Current drug safety最新文献

Introduction: Parsonage-Turner Syndrome is an uncommon cause of shoulder pain.

Case representation: Herein, we present the case of a male in his 40s, who was presented with a 3-month history of acute onset of intense shoulder pain, which decreased rapidly leaving behind a residual upper limb weakness. The diagnosis of Parsonage-Turner Syndrome following COVID-19 vaccination was made based on electroneuromyography and magnetic resonance imaging findings. The patient responded well to analgesics and rehabilitation.

Conclusion: A better knowledge of this disease and early recognition are crucial to prevent unnecessary tests and interventions.

Background: Acute Pancreatitis (AP) is an uncommon complication that rarely occurs during Rheumatoid Arthritis (RA). Among the varied etiologies of AP, Drug-induced Pancreatitis (DIP) remains a rare entity and a rather challenging condition. A large panel of drugs have been reported to cause pancreatitis; however, there are no cases of tofacitinib-induced pancreatitis reported in the literature.

Case presentation: We have, herein, reported the case of a Tunisian 58-year-old woman with a four-year history of RA who experienced two episodes of AP; the first one occurred on the second day of a 3-day series of methylprednisolone intravenous injections, and the second episode occurred on the sixth-day of tofacitinib administration. Each time, she presented acute abdominal pain with characteristic radiation to the back. Symptoms resolved spontaneously once the suspected drug was discontinued. In the event of a negative investigation, including abdominal ultrasonography and magnetic resonance imaging, and assessment of albumin, calcemia, triglyceridemia, serum ferritin, and IgG4 levels, DIP was the most likely diagnosis.

Conclusion: Although DIP is still a rare condition, it remains serious with an increased risk of mortality. We intended to alert clinicians that in addition to the known side effects of tofacitinib, pancreatitis may be induced by this drug, especially in predisposed patients.

Paxlovid (nirmatrelvir/ritonavir) is the first oral therapy approved by the US FDA to treat patients with mild-to-moderate COVID-19. Our current review focuses on clinical data related to tacrolimus toxicity induced by Paxlovid currently available. A number of online databases, including LitCovid, Scopus, Web of Science, Embase, EBSCO host, Google Scholar, Science Direct, and the reference lists were searched to identify articles related to Paxlovid-induced tacrolimus toxicity, using keywords, like drug interactions, Paxlovid, ritonavir, nirmatrelvir, tacrolimus, pharmacokinetic interactions, and CYP3A. Tacrolimus is a substrate of CYP3A enzymes and ritonavir of Paxlovid has been identified as a potent inhibitor of CYP3A enzymes. Hence, Paxlovid can inhibit the CYP3A-mediated metabolism of tacrolimus, resulting in elevated plasma concentrations of tacrolimus and toxicity. A number of case reports and case series have been published to highlight the association of Paxlovid and tacrolimus toxicity in transplant recipients with COVID-19 infection. Various recommendations have been proposed to prevent and mitigate the adverse events related to the DDI of Paxlovid and tacrolimus. Transplant physicians should be aware of this DDI and collaborate with clinical pharmacists on this issue.

Background: Ciprofloxacin is a fluoroquinolone antibiotic widely used in clinical practice with a fluorine atom in its chemical structure. Like other antibiotics, it can induce several adverse effects, such as tendinopathy, musculoskeletal toxicity, peripheral neuropathy, and cardiotoxicity, thereby causing relevant and irreversible health injuries. Ciprofloxacin fluoride's adverse toxicological effect associated with a urinary fluoride concentration above the reference value has not yet been reported.

Objective: This case report aimed to provide evidence of ciprofloxacin treatment intoxication, an antibiotic containing a fluorine atom in its chemical structure, associated with a fluoride urine concentration above the reference value.

Case presentation: A 32-year-old man developed tendinopathy and peripheral neuropathy on the third day's night after initiating the ciprofloxacin doses, exhibiting symptoms comparable to a low-power electrical discharge and very intense motor agitation. After following habitual laboratory exams, a urinary fluoride measurement was performed by an ion-selective electrode. The urinary fluoride concentration was above the reference values in mg/g of creatinine.

Conclusion: This is the first study that has described an association among ciprofloxacinfluoride, tendinopathies, and peripheral neuropathy. The patient's symptomatology has suggested a toxic effect related to fluoride. We consider the documented finding of a fluorine atom at the ciprofloxacin structure and its toxic potential neuropathies and tendinopathies as an issue of alert.

This extensive review delves into the complex relationship between prolonged use of metformin and the possible emergence of vitamin B12 deficiency (VB12D) in diabetic patients. Metformin, a pivotal element in diabetes management, is constantly linked with decreased absorption of vitamin B12, prompting concerns about the enduring consequences of this interaction. The review systematically amalgamates current evidence, elucidating the prevalence, mechanisms, and clinical ramifications of VB12D induced by consistent consumption of metformin. Exploring the different pathways through which metformin might disrupt the absorption of Vitamin B12, the review encompasses interference with the calcium-dependent membrane activity and alterations of the microbiota present in the gut. A meticulous analysis of experimental studies and human trials is undertaken, accentuating the prevalence of variable VB12D among individuals on long-duration treatment of metformin across diverse populations and age groups. Clinical indications of cobalamin deficiency, spanning haematological abnormalities to neurological complications, are systematically examined. Furthermore, the review delves into the potential implications of cobalamin deficiency associated with metformin on diabetes-related complications and overall patient health. This review offers a comprehensive overview of the intricate interplay between the use of metformin and deficiency of vitamin B12 in diabetic patients, emphasizing the importance that lies in routine monitoring, early detection, and personalized interventions to optimize the long-period safety and efficiency of metformin in the treatment of diabetes. It also proposes future research directions to refine clinical guidelines and enhance the understanding regarding the correlation between diabetes, metformin, and vitamin B12.

Background: Infections with Soil-transmitted Helminths (STHs) impact about 24% of the global population. A disproportionate number of individuals, particularly those from low socioeconomic backgrounds, live in emerging nations. In India, between the ages of one and fourteen, almost 220 million children are susceptible to intestinal worm infestations caused by parasites. The National Deworming Day (NDD) initiative was started by the Indian government in February 2015 as a part of the National Health Mission to address this problem. Though the adverse effects of albendazole in routine therapy are known, the mass administration of the medicine in children as part of a public health program has not been adequately studied.

Objective: This study aimed to determine the occurrence, type, and severity of adverse drug reactions resulting from mass administration of albendazole in school children aged 6-19 years in a district of northern India.

Methods: Twenty specified clusters were randomly chosen from a total of 96 clusters in the district to participate in this prospective, descriptive, observational study that was carried out in Karnal, Haryana. Both a passive approach and an active adverse drug reaction reporting system were used in the study. The six-step process known as Deb’s Active Surveillance & Assisted Reporting System was employed in our study. Adverse drug reactions were recorded using the suspected Adverse Drug Reaction (ADR) reporting form of the Pharmacovigilance Programme of India (PvPI).

Results: Twenty clusters with a combined total of 94 schools and 12,751 students were observed during the study. In this study, there were more female participants (N = 8,060; 63.21%) than male participants (N = 4,691; 36.78%). A total of 29 ADRs were reported. All reported ADRs were mild in nature. It was discovered that there were 1.37 incidences for every 1000 individuals. As illustrated in Fig. (1), the most frequently reported Adverse Drug Reactions (ADRs) were vomiting (N = 10), nausea (N = 4), abdominal pain (N = 2), and headache (N = 1). The majority of ADRs were categorized as probable (N=18; 62.06%), followed by possible (N=11; 37.93%).

Conclusion: An active surveillance system alongside voluntary passive reporting during the mass administration of medicines can help evaluate the safety profile of the medicinal products. The occurrence of ADRs following mass administration of albendazole in school children was found to be only 1.37 incidences for every 1000 recipients, being mild in nature, with vomiting being the most common.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Background: In recent years, it has been reported that long-term use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may have protective effects against neurodegenerative diseases by inhibiting the activity of cholinesterase enzymes. The exact biological mechanism of these protective effects is not yet known. This study aims to assess the in vivo and in vitro effects of aspirin and ibuprofen injection on the activity of acetylcholinesterase and butyrylcholinesterase.

Materials and methods: In this experimental study, 70 adult male mice (20-25 g) were divided randomly into 7 groups (n= 10) including a control group that received normal saline and other groups that received different dosages of aspirin and ibuprofen (100, 200, and 300 mg/kg) in the form of intraperitoneal injection. Mice were anesthetized by ether, and blood samples were taken from the heart. Ellman´s methods were used to measure cholinesterase, erythrocytes, and serum, respectively.

Results: The activity of cholinesterase enzymes in serum and erythrocytes decreased significantly (P<0.0001) in treated groups with aspirin and ibuprofen compared to the control samples after 3 and 24 hours. However, these inhibitory effects were variable depending on the dose of the injected drugs, and they were statistically significant at higher injection doses in vitro and in vivo analysis.

Conclusion: The result of this study showed that non-steroidal anti-inflammatory drugs can inhibit the activity of the cholinesterase enzymes in both in vivo and in vitro conditions compared to the control group.

Introduction: Methimazole is an antithyroid drug known to cause hematological toxicity, including agranulocytosis and, very rarely, pancytopenia. We herein present a case of a patient with Graves' Disease (GD) who developed methimazole-induced pancytopenia.

Case report: A 53-year-old Peruvian woman with GD, initially treated with methimazole 20 mg BID, experienced odynophagia, fever, and malaise after 37 days of treatment. The initial diagnosis was agranulocytosis, leading to the discontinuation of methimazole and initiation of antibiotics. Due to persistent neutropenia, a Granulocyte Colony-stimulating Factor (G-CSF) was administered. Eight days later, she developed pancytopenia and was managed with hematopoietic agents and platelet transfusions. The patient recovered with normalization of the blood count, eliminating the need for Bone Marrow (BM) examination. Radioiodine therapy was chosen as the definitive treatment, resulting in hypothyroidism. Currently, the patient is thyroidal and hematologically stable.

Conclusion: Methimazole-induced pancytopenia is a rare and serious complication; however, with appropriate treatment, complete recovery can be achieved.