OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.

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UNASSIGNED: Migraine,a prevalent neurovascular disorder,can significantly disrupt an individual\'s daily life.Atogepant (AGN-241689),an orally administered small molecule drug classified as a calcitonin gene-related peptide receptor antagonist,is utilized for prophylactic migraine treatment.The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.
UNASSIGNED: Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023.Disproportionality analysis was employed to quantify relevant AEs associated with atogepant.Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data.This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA).Results:From the FAERS database,a collection of 7,991,243 reports was obtained.Among these reports,a subset of 3015 were identified as \'primary suspected (PS)\' AEs specifically related to atogepant.AEs induced by atogepant were observed across 27 organ systems.A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified.
UNASSIGNED: Our study has identified adverse events (AEs) associated with atogepant,potentially providing crucial support for the clinical monitoring and risk identification of atogepant.

Prior research has indicated that bisphosphonates (BPs) can improve periodontal disease because of their anti-osteoporosis properties. In vitro studies have shown that BPs induce cytotoxicity, inhibit wound healing, and thus affect periodontal disease. Denosumab and BPs have alternative indications. BP and denosumab are not known to correlate with gingival disorders. We assessed such a relationship by applying Bayesian and nonproportional analyses to data in the US FDA Adverse Event Reporting System (FAERS) database. The study analyzed BPs and denosumab-reported incidents with preferred terms found in the narrow Standardized MedDRA Queries for gingival disorders. A total of 5863 reported cases of gingival disorders were associated with five BPs (alendronate, pamidronate, ibandronate, risedronate, and zoledronate) and denosumab. More than 15% of patients with gingival disorders related to BPs and denosumab other than denosumab were hospitalized over short- or long-term periods. Our findings indicated BPs and denosumab had significant reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) with respect to gingival disorders. Pamidronate had the highest association (ROR = 64.58, PRR = 57.99, IC = 5.71), while the weakest association was found with denosumab (ROR = 3.61, PRR = 3.60, IC = 1.77). Significant associations were found between the six drugs and gingival pain, gingival recession, gingivitis, periodontal disease, and periodontitis. In conclusion, our comprehensive overview of the correlations, clinical characteristics, and prognoses of BPs and denosumab-related gingival disorders suggests that these issues deserve continued surveillance and appropriate management.

BACKGROUND: Despite treatment modalities for multiple myeloma can cause adverse drug reactions (ADRs), data are scarce about the types, severity and preventability of chemotherapy-related ADRs in Kenya. This study aimed to assess the chemotherapy-related ADRs among multiple myeloma patients at Kenyatta National Hospital (KNH).
METHODS: A one-arm retrospective cohort study was carried out among all eligible adult patients with a documented diagnosis of multiple myeloma between 1st January 2017 to 31st December 2023. A data abstraction tool was used to assess sociodemographics, clinical characteristics and chemotherapy-related ADRs. The Schumock and Thornton scale and the modified Hartwig and Siegel severity scale were employed to evaluate the preventability and severity of ADRs, respectively. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 29.0 software. The results were presented using mean, frequency and percentage. Binary logistic regression was employed to assess factors influencing ADRs. A p-value of less than 0.05 was considered statistically significant.
RESULTS: The prevalence of ADRs in this study was 81.5% with a total of 230 ADRs identified. The primary ADRs identified were peripheral neuropathy (21.7%), nausea and vomiting (14.8%), neutropenia (12.2%) and anemia (11.3%). The majority of the ADRs (51.7%) were moderate in severity, and 29.8% were of mild severity. Preventability assessments of the ADRs showed that most of them (68.2%) were definitely preventable and 13.2% were probably preventable. VRD (Bortezomib/Lenalidomide/Dexamethasone) and VCD (Bortezomib/Cyclophosphamide/Dexamethasone) treatment regimens were responsible for most of the ADRs. VRD (AOR = 11.1, 95% CI = 3.7-32.8, p < 0.001) and VCD treatment regimens (AOR = 4.8, 95% CI = 1.1-20.0, p = 0.033) were the significant factors affecting the occurrence of ADRs.
CONCLUSIONS: Overall, the incidence of chemotherapy-related ADRs in multiple myeloma patients at KNH was notably high (81.5%). Despite the moderate severity of the ADRs, their preventable nature highlights the potential for improved patient outcomes through careful regimen selection and monitoring.

BACKGROUND: Existing literature has questioned the sensitivity of patch testing (PT) with cotrimoxazole (CTX) in the study of drug hypersensitivity.
OBJECTIVE: Assess the sensitivity of PT with CTX in non-immediate cutaneous adverse drug reactions (CADR).
METHODS: Retrospective analysis (2000-2022) of PT with an antibiotic series including CTX 10% pet (Chemotechnique Diagnostics©) performed according to ESCD guidelines in patients with suspected non-immediate CADR reactions to CTX. Some patients were additionally tested with in-house preparations of CTX from Bactrim DS® tablets at 10% in pet or water and trimethoprim 10% pet (Laboratórios Edol©).
RESULTS: Sixty-four patients (48F/16M; mean age 47 ± 18) were included, mostly with maculopapular exanthema (51, 80%). Notably, CTX was sole suspect in 24 patients. There was no positive reaction to CTX at 10% from Chemotechnique or Bactrim DS® tablets prepared at 10% pet for patch testing. One patient reacted exclusively to trimethoprim with 1+ reaction. Two patients had a faint reaction (1+) only with the powder of Bactrim DS® tablets in water at D2, but as the reactions faded completely in 24 or 48 h, they were interpreted as irritant non-specific reactions.
CONCLUSIONS: These findings suggest that patch testing may lack sufficient sensitivity to diagnose CTX-induced non-immediate CADR. Therefore, clinicians should be cautious interpreting CTX patch test results.

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UNASSIGNED: Pharmacovigilance (PV) plays a central role as a quality benchmark for healthcare systems in any country. Adverse drug reactions (ADRs) contribute significantly to patient hospitalization and are major contributors to morbidity and mortality worldwide. Achieving improvements in health infrastructure and employing precise monitoring tools are essential components of drug safety. As reliance on drug therapy increases, patient exposure to potential risks rises, emphasizing the importance of minimizing ADRs.
UNASSIGNED: A search for studies published from January 2010 to November 2023 was retrieved from PubMed, Medline, and Google Scholar databases. We developed the search strategies using the Mesh terms and keywords. Only English-language literature was included.
UNASSIGNED: Twenty-nine studies met the inclusion criteria and utilized to evaluate the pharmacovigilance and its outcomes. The Saudi 2030 vision outlines an initiative to enhance patient care through a robust, safety- and quality-centered culture, fostering collaboration between drug manufacturers and regulatory authorities. This collaborative approach is expected to result in higher-quality care for the public. Moreover, a unified, simple, and advanced ADR reporting portal, in collaboration with stakeholders, is recommended to enhance the quality of ADR reporting. Also, commitment to training, updating courses, and incorporating PV practices into curricula demonstrates progress in Saudi PV System.

OBJECTIVE: Chagas disease (ChD) affects approximately 7 million people in Latin America, with benznidazole being the most commonly used treatment.
METHODS: Data from a retrospective cohort study in Argentina, covering January 1980 to July 2019, was reanalysed to identify and characterize benznidazole-related adverse drug reactions (ADRs).
RESULTS: The study included 518 patients: 449 children and 69 adults (median age in children: 4 years; adults: 25 years; age ranges: 1 month-17.75 years and 18-59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days in adults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs, with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults (odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19-0.54, P < .001). The incidence rate was 177 cases per 1000 person-years (95% CI = 145-214) in children and 537 per 1000 person-years (95% CI = 360-771) in adults. There were 240 ADRs identified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) of children and 1.45% (1/69) of adults. The skin was the most affected system. A total of 10.23% (53/518) of patients discontinued treatment. More adults than children discontinued treatment (OR = 3.36, 95% CI = 1.7-6.4, P < .001).
CONCLUSIONS: Although 29.34% of patients experienced ADRs, most were mild to moderate, indicating a manageable safety profile for benznidazole. While optimized dosing schedules and new drugs are needed, avoiding benznidazole solely due to safety concerns is not justified.

Background Self-medication (SM), a common practice globally, possesses a dual challenge of being a self-care strategy and a potential source of harm observed across all age groups. The study is being conducted to gauge the prevalence of SM of prescription drugs with their over-the-counter access, thus addressing the delicate balance between self-care and self-harm related to SM. Material and methods This ongoing convergent parallel mixed method study with quantitative and qualitative components will be conducted on a sample size of 180 subjects aged more than 18 years from an urban community. For the quantitative component, a semi-structured questionnaire will assess the prevalence of SM, types of medications used, reasons for self-medicating, and socio-demographic factors influencing these practices. Concurrently, qualitative interviews delve deeper into the beliefs shaping SM practices. Sampling will be purposive to capture diverse perspectives, with data analyzed using statistical tools. Results This study protocol will offer a comprehensive understanding of the prevalence and determinants of SM practices. The quantitative data provide numerical insights into SM trends, while the qualitative findings elucidate the nuanced factors driving individuals\' SM choices. Conclusions A multifaceted view of SM practices will be provided, aiding in developing interventions to promote safe and effective self-care while mitigating the risks of self-harm through SM. Anticipated findings can include a widespread prevalence of SM amongst the general urban populace. Significant associations can also be expected to be found with various independent variables. The results will be instrumental in informing public health policies and healthcare practices toward enhancing patient safety and well-being.

Opioids are the strongest analgesics available and are crucial in the treatment of acute and chronic pain. The line between these critical medications and how they are used beyond standard therapeutics in cases such as abuse, misuse, and medication errors needs to be understood, as it affects their safety, efficacy, and manner of use. The aim of this systematic review was to identify what is known about the adverse events resulting from the abuse, misuse, and medication errors associated with opioid use. A systematic search was conducted in the PubMed®, Scopus® and, EBSCO® databases to retrieve studies from the inception to December 2023 reporting abuse, misuse, and medication errors associated with medicinal opioid use. Two authors independently screened titles and abstracts and full text according to eligibility using Covidence® software. Full articles were examined by two independent reviewers, and disagreements were resolved by a third reviewer. The risk of bias was assessed by the JBI\'s critical appraisal tools. A total of 934 articles were screened by their title and abstract. Then, 151 articles were selected for full text screening. Of these, 34 studies were eligible for inclusion in this review. The included studies varied significantly in their population sizes, ranging from 9 individuals to 298,433 patients, and encompassed a diverse demographic, including all ages and both sexes. The studies consistently reported a range of adverse events associated with opioid use. Fentanyl, morphine, oxycodone, tramadol, and hydrocodone were frequently implicated. The data heterogeneity in this field resulted in challenges in drawing conclusions. The review highlights that some opioids, particularly fentanyl, morphine, and oxycodone, are frequently associated with preventable adverse drug reactions, abuse, and medication errors, underscoring the need for robust preventative measures and ongoing research to mitigate opioid-related harm.