OBJECTIVE: Despite the importance of adverse drug reactions (ADRs), little is known about their role in perioperative neurosurgery. This study aimed to determine the prevalence of ADRs in perioperative neurosurgery and clarify the characteristics, severity, preventability, and risk factors of ADRs.
METHODS: Data for all patients who underwent neurosurgical procedures over an 11-year period were analyzed. During the study period, 3648 surgical procedures were performed for 2695 patients. Demographic and clinical information documented included medical history, allergic history, diagnosis, surgical method, suspected drugs, concomitant medications, and drug details. Multivariate logistic regression analyses were performed to identify independent parameters that were correlated with ADRs.
RESULTS: In total, 467 ADRs (18.3% ADRs/all neurosurgical procedures) were experienced by 401 patients. Anticonvulsants were associated with the highest number of ADRs (16.0%), followed by antibiotics (14.7%). Patients with ADRs were older than patients without ADRs (P<0.01). The total number of drugs in patients with ADRs was 8.8±3.6, compared to 5.2±2.4 for patients without ADRs (P<0.01). There were no significant differences in sex, allergic history, severe renal dysfunction (eGFR<30 ml/min/1.73 m2), hypertension, diabetes, urgency of surgery, and type of surgery. Multivariate analysis showed that a high total number of drugs (odds=3.2; 95%CI 1.9-5.1) and older age (odds=2.1; 95%CI 1.3-3.8) were independent risk factors for ADRs.
CONCLUSIONS: The frequency of suspected and severe ADRs was higher than expected. Polypharmacy and older age were independent risk factors for ADRs in perioperative neurosurgery. To decrease ADRs during perioperative neurosurgery, polypharmacy must be discouraged, especially among older adult patients.

Dyskinetic movements are characterized as hyperkinetic, repetitive movements of the extremities, facial, and oral musculature, most associated with prolonged dopamine D2 receptor blockade. In rare instances, dyskinetic movements can be brought on by selective serotonin reuptake inhibitor (SSRI) usage via an indirect D2 blockade mechanism, mimicking the D2 blockade observed with dopamine receptor blocking agents (DRBAs), such as in first-generation antipsychotics. This mimicked D2 blockade by SSRIs is said to be due to increased tonic inhibition by serotonin on dopaminergic neurons in the dopaminergic pathways of the brain, specifically the nigrostriatal pathway. In this case report, we look at a patient with a history of cerebral palsy who developed acute dyskinetic movements after short-term citalopram usage. The objective is to bring attention to the possible extrapyramidal side effects (EPS) of SSRI usage.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic presented a new challenge in modern medicine: the development of vaccines was followed by massive population vaccinations. A few reports on post-vaccination allergic reactions have made patients and medical personnel uneasy as to COVID-19 vaccines\' allergic potential. Most of the studies in this area to date have been small, and some that were based on global databases skipped most of the allergic diseases and concentrated only on anaphylaxis. We aimed to analyze the incidence of serious allergic reactions based on the EudraVigilance (EV) database, regardless of the reported symptoms and allergy mechanism.
METHODS: The total number of administrated vaccine doses was extracted on 5 October 2023 from Vaccine Tracker and included all administrations since vaccinations began in the European Economic Area (EEA). Data on serious allergic reactions to COVID-19 vaccines were extracted from the EudraVigilance database with the same time point. The code names of 147 allergic symptoms or diseases were used.
RESULTS: The frequency of serious allergic reactions per 100,000 administered vaccine doses was 1.53 for Comirnaty, 2.16 for Spikevax, 88.6 for Vaxzevria, 2.11 for Janssen, 7.9 for Novavax, 13.3 for VidPrevtyn Beta, and 3.1 for Valneva. The most prevalent reported reactions were edema (0.46) and anaphylaxis (0.40). Only 6% of these reactions were delayed hypersensitivity-oriented.
CONCLUSIONS: The overall frequency of potential serious allergic reactions to COVID-19 is very rare. Therefore, COVID-19 vaccines seem to be safe for human use. The lowest frequency of allergic reaction was observed for Comirnaty and the highest for Vaxzevria.

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Objectives: This study aimed to describe the prevalence and characteristics of ADRs and to identify the factors associated with ADRs among hospitalized patients. Methodology: A descriptive cross-sectional study was conducted over a 6 month period at Teaching Hospital Karapitiya (THK), Sri Lanka. A total of 2000 patients, who were admitted consecutively for any type of treatment during the study period were enrolled. The factors associated with ADRs were evaluated using logistic regression models, using ADR occurrence as the outcome. Results: A total of 123 ADRs were found from the sample. The prevalence of ADRs among hospitalized patients was 6.2%. (95% CI 5.1-7.2). ADRs were reported in 62 males (50.4%). The median (IQR) age of ADR occurrence was 52 (35-67) years. The most prevalent type of ADR was Type A (n = 62, 50.4%) and out of the total ADRs, 74 were moderately severe reactions (60.2%). Antibiotics (n = 29, 23.5%) were the most common causative agent for ADRs, followed by anticoagulants (n = 10, 8.1%). The multivariate logistic regression model showed that the number of prescribed drugs (P = .011), ADR history (P = 0 0.01) and diabetes mellitus (P = .003) were significantly associated with the occurrence of ADRs. Age (P = .21), gender (P = .31), ethnicity (P = .14), and other concomitant illnesses (Hypertension P = .66, Ischemic Heart Disease P = .25, etc.) did not associated with the occurrence of ADRs. Conclusion: According to this study the prevalence of ADRs was significant among inward patients in the Teaching Hospital, Karapitiya. The number of prescribed drugs, ADR history and diabetes mellitus were significantly correlated with the occurrence of ADRs. The results of the study can be used to guide healthcare professionals to revise the medication list frequently and monitor the patients who are at risk for developing ADRs.

UNASSIGNED: Antituberculosis drugs may cause mild, moderate or severe adverse drug reactions (ADR) leading to poor compliance. Description of the pattern of ADR and their related factors can help tuberculosis (TB) control program as part of the WHO programs. This study aims to investigate the incidence of ADR and associated factors among TB patients in northern Iran.
UNASSIGNED: This is a retrospective cohort study. The required information, including year of diagnosis, age, gender, residence area, nationality, HIV co-morbidity, history of anti TB treatment and ADR, was obtained from the Deputy of Health, Mazandaran University of Medical Sciences, Iran. All data were analyzed using SPSS version 21 software.
UNASSIGNED: Out of 3903 TB patients, 136 (3.5%) experienced major ADR. The incidence of ADR for men and women as well as for those with and without previous treatment history were 3.9% vs. 3.3% and 5.3% vs. 3.4%, respectively (p>0.05). Multiple logistic regression models showed a higher chance of ADR among those aged over 59 compared with those aged under 29 (OR=2.63, 95% confidence interval: 1.54-4.49).
UNASSIGNED: Age over 59 can be considered a risk factor for ADR with anti-TB drug administration.
UNASSIGNED: Antituberkulostatika (AT) können leichte, mittelschwere oder schwere unerwünschte Arzneimittelwirkungen (UAW) verursachen, die zu einer schlechten Compliance führen. Die Beschreibung des Musters von UAW und der damit zusammenhängenden Faktoren kann dem Tuberkulose(TB)-Kontrollprogramm helfen. Ziel der Studie ist es, die Häufigkeit von UAW und die damit zusammenhängenden Faktoren bei TB-Patienten im Norden des Irans zu untersuchen.
UNASSIGNED: Es handelt es sich um eine retrospektive Kohortenstudie. Die erforderlichen Informationen einschließlich Diagnosejahr, Alter, Geschlecht, Wohnort, Staatsangehörigkeit, HIV-Komorbidität, Vorgeschichte der TB-Behandlung und UAW, wurden vom stellvertretenden Gesundheitsamt der Mazandaran Universität für Medical Sciences, Iran, bereitgestellt und mit der Software SPSS Version 21 ausgewertet.
UNASSIGNED: Von 3903 TB-Patienten traten bei 136 (3,5%) schwerwiegende UAW auf. Die Häufigkeit von UAW bei Männern bzw. Frauen betrug bei vorheriger Behandlung 3,9% bzw. 3,3%, ohne vorherige Behandlung 5,3% bzw. 3,4% (p>0,05). Multiple logistische Regressionsmodelle ergaben, dass die Wahrscheinlichkeit einer UAW bei über 59-Jährigen höher war als bei unter 29-Jährigen (OR=2,63, 95 % Konfidenzintervall: 1,54–4,49).
UNASSIGNED: Ein Alter über 59 Jahren kann als Risikofaktor für UAW gegen Antituberkulostatika angesehen werden.

UNASSIGNED: The national pharmacovigilance (PV) system has been established in many countries worldwide following the thalidomide tragedy. Nurses have an important role in recognising and reporting any Adverse Drug Reaction (ADR); however, their role has not been widely explored, particularly in Southeast Asian countries.
UNASSIGNED: To assess the knowledge, attitudes and practice (KAP) about PV activities, along with barriers and facilitators that affect ADR reporting among hospital nurses in Malaysia. The present study also explores the relationship between demographic characteristics and predictors of KAP among hospital nurses in Malaysia.
UNASSIGNED: A multicentre, questionnaire-based, cross-sectional study was conducted in March-May 2021, among nurses working at tertiary care hospitals in Malaysia.
UNASSIGNED: The mean KAP score of study participants was 57 ± 11. Overall participants had poor ADR knowledge (37.4%), and poor reporting practices (48.9%). Age >30 years (AOR = 2.7 (1.13-6.8), p = 0.02), and working experience of greater than 10 years (AOR = 2.44 (1.08-5.52), p = 0.03), were significantly associated with good ADR knowledge and reporting practices among study participants.
UNASSIGNED: In summary, study findings offer valuable insight for developing targeted interventions and formal training to improve nurses\' ADR knowledge and reporting practices. Addressing gaps in these areas can enhance patient safety and overall healthcare quality.

Background: Phenytoin (PHT) has been approved for the treatment of epilepsy. It belongs to the category of medications with a limited therapeutic window and requires therapeutic drug monitoring (TDM). PTH has been observed to induce a variety of Adverse drug reactions (ADRs) including ataxia, dystonia, nystagmus, dyskinesia, etc. Phenytoin-induced ataxia is an uncommonly observed ADR of Phenytoin whose reports are extremely limited. Case: Herein, we present a case report of a 16-year-old Asian patient with a past history of epilepsy that was admitted to a tertiary care hospital due to the development of ataxia, giddiness, and vomiting when taking Phenytoin in addition to Oxcarbazepine, Clobazam, and Levetiracetam to treat seizures. On admission, Magnetic resonance imaging (MRI) findings revealed bilateral variable cerebrospinal fluid (CSF) lesions in the parieto-occipital region of the periventricular area (periventricular leukomalacia). Additionally, serum Phenytoin levels were observed to be in the toxic range (40 μg/mL) due to which physicians confirmed the ADR to be due to Phenytoin toxicity. Thus, the Phenytoin drug was discontinued in the patient gradually and he was continued on clobazam, oxcarbazepine, and brivaracetam which led to reversal of the ADR in the patient. Conclusion: In this case, ataxia resulted from Phenytoin overdose, as confirmed by MRI and serum tests suggesting that TDM of Phenytoin is essential to prevent ADRs. Given the scarcity of ataxia cases caused by Phenytoin, awareness is lacking within the scientific community. Our aim is to provide insights to promote better monitoring and patient-centered treatment outcomes for epileptic patients.

Due to the insufficiency of safety assessments of clinical trials for drugs, further assessments are required for post-marketed drugs. In addition to adverse drug reactions (ADRs) induced by one drug, drug-drug interaction (DDI)-induced ADR should also be investigated. The spontaneous reporting system (SRS) is a powerful tool for evaluating the safety of drugs continually. In this study, we propose a novel Bayesian method for detecting potential DDIs in a database collected by the SRS. By applying a power prior, the proposed method can borrow information from similar drugs for a drug assessed DDI to increase sensitivity of detection. The proposed method can also adjust the amount of the information borrowed by tuning the parameters in power prior. In the simulation study, we demonstrate the aforementioned increase in sensitivity. Depending on the scenarios, approximately 20 points of sensitivity of the proposed method increase from an existing method to a maximum. We also indicate the possibility of early detection of potential DDIs by the proposed method through analysis of the database shared by the Food and Drug Administration. In conclusion, the proposed method has a higher sensitivity and a novel criterion to detect potential DDIs early, provided similar drugs have similar observed-expected ratios to the drug under assessment.

Chemoimmunotherapy is an effective therapy for an individual with nonsmall-cell lung cancer (NSCLC) without anaplastic lymphoma kinase or epidermal growth factor receptor mutations. However, it can also be related to adverse cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with high morbidities and mortality rates. We present a case of a 65-year-old male with NSCLC who underwent first-line chemotherapy with paclitaxel, carboplatin, and pembrolizumab, which was later followed by a second cycle of the same therapies. The patient developed a fever and rash 12 days after the second cycle. Pembrolizumab was strongly suspected as the culprit medication because cutaneous reactions to this drug have been frequently reported and threw other medications used as less likely candidates. This is the first case reported in Vietnam of SJS/TEN related to pembrolizumab and contributes to our knowledge of severe skin reactions associated with immune checkpoint inhibitors.