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Hemorrhage induced by antithrombotic agents: new insights from a real-world pharmacovigilance study Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-18 Kangyuan Guo, Ganyi Wang, Li Zhang, Zhanchun Feng, Xudong Xia, Xiaobo Sun, Ziqi Yan, Zhiming Jiao, Da Feng
Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time...
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A comprehensive analysis of liver safety across zibotentan oncology trials: knowledge of the past offers new perspectives on the present. Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-12 Anna Fettiplace, Sherri Matis-Mitchell, Oleksandr Molodetskyi, Malin Söderbergh, Jan Oscarsson, Min Lin, Srivathsa Ravikiran, Martin Billger, Philip Ambery
Endothelin receptor antagonists (ERAs) are associated with liver injury. We used data from previous oncology clinical trials to determine the liver safety profile of zibotentan, which is currently ...
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A safety review of tyrosine kinase inhibitors for chronic myeloid leukemia Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-14 Deniz Özmen, Duygu Demet Alpaydın, Muhammed Ali Saldoğan, Ahmet Emre Eşkazan
Since the introduction of first tyrosine kinase inhibitor(TKI) imatinib, treatment of chronic myeloid leukemia (CML) has reachedexcellent survival expectancies. Long survival rates bring about issu...
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Liver toxicity in oncology trials and beyond: a simplified concept for management of hepatocellular drug-induced liver injury in patients with abnormal baseline liver tests Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-14 Michael Merz, Anna Fettiplace, John Marcinak, Hans L Tillmann, Don C. Rockey, Gerd A Kullak-Ublick
Management of side effects in clinical trials has to balance generationof meaningful data with risk for patients. A toxicity area requiring detailedmanagement guidelines is drug-induced liver injur...
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Analysis of drug-induced posterior reversible encephalopathy syndrome using the food and drug administration adverse drug events reporting system database Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-13 Cai-Lu Lei, Xiao-Long Gui, Lin-Yu Wang, You-Jia Guo, Yan Li
In this retrospective pharmacovigilance study, we gathered data on drug-induced posterior reversible encephalopathy syndrome (PRES). Our goal was to identify the primary suspect drugs in PRES by an...
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T-wave morphology abnormalities in the STREAM stage 1 trial Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-10 Gareth Hughes, William J. Young, Henry Bern, Angela Crook, Pier D. Lambiase, Ruth L. Goodall, Andrew J. Nunn, Sarah K. Meredith
Shorter regimens for drug-resistant tuberculosis (DR-TB) have non-inferior efficacy compared with longer regimens, but QT prolongation is a concern. T-wave morphology abnormalities may be a predict...
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A real-world pharmacovigilance study of QT interval prolongation and Torsades de Pointes associated with CDK4/6 inhibitors in breast cancer patients: findings from the FDA adverse event reporting system Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-14 Yu Yan, Bin Wu, Ling Wang
The aim of this study was to evaluate the association between CDK4/6 inhibitors and QT interval prolongation (QTp) and Torsades de Pointes (TdP) in breast cancer patients.The cases with breast canc...
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Dupilumab in real-life settings: a review of adverse events and their pathogenesis Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-12 Elisa Camela, Anna Rita Giampetruzzi, Ornella De Pità, Sabatino Pallotta, Filomena Russo
Dupilumab is a safe and effective biological drug that revolutionized the treatment of atopic dermatitis (AD). Concerning adverse events (AEs), the most commonly reported included ocular involvemen...
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Tolerability and safety outcomes of first-line oral second-generation antipsychotics in patients with schizophrenia Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-11 Kristen Ward, Leslie Citrome
Antipsychotics are the foundation of pharmacologic treatment for schizophrenia. There are many oral antipsychotics available and given that these medications are generally considered comparably eff...
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A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for Bruton’s tyrosine kinase inhibitors (BTKis) single and its combination therapy Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-08 Sichun Xiang, Rongbin Shen, Jingjing Xiang, Ni Zhu, Jianyou Gu, Jianping Shen, Yu Zhang, Hangping Ge
Bruton’s tyrosine kinase inhibitors (BTKis) are targeted treatments for B-cell tumors but have significant side effects,This study assesses and contrasts the side effects of BTKis alone and its fou...
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Chemical-induced liver cancer: an adverse outcome pathway perspective Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-02 Julen Sanz-Serrano, Ellen Callewaert, Sybren De Boever, Annika Drees, Anouk Verhoeven, Mathieu Vinken
The evaluation of the potential carcinogenicity is a key consideration in the risk assessment of chemicals. Predictive toxicology is currently switching toward non-animal approaches that rely on th...
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Disparities in Drug Safety Practices in Developing Nations: focusing on underlying factors and implications for global health Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-03-04 Ahmad Z. Al Meslamani, Derar H. Abdel-Qader, Amira B. Kassem, Nadia Al Mazrouei
Published in Expert Opinion on Drug Safety (Just accepted, 2024)
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Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS) Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-02-26 Xiaomei Xiong, Xiuwen Zhang, Xiaoxia Li, Taomin Huang
The safety information of brolucizumab primarily comes from clinical trials experience. This study aimed to explore the ocular and systemic adverse events (AEs) associated with brolucizumab among r...
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Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-02-11 Daniel A. Salmon, Robert T. Chen, Steve Black, Joshua Sharfstein
Vaccine pharmacovigilance is an essential component of vaccine safety programs. Vaccine pharmacovigilance refers to detecting uncommon adverse events following immunization (AEFI), determining whet...
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Anticancer drug-induced interstitial lung disease: a critical appraisal of clinical practice guidelines and consensus statements Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-02-07 Zhuo Ma, Yi Zhang, Ximu Sun, Yuhui Zhang, Min Zhu, Shu Zhang, Xin Feng, Zhuoling An
Anticancer drug-induced interstitial lung disease (DIILD) has received increasing clinical attention, and the quality of relevant guidance documents has become critical. Our purpose was to assess t...
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Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-30 Ling Liu, Chengyi Zhang, Huihui Liu, Huan Luo, Rong Cao, Mingxuan Xiao, Pan Zou, Zhuzhu Xie, Hui Gong, Rui Ma, Miao Yan, Zhichao Jiang
Hepatic cancer is a common cancer in clinical practice. Current drug therapies for this condition include targeted therapy, chemotherapy, and immunotherapy. Tumor lysis syndrome (TLS) is the most s...
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Hematological adverse events associated with anti-MRSA agents: a real-world analysis based on FAERS Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-22 Xiuheng Yu, Xiaodan Zhou, Min Li, Yu Zhao
This study investigated the patterns of hematological adverse events related to daptomycin (DAP), tigecycline (TIG), vancomycin (VAN) and linezolid (LIN) in the FDA Adverse Event Reporting System (...
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Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-22 Jae Hyun Kim, Yun-Kyoung Song
Through the use of FDA adverse event reporting system (FAERS) dataset, this study analyzes the pattern of time-to-event (TTE) for drugs and adverse events, and suggest ways to identify candidate la...
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Influence of prior treatment protocol on intravitreal dexamethasone implant behavior in patients with diabetic macular edema in real-world practice Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-17 Almudena Moreno-Martinez, Cristina Blanco-Marchite, Sergio Copete
Intravitreal dexamethasone implant (DEXI) has been placed as an effective option to treat diabetic macular edema (DME). However, there is no consensus on the best time to introduce it. We conducted...
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Generic pharmaceuticals, regulatory aspects, bioequivalence investigation, and perception Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-17 Ravi Bhushan, Jürgen Martens
The objective and significance of the topic is to draw attention toward regulatory aspects (and pharmacopoeias) for bioequivalence investigation, and perception for generic pharmaceuticals, especia...
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Why are outcome-based drug safety research studies scarce? Insights into operational challenges and potential solutions Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-17 Ahmad Z. Al Meslamani
Published in Expert Opinion on Drug Safety (Vol. 23, No. 2, 2024)
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Comparative safety review of antithrombotic treatment options for patients with atrial fibrillation undergoing percutaneous coronary intervention Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-17 Muhammed Ibrahim Erbay, Nikolaos Pyrpyris, Shriraj Susarla, Sebahat Ulusan, Adriana C. Mares, Tasha Phillips Wilson, Duo Lee, Aayushi Sood, Rahul Gupta
Balancing antithrombotic therapy for atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI) remains a clinical challenge due to coexisting thrombogenic risks. This re...
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Effects of adding adjuvants to propofol on the post-anesthesia cognitive function in patients undergoing gastroscopy/colonoscopy: a systematic review and meta-analysis Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2024-01-13 Liupu Zheng, Mengqian Ye, Jun Ma, Chen Jin, Yan Yang, Haoqi Li, Rongyuan Zheng, Yi Wang
This study aimed to elucidate the effects of propofol plus adjuvants on postoperative cognitive dysfunction (POCD) and patient satisfaction.Studies published up to September 2023 on the Chinese Nat...
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A safety evaluation of ruxolitinib for the treatment of polycythemia vera Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-29 Valentina Boldrini, Alessandro M. Vannucchi, Paola Guglielmelli
Polycythemia Vera (PV) is a chronic myeloproliferative neoplasm hallmarked by deregulated proliferation of hematopoietic stem cells leading to prevalent expansion of red cell mass, increased rate o...
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Safety and effectiveness of fifth generation cephalosporins for the treatment of methicillin-resistant staphylococcus aureus bloodstream infections: a Narrative Review Exploring past, present and future Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-25 Davide Fiore Bavaro, Alessandra Belati, Linda Bussini, Valeria Cento, Lucia Diella, Milo Gatti, Annalisa Saracino, Federico Pea, Pierluigi Viale, Michele Bartoletti
Methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSIs) is a major issue in healthcare, since it is often associated with endocarditis or deep site foci. Relevant morbidity...
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Safety and effectiveness of rasagiline in patients with Parkinson’s disease in Japan: a post-marketing surveillance study Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-20 Nobutaka Hattori, Mika Kajita, Shinji Fujimoto, Miwa Izutsu, Jovelle Fernandez
Rasagiline is a monoamine oxidase B inhibitor for the treatment of Parkinson’s disease (PD). This study assessed the safety and effectiveness of rasagiline in patients with PD in routine clinical p...
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Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-19 Yongtai Cho, Sungho Bea, Ji-Hwan Bae, Dong Hyun Kim, Jong Hee Lee, Ju-Young Shin
Finasteride is commonly prescribed for androgenic alopecia and benign prostatic hyperplasia. However, concerns regarding its safety have been growing as cases of cognitive dysfunction have been rep...
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A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-19 Siddhartha Dutta, Rima Shah, Shubha Singhal, Surjit Singh, Kiran Piparva, Chandan Dev Singh Katoch
Dyslipidaemia is a crucial risk factor for cardiovascular morbidity and mortality. A short interfering RNA called inclisiran diminishes circulating levels of PCSK9 and LDL-C by hindering PCSK9 tran...
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Safety of daratumumab in the real-world: a pharmacovigilance study based on FAERS database Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Junlin Wu, Hanbiao Wu, Lili Chen, Haiping Liang, Guoning Huang, Sensen Yang, Bishan Chen, Yoshihiro Noguchi, Yonggang Shen
Daratumumab is widely used in multiple myeloma (MM) and light chain amyloidosis(AL amyloidosis). The purpose of this study was to identify adverse event(AE) signals for daratumumab through the FDA ...
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Comparative study on the occurrence of adverse effects in the concomitant use of azathioprine and aldehyde oxidase inhibitors Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-14 Hinata Ueda, Katsuya Narumi, Shuho Asano, Yoshitaka Saito, Ayako Furugen, Masaki Kobayashi
Aldehyde oxidase (AO) is a molybdenum-containing redox enzyme similar to xanthine oxidase that is involved in the thiopurine metabolism. This study investigated the effects of drug-drug interaction...
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Cardiovascular safety of current and emerging drugs to treat anaemia in chronic kidney disease: a safety review Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Francesco Locatelli, Ernesto Paoletti, Lucia Del Vecchio
Erythropoiesis-stimulating agents (ESAs) are the standard of treatment for anemia in chronic kidney disease. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) are small molecules tha...
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Potential side effects of currently available pharmacotherapies in male lower urinary tract symptoms suggestive of benign prostatic hyperplasia Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 A. Elif Müderrisoglu, Jean J. M. C. H. de la Rosette, Martin C. Michel
The drug classes of α1-adrenoceptor antagonists, 5α-reductase inhibitors, and phosphodiesterase type 5 inhibitors are guideline-recommended treatments of lower urinary tract symptoms suggestive of ...
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Impact of preoperative pharmaceutical care consultation on medication errors in surgical patients: a comprehensive analysis Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Daniel Gomez Costas, Almudena Ribed Sánchez, Alvaro Gimenez Manzorro, Ignacio Garutti Martinez, Francisco Javier Sanz Fernandez, Beatriz Torroba Sanz, Sergio Herrero Bermejo, Ana María Herranz-Alonso, María Sanjurjo
Assessing the impact of introducing preoperative pharmaceutical care consultations by analyzing the severity of prevented medication errors (MEs) and their potential effects on the surgical process...
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Bleeding in acute coronary syndrome: from definitions, incidence, and prognosis to prevention and management Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Claudio Laudani, Davide Capodanno, Dominick Joseph Angiolillo
In patients with acute coronary syndrome (ACS), the ischemic benefit of antithrombotic treatment is counterbalanced by the risk of bleeding. The recognition that bleeding events have prognostic imp...
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A comparative safety review of targeted therapies for acute myeloid leukemia Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Mark Dalgetty, Christian Leurinda, Jorge Cortes
Acute myeloid leukemia (AML) treatment has primarily focused on 7 + 3 chemotherapy, but in the last decade there has been a significant increase in new therapies, mostly targeted agents, approved f...
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Nail lichen planus treatment safety Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Eden N. Axler, Shari R. Lipner
Lichen planus is a chronic inflammatory disorder that may cause significant nail changes and impair daily life. Nail lichen planus presents a therapeutic challenge, as the condition is progressive,...
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Interstitial lung disease and CDK4/6 inhibitors in the treatment of breast cancer Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Ilana Schlam, Antonio Giordano, Sara M. Tolaney
CDK4/6 inhibitors have changed the treatment paradigm of many patients living with metastatic and early-stage high-risk hormone receptor (HR)-positive breast cancer. Even though patients and clinic...
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The safety of oral antifungals for the treatment of onychomycosis Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Aditya K. Gupta, Sandor Haas-Neill, Mesbah Talukder
Oral antifungals are used for the treatment of moderate-severe onychomycosis. Terbinafine and itraconazole are approved for onychomycosis treatment in North America; additionally, fluconazole is in...
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Janus kinase inhibitor—Tofacitinib associated with pemphigus: an analysis of the FDA adverse event reporting system data Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-18 Li Wang, Bin Zhao
To establish the association between the therapy of Janus kinase inhibitors and the adverse event of pemphigus in patients with rheumatologic and inflammatory disorders.A disproportionality analysi...
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The association between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: reports to the Food and Drug Administration adverse event reporting system (FAERS) Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-13 Roger S. McIntyre, Rodrigo B. Mansur, Joshua D. Rosenblat, Angela T.H. Kwan
Recently, the European Medicines Agency (EMA) received reports of suicidal thoughts and self-injury associated with the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglu...
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Long QT syndrome after using EGFR-TKIs in older patients with advanced non-small cell lung cancer Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-13 Joo-Young Byun, Sola Han, Aiham Qdaisat, Chanhyun Park
Long QT syndrome (LQTS) has been reported in older patients with advanced non-small cell lung cancer (NSCLC) following the use of osimertinib, the third-generation epidermal growth factor receptor-...
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Model driven method for exploring individual and confounding effects in spontaneous adverse event reporting databases Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-11 Bo Lv, Yuedong Li, Aiming Shi, Jie Pan
Spontaneous Adverse Event Reporting (SAER) databases play a crucial role in post-marketing drug surveillance. However, the traditional model-free disproportionality analysis has been challenged by ...
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Priapism associated with anti-seizure medications: a pharmacovigilance study and a review of published cases Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-12-07 Nemanja Z. Petrović, Ana V. Pejčić, Ivan R. Milovanović
Recently, case reports of priapism associated with the use of some anti-seizure medications began to emerge in the literature. We aimed to investigate if there is a potential safety signal of priap...
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A real-world analysis of safety profile of selexipag by using FDA adverse event Reporting System (FAERS) Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-30 Jie Zhao, Mei Wang, Qing Yu, Yi Yang, Bin Zhang, Sanhua Zhan
The current investigation sought to conduct a real-world analysis of adverse events (AEs) associated with selexipag by utilizing data from the Food and Drug Administration Adverse Event Reporting S...
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New exploration of signal detection of Regional Risks from the perspective of data mining: a pharmacovigilance analysis based on spontaneous reporting data in Zhenjiang, China Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-27 Yuan Liu, Xiaoli Xu, Jingfei Yang, Yuwei Zhang, Mengjiao He, Wenzhi Liao, Na Wang, Pengcheng Liu
This study aimed to adopt the conventional signal detection methods to explore a new way of risk identification and to mine important drug risks from the perspective of big data based on Zhenjiang ...
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Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-28 Luca Potestio, Elisa Camela, Sara Cacciapuoti, Fabrizio Martora, Luigi Guerriero, Luigi Fornaro, Angelo Ruggiero, Matteo Megna
Generalized pustular psoriasis (GPP) is a rare form of psoriasis (less of 1% of cases). Currently, GPP is recognized as a clinical entity, distinguished from plaque psoriasis. However, there are no...
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An updated safety review of the current drugs for managing ADHD in children Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-28 Erika Ryst, Ann Childress
Attention-Deficit/Hyperactivity Disorder (ADHD) is a highly prevalent condition that causes persistent problems with attention and/or hyperactivity-impulsivity and often results in significant impa...
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Balancing the risk of stroke and bleeding in atrial fibrillation patients with a history of falls Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-28 Nang Khaing Zar Latt, Peter Calvert, Gregory Y. H. Lip
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and can lead to serious consequences such as ischemic stroke and systemic thromboembolism. The risk of thromboembolism can ...
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A safety review of recently approved and emerging drugs for patients with relapsed or refractory multiple myeloma Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-28 Shonali Midha, Monique A. Hartley-Brown, Clifton C. Mo, Shahrier Hossain, Omar Nadeem, Elizabeth K. O’Donnell, Giada Bianchi, Adam S. Sperling, Jacob P. Laubach, Paul G. Richardson
Multiple new drugs have been approved over the past 5 years for the treatment of relapsed/refractory multiple myeloma (RRMM), and these are being increasingly widely used. Clinicians need to famili...
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Safety of current treatment options for NTRK fusion-positive cancers Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-28 Adeline T. Yang, Theodore Willis Laetsch
Oncogenic NTRK fusions have been found in multiple cancer types affecting adults and/or children, including rare tumors with pathognomonic fusions and common cancers in which fusions are rare. The ...
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Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse event Reporting system Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-27 Ting Yang, Ying Zhou, Yimin Cui
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a class of antihyperglycemic agents, including canagliflozin, dapagliflozin, empagliflozin and ertugliflozin. Risk of urinary tract infections...
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Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-20 Asif Muhammad, Christy Thomas, Vivekanandan Kalaiselvan, Krishna Undela
The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications.A retrospective case/non-case study was conducted by using s...
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Newly identified adverse events for gemcitabine using the food and drug administration adverse event Reporting system Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-16 Wei Zhang, Yuhong Wang, Xin Jiang, Hu Zhao, Xinli Jia, Qiye Wang, Yue Chen, Yuanfang Jiang, Zhifang Ma, Lina Chang, Xin Wang
Our research aimed to identify previously undocumented adverse events (AEs) in the gemcitabine drug insert with the goal of informing clinical practice.We extracted adverse events associated with g...
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Hospital registration of adverse drug reactions in electronic health records: importance and contribution to pharmacovigilance Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-14 Roba Alloush, Jette van Lint, Rob J. van Marum, Walter W.A.J.J. Hermens, Naomi T. Jessurun
Information on registered adverse drug reactions (ADRs) in hospitals may provide a large real-world data source that can be used to ensure patients’ safety. This study aimed to assess the potential...
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The risk factors of diabetic ketosis and diabetic ketoacidosis among patients with type 2 diabetes mellitus treated with SGLT2 inhibitors: a retrospective study Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-10 Qingnan Zhao, Yijiong Tan, Qinqin Wu, Xiangqin Xiao, Xinyi Wei, Mengqing Nian, Jie Yao, Nengguang Fan, Ruiping Wang, Guorong Fan
There is limited evidence on the safety of sodium-glucose co-transporter-2 inhibitor (SGLT2i) use in the real world of China. We conducted this two-center, retrospective study to assess the inciden...
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Severe cutaneous adverse reactions due to antibiotics therapy: a pharmacovigilance analysis of FDA adverse event reporting system events Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-08 Lu Zhou, Jing Yang, Min Xiao, HuiFang Shan, MaoZhu Liu, Yun Lu, Ya Zou, Bin Wu
The aim of this study was to monitor, identify and evaluate severe cutaneous adverse reactions (SCAR) induced by antibiotics in patients.Disproportionality algorithms were performed in data mining ...
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Pneumatosis intestinalis associated with α-glucosidase inhibitors: a pharmacovigilance study of the FDA adverse event reporting system from 2004 to 2022 Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-06 Yiqian Chen, Yao Xiao, Guanghui Lian, Jun Yi, Xiaowei Liu
A-glucosidase inhibitors (AGIs) are suitable for type 2 diabetes mellitus patients with carbohydrate-rich diets while were reported associated with the rare but potentially life-threatening pneumat...
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Risk of serious skin and subcutaneous tissue disorders for nimesulide among the pediatric population: a jeopardy identified through the analysis of global individual case safety reports Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-01 Krishna Undela, Vivekanandan Kalaiselvan, Sai Krishna Gudi, Subeesh K. Viswam, Syed Kashif Ali
The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs).The global individual case safety reports on nimesulide-induced SSTDs...
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Association of temozolomide with progressive multifocal leukoencephalopathy: a disproportionality analysis integrated with network pharmacology Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-01 Vipin Bhati, Anoop Kumar, Viney Lather, Ruchika Sharma, Deepti Pandita
Temozolomide (TMZ) is an alkylating agent approved for the management of glioblastoma. The TMZ is not known for progressive multifocal leukoencephalopathy (PML). The main objective of the current s...
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Ustekinumab as induction and maintenance therapy for ulcerative colitis – national extended follow-up and a review of the literature Expert Opin. Drug Saf. (IF 3.1) Pub Date : 2023-11-01 JD. Chetwood, S. Gupta, K. Subramaniam, P. De Cruz, G. Moore, YK. An, SJ. Connor, M. Kermeen, S. Paramsothy, RW. Leong
Ustekinumab use in ulcerative colitis had shown low adverse event and high persistence rates to 3 years via the UNIFI long-term extension study. Outcomes beyond 3 years have not been previously des...