo ADR Probability Scale: 9; Definite. Full article

Adverse drug reactions (ADRs) are associated with morbidity, mortality, and can contribute to increased healthcare costs.This study was conducted to identify the occurence, types, and management of ADRs, as well as analyze the causal relationship, severity, and preventability of ADRs. The study was observational analysis with concurrent data collection from patients with Coronary Artery Disease-ST segment Elevation Myocardial Infarction (CAD-STEMI) treated in the Cardiac Intensive Care Unit (CICU) at a hospital in Bandung Indonesia, during the period of December 2013 to March 2014. The occurence of identified ADRs was assessed using the probability scale of Naranjo, while the severity by the scale of Hartwig and their preventability was evaluated using the scale of Schumock-Thornton. 49 ADRs were identified in 29 patients. Organ systems most affected by the ADRs were the cardiovascular and body electrolyte, each accounting for 20.41%. The hematology and gastrointestinal systems each contributed 18.37% to ADR occurrences. The causal relationship was mostly classified as “probable,” accounting for 69.39%. With regard to severity, most ADRs were classified as “moderate” at level 3, contributing to 53.06% of the occurence. In terms of preventability, most of the ADRs fell into the “non-preventable” category (79.59%). The most widely applied ADRs management was administration of an antidote or other treatments (40.82%). Further analysis revealed that the average number of drug types and duration of hospitalization significantly affected the presence of ADRs. Taken together, most patients with CAD STEMI treated in the CICU of the studied hospital experienced non-preventable ADRs and were treated with antidote or other treatments. Full article