Ustekinumab as induction and maintenance therapy for ulcerative colitis - national extended follow-up and a review of the literature
CONCLUSION: For moderate-to-severe UC in Australia, ustekinumab maintained efficacy beyond 3 years with a high persistence rate and no new safety signals.TRIAL REGISTRATION: The trial is registered at ANZCTR (identifier: ACTRN12622001332718).PMID:37909484 | DOI:10.1080/14740338.2023.2278686 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 1, 2023 Category: Drugs & Pharmacology Authors: J D Chetwood S Gupta K Subramaniam P De Cruz G Moore Y K An S J Connor M Kermeen S Paramsothy R W Leong Source Type: research
Drug-induced hypoglycemia: a disproportionality analysis of the FAERS database
CONCLUSIONS: By analyzing the FAERS database, we listed drugs with a strong hypoglycemic signal for which the label does not provide a reminder. Notably, the potential hypoglycemia risks are of great importance and should be closely monitored in medical practice.KEWORDS: hypoglycemia, FAERS, disproportionality analysis, pharmacovigilance.PMID:37909653 | DOI:10.1080/14740338.2023.2278700 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 1, 2023 Category: Drugs & Pharmacology Authors: Jie Li Yilei Wang Xiang Yang Haohao Zhu Zhitao Jiang Source Type: research
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
CONCLUSIONS: Identifying the giant quantitate association between nimesulide and serious & life-threatening reactions like SJS and TEN, precautionary measures need to be taken by the regulatory authorities to prevent nimesulide-induced SSTDs among the pediatric population.PMID:37908194 | DOI:10.1080/14740338.2023.2274416 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 1, 2023 Category: Drugs & Pharmacology Authors: Krishna Undela Vivekanandan Kalaiselvan Sai Krishna Gudi Subeesh K Viswam Syed Kashif Ali Source Type: research
A safety review of recently approved and emerging drugs for patients with relapsed or refractory multiple myeloma
Expert Opin Drug Saf. 2023 Oct 31. doi: 10.1080/14740338.2023.2274420. Online ahead of print.ABSTRACTINTRODUCTION: 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 familiarize themselves with common toxicities associated with these drugs and with novel toxicities requiring specific management and supportive care.AREAS COVERED: We review common toxicities associated with agents approved for RRMM in the past 5 years, including the anti-CD38 monoclonal antibody isatuximab, the antibody ...
Source: Expert Opinion on Drug Safety - October 31, 2023 Category: Drugs & Pharmacology Authors: 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 Source Type: research
A pharmacovigilance study on drug-induced liver injury associated with antibody-drug conjugates (ADCs) based on the food and drug administration adverse event reporting system
CONCLUSIONS: The FAERS data mining suggested an association between DILI and some ADCs. Further studies are warranted to unraveling the underlying mechanisms and take preventive measures for ADCs-related DILI.PMID:37898875 | DOI:10.1080/14740338.2023.2277801 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 29, 2023 Category: Drugs & Pharmacology Authors: Cuicui Sun Xiaoyan Yang Linlin Tang Jinhua Chen Source Type: research
Real-world safety of icosapent ethyl: analysis based on spontaneous reports in FAERS database
CONCLUSIONS: This study provides a comprehensive real-world safety profile of IPE, which indicates that IPE is well-tolerated.PMID:37873598 | DOI:10.1080/14740338.2023.2274946 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Authors: Haixia Cai Beixi Jia Zhonghua Fu Boya Chen Yinping Liu Shujuan Zhao Source Type: research
Real-world safety of icosapent ethyl: Analysis Based on Spontaneous Reports in FAERS database
CONCLUSIONS: This study provides a comprehensive real-world safety profile of IPE, which indicates that IPE is well-tolerated.PMID:37873598 | DOI:10.1080/14740338.2023.2274946 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Authors: Haixia Cai Beixi Jia Zhonghua Fu Boya Chen Yinping Liu Shujuan Zhao Source Type: research
Safety of current treatment options for NTRK fusion-positive cancers
Expert Opin Drug Saf. 2023 Oct 23. doi: 10.1080/14740338.2023.2274426. Online ahead of print.ABSTRACTINTRODUCTION: 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 tropomyosin receptor kinase inhibitors (TRKi) larotrectinib and entrectinib are among the first agents with tissue agnostic FDA approvals for cancer treatment, and additional TRKi are undergoing development. As experience with TRKi grow, novel mechanisms of resistance and on/off target side effects have become increa...
Source: Expert Opinion on Drug Safety - October 23, 2023 Category: Drugs & Pharmacology Authors: Adeline T Yang Theodore Willis Laetsch Source Type: research
Balancing the risk of stroke and bleeding in atrial fibrillation patients with a history of falls
Expert Opin Drug Saf. 2023 Oct 20. doi: 10.1080/14740338.2023.2273333. Online ahead of print.ABSTRACTINTRODUCTION: 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 be reduced by anticoagulation, however many patients with high falls risk do not receive oral anticoagulation.AREAS COVERED: In this narrative literature review, performed with searches of the PubMed database, we discuss the factors predisposing AF patients to falls, ways to optimize bleeding risk with individualized...
Source: Expert Opinion on Drug Safety - October 20, 2023 Category: Drugs & Pharmacology Authors: Nang Khaing Zar Latt Peter Calvert Gregory Y H Lip Source Type: research
