Current drug safetyPub Date : 2024-01-01DOI: 10.2174/0115748863264472231227060926
Jairo Javier Jattin-Balcázar, Paula Andrea Quiroga-Ramírez
{"title":"Cardiac Toxicity in the Treatment of Light Chain Amyloidosis: Systematic Review of Clinical Studies.","authors":"Jairo Javier Jattin-Balcázar, Paula Andrea Quiroga-Ramírez","doi":"10.2174/0115748863264472231227060926","DOIUrl":"10.2174/0115748863264472231227060926","url":null,"abstract":"<p><strong>Background: </strong>Light chain amyloidosis (AL) is a progressive and a fatal disease that primarily affects cardiac tissue. Although the current approach to anti-amyloidosis treatments has managed to reduce amyloidosis morbimortality, the dynamics of cardiac adverse events are unknown.</p><p><strong>Objective: </strong>to provide evidence about reported cardiac toxicity during treatment of AL amyloidosis through a systematic review of the literature.</p><p><strong>Methods: </strong>A search was performed for registered clinical trials on ClinicalTrials.gov filtered for AL amyloidosis up to December 31, 2022. Studies were filtered by those that reported intervention in patients with AL amyloidosis and that had reported adverse events. The type of study, the intervention performed, and the frequency of reported cardiac adverse events were discriminated from each trial.</p><p><strong>Results: </strong>25 clinical trials were analyzed, representing a population of 1,542 patients, among whom 576 (38.95%) adverse events were reported, 326 being serious (SAE) and 242 nonserious (nSAE). The most frequent SAEs were cardiac failure, atrial fibrillation, and cardiac arrest, while the most frequent nSAEs were palpitations, atrial fibrillation, and sinus tachycardia.</p><p><strong>Conclusion: </strong>cardiac toxicity during treatment for amyloidosis seems common, and it is important to evaluate the relationship of therapies with its occurrence.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416583","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}
Current drug safetyPub Date : 2024-01-01DOI: 10.2174/1574886318666230529123200
Yunhua Xu, Yong Li, Jie Luo, Rong Tang
{"title":"Osimertinib-induced Keratitis and Secondary Toxic Epidermal Necrotic Drug Eruption- A Case Report and Literature Review.","authors":"Yunhua Xu, Yong Li, Jie Luo, Rong Tang","doi":"10.2174/1574886318666230529123200","DOIUrl":"10.2174/1574886318666230529123200","url":null,"abstract":"<p><strong>Background: </strong>Osimertinib is a third-generation Tyrosine Kinase inhibitor, mainly used in non-small cell lung cancer with EGFR mutation. Its efficacy and safety have been confirmed by clinical practice. Toxic epidermolysis necrotizing disease (TEN) is a severe drug eruption that is rare in clinics and has a high mortality rate. Toxic epidermal necrotic drug rash caused by Osimeritinib is even rarer.</p><p><strong>Objective: </strong>To investigate the rare side effects of Osimertinib through a case of toxic Epidermal necrosis.</p><p><strong>Case presentation: </strong>A 63-year-old female patient was diagnosed with lung adenocarcinoma with brain metastases, and genetic testing revealed an EGFR21 exon mutation. The disease progressed 24 days after the administration of gefitinib, then the patient switched to Osimertinib (80 mg QD) and, resulting in keratitis and secondary systemic toxic epidermolysis necrotizing disease (TEN). Finally, the patient died.</p><p><strong>Conclusion: </strong>Although the clinical use of osimertinib is becoming widespread, the side effects may not be fully understood. Clinicians should pay more attention to the occurrence of the side reaction and deal with it in time.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10680087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9902839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Current drug safetyPub Date : 2023-11-01DOI: 10.2174/157488631804230316165726
{"title":"Acknowledgement to Reviewers","authors":"","doi":"10.2174/157488631804230316165726","DOIUrl":"https://doi.org/10.2174/157488631804230316165726","url":null,"abstract":"","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136102923","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":"An Awareness of Pharmacovigilance among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy","authors":"Risani Andalasia Putri, Zullies Ikawati, Fita Rahmawati, Nanang Munif Yasin","doi":"10.2174/0115748863276456231016062628","DOIUrl":"https://doi.org/10.2174/0115748863276456231016062628","url":null,"abstract":"Background: Healthcare professionals play an essential role in reporting adverse drug reactions as part of pharmacovigilance activities. However, adverse drug reactions reported by healthcare professionals remain low. Objective: The aim of this systematic review was to investigate healthcare professionals' knowledge, awareness, attitude, and practice on pharmacovigilance and adverse drug reaction reporting, explore the causes of the underreporting issue, and provide improvement strategies. Methods: This systematic review was conducted using four electronic databases for original papers, including PubMed, Scopus, Google Scholar, and Scholar ID. Recent publications from 1st January 2012 to 31st December 2022 were selected. The following terms were used in the search: \"awareness\", \"knowledge\", \"adverse drug reaction\", \"pharmacovigilance\", \"healthcare professional\", and \"underreporting factor\". Articles were chosen, extracted, and reviewed by the two authors. Results: Twenty-five studies were selected for systematic review. This review found that 24.8%–73.33% of healthcare professionals were unaware of the National Pharmacovigilance Center. Around 20%–95.7% of healthcare professionals have a positive attitude toward pharmacovigilance and adverse drug reaction reporting, while 12%–60.8% of healthcare professionals have experience reporting any adverse drug reaction in their practice. The most frequently highlighted barriers to pharmacovigilance were a lack of awareness and knowledge regarding what, when, and to whom to report. Conclusion: Underreporting issues require immediate attention among healthcare professionals due to a lack of awareness and knowledge of pharmacovigilance and adverse drug reaction reporting. Educational and training program interventions have been suggested by most studies to address these issues.","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136181900","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}
Current drug safetyPub Date : 2023-04-27DOI: 10.2174/1574886317666220613163327
Namrata Chhabra, Anju George C
{"title":"A Case of <i>de novo</i> Annular-plaque Type Psoriasis Following Oxford- AstraZeneca COVID-19 Vaccination.","authors":"Namrata Chhabra, Anju George C","doi":"10.2174/1574886317666220613163327","DOIUrl":"https://doi.org/10.2174/1574886317666220613163327","url":null,"abstract":"<p><strong>Background: </strong>There have been increasing reported cases of new-onset or aggravation of pre-existing dermatoses after the implementation of COVID-19 vaccination.</p><p><strong>Case presentation: </strong>An elderly male was presented with multiple annular scaly plaques all over the body two weeks following administration of the first dose of Oxford-AstraZeneca COVID-19 vaccine. The lesions further aggravated after taking the second dose of the vaccine. The clinical and histopathology features were suggestive of annular plaque psoriasis.</p><p><strong>Conclusion: </strong>We report this first case of de novo plaque psoriasis following the Oxford- AstraZeneca COVID-19 vaccine, and it signifies a potential side effect of autoimmune reactivation after COVID vaccination.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9601677","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":"AChR+ Ocular Myasthenia and Facial Hemispasm: A Case Report of Unusual Association and Botulinum Toxic Type A Safety and Efficacy.","authors":"Stefano Zoccolella, Angelo Fabio Gigante, Salvatore Misceo","doi":"10.2174/1574886317666220908094404","DOIUrl":"https://doi.org/10.2174/1574886317666220908094404","url":null,"abstract":"<p><strong>Introduction: </strong>Hemifacial spasm represents segmental myoclonus of muscles innervated by the facial nerve, which is usually and successfully treated with botulinum toxin. Botulinum toxin (BTX) acts as an acetylcholine release inhibitor at presynaptic cholinergic junctions and therefore is considered contraindicated (or administrable with caution) in patients with neuromuscular disorders like Myasthenia Gravis (MG). Moreover, to date, the association of hemifacial spasm and ocular MG is extremely rare and only a few cases have been described.</p><p><strong>Case presentation: </strong>We report the case of a 73 years old man with a 3-year history of ocular MG who developed a left hemifacial spasm. The patient underwent hemispasm, treatment with BTX type A (abobotulinum toxin-A, total dose of 50 IU) that resulted in safe and successful 6 months re-evaluation.</p><p><strong>Conclusion: </strong>Our results suggest that in selected cases with concomitant MG and conditions characterized by orbicularis oculi spasms or hemispasm, BTX therapy may not be contraindicated and could be given at longer intervals due to prolonged effects.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9541542","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":"Docetaxel-induced Flagellate Erythema - Case Report and Brief Review.","authors":"Jerbi Asma, Kastalli Sarrah, Charfi Ons, Dhaghfous Riadh, El Aidli Sihem","doi":"10.2174/1574886317666220613155550","DOIUrl":"https://doi.org/10.2174/1574886317666220613155550","url":null,"abstract":"<p><strong>Introduction: </strong>Flagellate erythema is a distinctive morphologic reaction pattern recognized by whiplash-like pruritic erythematous eruption. It is usually encountered in patients receiving bleomycin. Only one case of docetaxel-induced flagellate erythema is reported in the literature.</p><p><strong>Case report: </strong>Herein, we report a rare case of docetaxel-induced flagellate erythema in a 53 years old woman with no particular medical history treated with docetaxel for metastatic adenocarcinoma of her right breast. Seven days after the third course, she developed multiple lineal and parallel pruritic erythematous streaks mainly on her chest and abdomen. The cutaneous erythema disappeared gradually over 10 days, leaving hyper-pigmented post-inflammatory linear scars lasting two weeks. The same reaction reappeared after the fourth and the fifth docetaxel course.</p><p><strong>Conclusion: </strong>Flagellate erythema has been reported as an adverse drug reaction secondary to several antineoplastic molecules, including docetaxel. Further studies are needed to discover its underlying mechanisms in order to figure out better treatment plans and prevention.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9547373","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}
Current drug safetyPub Date : 2023-01-01DOI: 10.2174/1574886317666220803104438
Dhanya Jose, Nitin Dhupdale, Jagadish A Cacodcar, Umesh Kamat
{"title":"Surveillance on Adverse Events Following COVISHIELD (ChAdOx1 nCoV-19) vaccination in Goa, India: An Observational Study.","authors":"Dhanya Jose, Nitin Dhupdale, Jagadish A Cacodcar, Umesh Kamat","doi":"10.2174/1574886317666220803104438","DOIUrl":"https://doi.org/10.2174/1574886317666220803104438","url":null,"abstract":"<p><strong>Background: </strong>COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination.</p><p><strong>Materials and methods: </strong>A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program.</p><p><strong>Results: </strong>Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours.</p><p><strong>Conclusion: </strong>Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca's ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford- AstraZeneca's ChAdOx1 vaccine in the UK-based population, which can be explained by preexisting immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9549529","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":"Depression Screening Scores and Allergy and Gastrointestinal Medication Use in Adolescents.","authors":"Kari Harris, Pavithra Saikumar, Yojana Sunkoj, Trista Vancuren, Blessing Olufowote, Julian DeDedeaux","doi":"10.2174/1574886317666220826170140","DOIUrl":"https://doi.org/10.2174/1574886317666220826170140","url":null,"abstract":"<p><strong>Introduction: </strong>Between 2005 and 2014, the 12-month prevalence of major depressive episodes among adolescents aged 12 to 17 years increased from 8.5% to 11.3%. Adolescent-onset depression is related to increased risk for depression and suicidal attempts in adulthood. It is known that depression is an adverse effect among adults taking OAM; however, the effect of OAM on adolescents is unknown.</p><p><strong>Aim: </strong>The aim of this study was to describe the relationship between Patient Health Questionnaire 9- Modified (PHQ9-M) scores and OAM use among adolescents.</p><p><strong>Methods: </strong>This study included data abstracted from charts of adolescents aged 12 to 21 years who completed a Kansas Be Healthy wellness appointment at the KUSM-W Peds Clinic in 2017. Odds ratios were used to calculate the relationship between oral allergy medication and gastrointestinal medication use among adolescents and PHQ9-M scores.</p><p><strong>Results: </strong>Of the 425 adolescent charts analyzed, 22% (n=96) had positive PHQ9-M screens (a score of 10 or greater), and 13% (n=56) reported current use of allergy medication and/or GI medications. Adolescents taking oral allergy medication were 1.77 times more likely to have a positive PHQ9-M screen than those not taking oral allergy medication. Among adolescents on allergy medication, there was no difference in PHQ9- M scores based on the drug class (1<sup>st</sup> or 2<up>nd</sup> generation antihistamine or Montelukast).</p><p><strong>Conclusion: </strong>Healthcare providers must diligently explore OAM/GI use with adolescents during clinical encounters and discuss possible adverse effects of OAM on mood.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9549543","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":"Current Cannabidiol Safety: A Review.","authors":"Chander Singh, Komal Rao, Nikita Yadav, Yogesh Vashist, Palak Chugh, Nidhi Bansal, Neha Minocha","doi":"10.2174/1574886317666220902100511","DOIUrl":"10.2174/1574886317666220902100511","url":null,"abstract":"<p><strong>Background: </strong>Marijuana, also known as cannabis, is the second most widely used illegal psychoactive substance smoked worldwide after tobacco, mainly due to the psychoactive effects induced by D-9-tetrahydrocannabinol (9-THC). Cannabidiol (CBD) is extracted from cannabis and may be used as an anti-inflammatory agent. Some patents on cannabidiol are discussed in this review. The cannabinoid is a non-psychoactive isomer of the more infamous tetrahydrocannabinol (THC); and is available in several administration modes, most known as CBD oil.</p><p><strong>Objectives: </strong>This study aims to provide an enhanced review of cannabidiol properties used in treating inflammation. This review also emphasises the current safety profile of cannabidiol.</p><p><strong>Methods: </strong>Cannabis is also called Marijuana. It is the second most commonly used illegal psychoactive substance in the universe after tobacco. D-9-tetrahydrocannabinol (9-THC) present in cannabis produces psychoactive effects. Cannabidiol (CBD) extracted from cannabis is used for antiinflammatory purposes. Cannabis smoking causes various types of cancer, such as lung, tongue, and jaw. The current review took literature from Google Scholar, PubMed, and Google Patents. Many clinical investigations are included in this review.</p><p><strong>Result: </strong>After analysing the literature on cannabis, it has been suggested that although cannabis is banned in some countries, it may be included in the treatment and mitigation of some diseases and symptoms like pain management, epilepsy, cancer, and anxiety disorder. Mild side effects were frequently observed in cannabis medications, which included infertility in females, liver damage, etc. Conclusion: Cannabis contains chemical compounds such as the cannabinoids delta-9- tetrahydrocannabinol (THC), a psychoactive substance, and non-psychoactive cannabidiol (CBD). Cannabidiol has been confirmed as an efficient treatment of epilepsy in several clinical trials, with one pure CBD product named Epidiolex. It is also used in treating anxiety and acne, as a pain reliever, and has anti-inflammatory properties.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9552965","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}