Current drug safety最新文献

{"title":"Suicidal Thoughts and Self-injurious Behavior Associated With Glucagon- Like Peptide-1 Receptor Agonists - A Review.","authors":"Naina Mohamed Pakkir Maideen, Sulthan Al Rashid","doi":"10.2174/0115748863301925240507044637","DOIUrl":"10.2174/0115748863301925240507044637","url":null,"abstract":"<p><p>GLP-1 receptor agonists mimic the actions of GLP-1 and are used to manage type 2 diabetes and help with weight loss. In recent times, antidiabetic GLP-1 receptor agonists have been misused widely for weight loss. This review article focuses on some serious side effects of GLP-1 receptor agonists, notified by different regulatory agencies. We searched the literature in online databases such as Medline/Pubmed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of Science, Embase, and reference lists to identify publications relevant to the serious side effects associated with the use of GLP-1 receptor agonists. Various pharmacovigilance analyses and notifications from different regulatory agencies have documented the occurrence of suicidal thoughts and self-injurious behavior associated with the use of GLP-1 receptor agonists. Healthcare professionals should be aware of GLP-1 receptor agonistsassociated suicidal thoughts and self-injurious behavior. Patients should not misuse/abuse antidiabetic GLP-1 receptor agonists and should consult their physician before using any GLP-1 receptor agonists for weight loss.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"253-257"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mycophenolate Mofetil Induced-Colitis: Is it More about Clinical Diagnosis?","authors":"Yoghini Nagandran, Saikat Mandal, Ayuni Zahirah Zahar","doi":"10.2174/0115748863318109241104111738","DOIUrl":"10.2174/0115748863318109241104111738","url":null,"abstract":"<p><strong>Background: </strong>Mycophenolate mofetil (MMF) is an immunosuppressant commonly used for treating autoimmune diseases.</p><p><strong>Case presentation: </strong>We report a diagnostically challenging case of MMF-induced colitis in a patient after 3 years of initiation of MMF therapy. A 76-year-old Caucasian female with a history of chronic inflammatory demyelinating polyneuropathy receiving MMF presented to the hospital with a 7-weeks history of watery diarrhoea and crampy abdominal pains. Routine blood investigations, CMV-PCR, stool culture, viral PCR, Colonoscopy, and CT scan of the abdomen were broadly within normal limits. Histopathological changes were not significantly diagnostic apart from ischaemic-type changes. Finally, the reduction of the MMF dose caused the cessation of diarrhoea. Diagnosing MMF-induced colitis can be challenging, especially in patients on immunosuppressive medications. Further, long latency periods and non-specific colonoscopic and histopathologic changes add to the diagnostic dilemma.</p><p><strong>Conclusion: </strong>MMF-induced diarrhoea should be part of the clinician's differentials, and the decision to reduce the dose of MMF needs to be considered once infection and other causes have been ruled out.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"498-500"},"PeriodicalIF":0.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Presence of Nitrosamines and Nitrosamine Drug-Related Substances in Pharmaceutical Products: An Overview of Regulatory Concerns, Analytical Methodologies, and Control Strategies.","authors":"Neha Dhansekar, Pratiksha Rale, Yogesh Ghalsasi","doi":"10.2174/0115748863324951241028050225","DOIUrl":"10.2174/0115748863324951241028050225","url":null,"abstract":"<p><p>The presence of N-nitrosamine impurities in pharmaceutical products is well known. In 2019, it resulted in drug recall by the Food and Drug Administration (FDA). Soon, several groups identified the presence of many N-nitrosamines (NAs) in various Active Pharmaceutical Ingredients (APIs) and drug formulations worldwide. Moreover, in the last two years, another type of NAs was identified and detected in several pharmaceutical products. These are easily formed from the parent drug molecule and are known as Nitrosamine drug-related substances (NDSRIs). The amine group plays a major and unique role in the synthesis of many drug molecules, and hence, it is practically impossible to eliminate the presence of NAs and NDSRIs from drug products. The risk assessment of the health hazard to the patient was done, and the FDA has set the maximum daily acceptable intake (AI) at 18 ng/day for NAs. This limit poses a significant challenge in isolating, identifying and quantifying NAs and NDSRIs in APIs and formulations. For small, simple NAs, a lot of toxicological information and carcinogenetic data is available; however, for NDSRIs, such data is practically absent. This review article attempts to gather the toxicological data for a few NAs and NDSRIs and tries to assess the genotoxicity potential of some NDSRIs. The possible sources of NAs and NDSRIs, including synthetic methodology and processes, impurities associated with intermediates or raw materials, stability of the API, packaging materials, imprinting inks, and excipients, are also discussed. A summary of different analytical techniques used for the detection of these NAs and NDSRIs in different pharmaceutical products has also been included. Finally, various strategies employed for the minimization of these impurities along with additional control strategies to mitigate NAs and NDSRIs below acceptable limits, have also been discussed.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"404-414"},"PeriodicalIF":0.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Severe Case of Isotretinoin Induced Eosinophilic Pneumonia and Pericardial Effusion, a Case Report.","authors":"Anne Kampman, Laurien Keulers, Jan van der Maten, Jacqueline van der Meij, Carina Bethlehem","doi":"10.2174/0115748863274642231121072432","DOIUrl":"10.2174/0115748863274642231121072432","url":null,"abstract":"<p><strong>Background: </strong>We report a case of a 25-year-old female who presented with fever, rash and general malaise.</p><p><strong>Case presentation: </strong>She was initially diagnosed and treated for peri-/myocarditis, but she deteriorated quickly with the development of extensive bilateral consolidations for which she was mechanically ventilated. Two weeks before admission, she took isotretinoin for less than a week for disfiguring acne. Diagnosis of drug-induced acute eosinophilic pneumoniae (EP) was made after excluding other causes of AEP. Even before starting steroid treatment, the patient improved significantly, which was in alignment with the elimination of the active metabolite of isotretinoin.</p><p><strong>Conclusion: </strong>The presented case underlines the importance of performing a thorough history and consider recently started drugs as the cause of eosinophilic pneumoniae, even if they have not yet been described as a known trigger of drug-induced EP.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"74-77"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inhibitory Effects of Aspirin and Ibuprofen Overdose on Cholinesterase Activity: <i>In Vivo</i> and <i>In Vitro</i> Studies.","authors":"Parisa Saberi-Hasanabadi, Hesam Dezfulynejad, Hamidreza Mohammadi","doi":"10.2174/0115748863307031240805055529","DOIUrl":"10.2174/0115748863307031240805055529","url":null,"abstract":"<p><strong>Background: </strong>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 <i>in vivo</i> and <i>in vitro</i> effects of aspirin and ibuprofen injection on the activity of acetylcholinesterase and butyrylcholinesterase.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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 <i>in vitro</i> and <i>in vivo</i> analysis.</p><p><strong>Conclusion: </strong>The result of this study showed that non-steroidal anti-inflammatory drugs can inhibit the activity of the cholinesterase enzymes in both <i>in vivo</i> and <i>in vitro</i> conditions compared to the control group.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"323-328"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promoting Patient Engagement in Adverse Drug Reaction Reporting: A Novel Approach Utilizing Set Induction-Based Skill Questionnaires.","authors":"T Y Sree Sudha, Kusum Kumari, Hansraj Kumar, Monika Kankarwal, Ksbs Krishna Sasanka","doi":"10.2174/0115748863308469240819042052","DOIUrl":"10.2174/0115748863308469240819042052","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"329-333"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Carbamazepine-induced Stevens-Johnson Syndrome: A Case Report with Review of the Literature.","authors":"Arunkumar Subramanian, Rajamohamed Haitharali, S Nirenjen, T Tamilanban, Sivaraman Dhanasekaran, Sabariakilesh Gnanasekaran, Mohankumar Manavalan, Sangeetha Raja","doi":"10.2174/0115748863328893241018101435","DOIUrl":"10.2174/0115748863328893241018101435","url":null,"abstract":"<p><strong>Background: </strong>Stevens-Johnson Syndrome (SJS) is an infrequent yet severe mucocutaneous reaction that involves less than 10% of the Body Surface Area (BSA). It is predominantly induced by certain medications, including anticonvulsants (e.g., Lamotrigine, Carbamazepine, Phenytoin, Phenobarbitone), Allopurinol at doses above 100 mg per day, and sulphonamides (e.g., Cotrimoxazole, Sulfasalazine). Genetic predispositions, particularly the presence of the HLA-B*1502 allele, significantly increase the risk of developing SJS. This case report discusses a unique presentation of SJS in a young female patient, emphasizing the critical need for genetic screening and careful monitoring when prescribing Carbamazepine, especially in populations at higher genetic risk.</p><p><strong>Case presentation: </strong>A 19-year-old female patient, who had been on Phenytoin and Sodium Valproate for epilepsy management over the past year, was newly prescribed Carbamazepine. Within a week of initiating Carbamazepine, the patient experienced a seizure, followed by the sudden onset of fever, painful sores, and blisters covering the upper body, along with mucous discharge from both eyes. These symptoms rapidly worsened. Based on clinical presentations and the extent of epidermal detachment, the patient was diagnosed with SJS. The severity and mortality risks were assessed using the SCORTEN score. Therapeutic interventions included intravenous Ranitidine, Ondansetron, Paracetamol, Midazolam, Levetiracetam, and Dexamethasone, along with oral Fluconazole, Chlorpheniramine tablets, and Ciprofloxacin eye drops. The patient showed significant improvement and was discharged after fourteen days with followup advice.</p><p><strong>Conclusion: </strong>This case underscores the critical importance of performing genetic testing for the HLA-B*1502 allele and conducting baseline blood tests before initiating Carbamazepine therapy. Such precautionary measures can significantly mitigate the risk of severe adverse reactions like SJS. This report adds to the scientific literature by highlighting the potential dangers associated with anticonvulsant therapies and the necessity for personalized medicine approaches in preventing life-threatening conditions. The main takeaway is the pivotal role of genetic screening and vigilant monitoring in the management of patients requiring anticonvulsant medications to prevent serious adverse reactions.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"382-387"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diuretics-Induced Acute Pancreatitis: Case Series with a Review of the Literature.","authors":"Dhruvkumar M Patel, Maitri M Patel, Lalitkumar B Patel, Vahin B Patel, Mukundkumar V Patel, Dhara K Patel","doi":"10.2174/0115748863324787240916114833","DOIUrl":"10.2174/0115748863324787240916114833","url":null,"abstract":"<p><strong>Background: </strong>Although diuretic-induced Acute Pancreatitis (AP) cases are typically mild to moderate, severe and potentially fatal occurrences can arise. Case Series and Literature Review: We have, herein, presented a series of diuretic-induced AP cases from March 2018 to February 2024 of a 54-year-old woman treated with chlorthalidone, a 45-year-old male treated with hydrochlorothiazide, and a 48-year-old male treated with frusemide. The literature search has identified 26 cases published to date, 10 from frusemide and 16 from thiazide diuretics. The Naranjo adverse reaction probability scale has categorized all three drugs as \"probable\". All cases have responded to conservative treatment and cessation of the offending drug. Various mechanisms, such as hypersensitization, ischemia, direct cytotoxic effects, hypercalcemia, and dose-dependent idiosyncrasy, have been found to lead to intrapancreatic activation of pancreatic enzymes, resulting in drug-induced AP.</p><p><strong>Conclusion: </strong>Further research into the mechanisms and genetic factors contributing to diureticinduced AP is essential for enabling early diagnosis and management of diuretic-induced AP.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"509-513"},"PeriodicalIF":0.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Parsonage-Turner Syndrome Following AstraZeneca COVID-19 Vaccination.","authors":"Maroua Slouma, Malek Dhifallah, Lobna Ben Ammar, Imen Gharsallah","doi":"10.2174/0115748863322806240808095118","DOIUrl":"10.2174/0115748863322806240808095118","url":null,"abstract":"<p><strong>Introduction: </strong>Parsonage-Turner Syndrome is an uncommon cause of shoulder pain.</p><p><strong>Case representation: </strong>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.</p><p><strong>Conclusion: </strong>A better knowledge of this disease and early recognition are crucial to prevent unnecessary tests and interventions.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"526-531"},"PeriodicalIF":0.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Facial Hyperpigmentation Following Adalimumab.","authors":"Mahjoubi Yasmine Salem, Aouinti Imen, Dahmani Israa, Zgolli Fatma, Charfi Ons, El Aidli Sihem","doi":"10.2174/0115748863357040241025051122","DOIUrl":"10.2174/0115748863357040241025051122","url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor alpha (TNF-α) inhibitors, such as adalimumab, have significantly advanced the treatment of inflammatory diseases. However, these therapies are associated with various cutaneous adverse reactions.</p><p><strong>Case presentation: </strong>We describe two rare instances of isolated facial hyperpigmentation induced by adalimumab. Both patients presented with asymptomatic, isolated brown macules on the cheeks following adalimumab treatment for ankylosing spondylitis. The hyperpigmentation appeared shortly after starting the medication in both cases. In one case, the hyperpigmentation persisted despite stopping the medication, while in the second case, it completely resolved within one month after discontinuation. However, in the second patient, the hyperpigmentation recurred after switching to certolizumab, another TNF-α inhibitor. No skin biopsies were performed, and both patients were otherwise healthy, with normal laboratory evaluations.</p><p><strong>Conclusion: </strong>Hyperpigmentation is an uncommon adverse reaction of this class of drugs, with only a few reported cases in the literature. The recurrence of hyperpigmentation after switching to another TNF-α agent, certolizumab, further suggests that this reaction may be a class effect, adding new insights into the spectrum of cutaneous side effects associated with TNF-α inhibitors. Clinicians should consider this potential side effect in patients presenting with hyperpigmentation, and sun protection should be recommended as a preventive measure.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"504-508"},"PeriodicalIF":0.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}