Current drug safety最新文献

{"title":"Role and Responsibilities of Various Stakeholders in Pharmacovigilance.","authors":"Pinki Phougat, Meenu Beniwal, Garima Kapoor, Navidha Aggarwal, Aanchal Kumari, Rashmi Sharma, Hitesh Chopra, Rohit Sharma, Mohammad Amjad Kamal","doi":"10.2174/0115748863277574240125045459","DOIUrl":"10.2174/0115748863277574240125045459","url":null,"abstract":"<p><p>In this review paper, we have analyzed the potential and issues associated with Pharmacovigilance (PV). The analysis is divided into four sections: background, stakeholders, data sources, and medicinal chemistry. Each section discusses the current state, the future trends, and the best practices of PV. The main purpose, methods, results, and implications of our analysis are summarized.</p><p><strong>Background: </strong>PV is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions. PV was established by the World Health Organization in response to the thalidomide tragedy of 1961. The main purpose of PV is to ensure the safety and efficacy of drugs in clinical practice. Stakeholders: PV involves various stakeholders, such as patients, pharmacists, pharmaceutical companies, healthcare professionals, and regulatory authorities. Each stakeholder has a different role and responsibility in reporting, processing, analyzing, and communicating information about adverse drug reactions. Patient engagement is a key factor for enhancing PV practices.</p><p><strong>Data sources: </strong>PV relies on data from various sources, such as clinical trials, spontaneous reports, electronic medical records, biomedical literature, and patient-reported data in online health forums. These data sources can provide valuable insights into the real-world use and safety of drugs, as well as the preferences and needs of patients. However, these data sources also pose challenges in terms of quality, validity, reliability, and accessibility. Medicinal Chemistry: Medicinal chemistry is the branch of chemistry that deals with the design, synthesis, and evaluation of new drugs and their biological effects. Medicinal chemistry can enhance PV practices by finding new therapeutic indications for existing drugs or compounds that have already been tested for safety and efficacy. Medicinal chemistry also requires careful design and evaluation of covalent inhibitors, bi-substrate inhibitors, stabilizers of protein non-effective conformations, and hydrophobic pocket modifiers to ensure their safety and efficacy.</p><p><strong>Implications: </strong>PV is a dynamic and evolving discipline that requires collaboration, regulation, education, and innovation to improve patient safety and care. This review aims to provide a comprehensive overview of the potential and issues associated with PV practices.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"19-32"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691438","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":"https://doi.org/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":""},"PeriodicalIF":1.1,"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 Systematic Review of the COVID Vaccine's Impact on the Nervous System.","authors":"Viswarupachari Tanguturi Yella, Sumit Pareek, Bhumika Meena, K S B S Krishna Sasanka, Pugazhenthan Thangaraju, Sree Sudha T Y","doi":"10.2174/0115748863273931231121072231","DOIUrl":"10.2174/0115748863273931231121072231","url":null,"abstract":"<p><strong>Aims & objectives: </strong>The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications.</p><p><strong>Method: </strong>We performed a comprehensive search of the literature using Google Scholar, PubMed, and NCBI databases from December 2021 to December 2022. For Google Scholar, PubMed, and NCBI databases we used the following key search terms: \"neurological adverse effects\", \"COVID-19 vaccination\", \"SARS-CoV-2\", CNS complications, and CNS adverse effects. Two reviewer authors individually searched and assessed the titles and abstracts of all articles. The third reviewer resolved the disagreement between them. Data were documented regarding title, study location, type of study, type of COVID-19 vaccine, type of neurological complications/ adverse effects, and sample size.</p><p><strong>Results: </strong>From our findings, it is confirmed that these neurological complications like Guillain- Barre syndrome (23.6%), Neuromyelitis Optica spectrum disorder (5.5%), Neuropathy (6.9%), Transverse Myelitis (8.3%) and Acute disseminated Encephalomyelitis (4.1%) are majorly affected in most of the people. The increase in risks associated with SARS-CoV-2 infection far outweighs any previously reported associations with vaccination.</p><p><strong>Conclusion: </strong>We found no safety signal was observed between COVID-19 vaccines and the immune- mediated neurological events. Before assuming a causal relationship, the side effects of the COVID-19 vaccine should first be carefully examined to rule out known associated factors. Symptom onset was within two weeks of vaccination in the majority of cases; as such, this seems to be a high-risk period warranting vigilance.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"33-47"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563860","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":"Persistent Hiccups Shortly after Tramadol Intake: A Case Report and Literature Review.","authors":"Hossam Tharwat Ali, Ziad Emad Mohamed, Mohamed Mahmoud Shalaby, Ana Leticia Fornari Caprara, Jamir Pitton Rissardo","doi":"10.2174/0115748863290330240116094015","DOIUrl":"10.2174/0115748863290330240116094015","url":null,"abstract":"<p><strong>Background and objective: </strong>Tramadol can inhibit serotonin and norepinephrine reuptake leading to stimulation of the central component of the hiccup reflex arc. We have found only two previous cases of tramadol-induced hiccups. Additionally, three pharmacovigilance studies have investigated the involvement of tramadol in cases who have developed hiccups as adverse effects. Herein, we have presented a case of a middle-aged male who has developed hiccups shortly after tramadol intake.</p><p><strong>Case presentation: </strong>A 35-year-old male complaining of chronic pain in the right knee was treated with tramadol. The individual developed hiccups within 10 hours of the first tramadol dose. The patient tried to stop the hiccups with non-pharmacological measures, such as stopping the air inside the lungs and drinking cold fluids. The patient appeared to concentrate on avoiding hiccups, which he could avoid for some time. However, then, the hiccups would come all at a unique time. The hiccups occurred at a frequency of one hiccup/5-10 seconds, interrupting the patient's nutrition and sleep pattern. Eventually, tramadol was suspected of inducing hiccups, and baclofen was started.</p><p><strong>Conclusion: </strong>Tramadol as well as opioids should be considered as a cause of hiccups. We aim to improve awareness about the safety of such drugs among physicians and the proper management of associated risks.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":"78-83"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650429","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":"Vorasidenib: A Milestone in Targeted Therapy for IDH-Mutant Lower Grade Gliomas - Efficacy, Emerging Safety Concerns, and the Call for Comprehensive Safety Evaluation.","authors":"Beema T Yoosuf, Manisa Pattanayak, Sanjit Sah","doi":"10.2174/0115748863355533241202110934","DOIUrl":"https://doi.org/10.2174/0115748863355533241202110934","url":null,"abstract":"","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827652","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":"SGLT-2 Inhibitors as an Effective Treatment for Type 2 Diabetes Mellitus, Hypertension, and Hyperuricemia - A Mechanistic Perspective.","authors":"Sultan Al Rashid, Rajkapoor Balasubramanian, Naina Mohamed Pakkir Maideen","doi":"10.2174/0115748863344964241106051256","DOIUrl":"https://doi.org/10.2174/0115748863344964241106051256","url":null,"abstract":"","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142709369","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, Nirenjen S, Tamilanban T, Sivaraman Dhansekaran, 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":""},"PeriodicalIF":1.1,"publicationDate":"2024-11-05","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":"Role of Dual GIP and GLP-1 Receptor Agonist, Tirzepatide in the Management of Weight Loss; A Systematic Review.","authors":"Imran Rashid Rangraze, Shehla Khan, Adil Farooq Wali, Godfred Menezes, Manjunatha Goud, Muhammad Jabran","doi":"10.2174/0115748863330434241015125302","DOIUrl":"https://doi.org/10.2174/0115748863330434241015125302","url":null,"abstract":"<p><strong>Aim: </strong>The eventuality of tirzepatide, a binary GIP and GLP- 1 receptor agonist, as a treatment for rotundity and metabolic diseases is addressed in this comprehensive review.</p><p><strong>Background: </strong>A definition of tirzepatide is that it is an implicit intervention for rotundity, given its effectualness per the cure-dependent effect. Beyond the beneficial effects on body weight loss, tirzepatide also brings about an improvement in lipid biographies and insulin perceptivity, in harmony with binary receptor activation.</p><p><strong>Methodology: </strong>Assaying data from seven phases 3 trials, it's constantly shown that tirizepatide reduces body weight in a significant and clinically meaningful way for a variety of party biographies and lengths of time.</p><p><strong>Results: </strong>The drug's effect was supported by its favorable safety profile, which shows low prevalence rates of common adverse goods. Its efficacy in the management of type 2 diabetes is supported by relative evaluations, underscoring the inevitability of its breakthrough as a therapeutic volition. Treatment individualization is key, as evidenced by the tailor-made response proposed by group analysis based on birth BMI. The efficacy, safety, and demand for personalized treatment plans of tirzepatide are each supported in recommendations for clinical practice.</p><p><strong>Conclusion: </strong>Tirzepatide's eventuality as a long-term strategy for habitual rotundity is corroborated by long-term follow-up studies that show sustained weight loss. Indeed with these encouraging results, further study and clinical experience are demanded to completely comprehend the safety, optimal integration, and long-term effectiveness of tirzepatide in a multiplicity of patient populations.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557346","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":"https://doi.org/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":""},"PeriodicalIF":1.1,"publicationDate":"2024-10-31","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}