A comparative safety review of targeted therapies for acute myeloid leukemia
Expert Opin Drug Saf. 2023 Nov 28. doi: 10.1080/14740338.2023.2289176. Online ahead of print.ABSTRACTINTRODUCTION: 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 for the treatment of AML. We performed a comparative analysis of the unique safety profile of each of these new agents.AREAS COVERED: We conducted a review of the current literature on public databases (PubMed, ClinicalTrials.gov, and U.S. Food and Drug Administration) regarding new AML drugs that were approved from 2...
Source: Expert Opinion on Drug Safety - November 28, 2023 Category: Drugs & Pharmacology Authors: Mark Dalgetty Christian Leurinda Jorge Cortes Source Type: research
Urinary tract infections and genital mycotic infections associated with SGLT ‑2 inhibitors: an analysis of the FDA Adverse event Reporting system
CONCLUSIONS: Data mining in the FAERS database suggests strong association between SGLT-2 inhibitors and UTIs/GMIs. These findings provide real-world evidence on the potential risk of UTIs/GMIs related to SGLT-2 inhibitors.PMID:38009230 | DOI:10.1080/14740338.2023.2288897 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 27, 2023 Category: Drugs & Pharmacology Authors: Ting Yang Ying Zhou Yimin Cui Source Type: research
New exploration of signal detection from the perspective of data mining: a pharmacovigilance analysis based on spontaneous reporting data in Zhenjiang, China
CONCLUSIONS: In this study, we attempted a new way to find potential drug risks using small spontaneous reporting data. Our findings also suggested the need for more precise identification of allergic risks and the improvement of traditional Chinese medicine labels.PMID:38009292 | DOI:10.1080/14740338.2023.2288143 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 27, 2023 Category: Drugs & Pharmacology Authors: Yuan Liu Xiaoli Xu Jingfei Yang Yuwei Zhang Mengjiao He Wenzhi Liao Na Wang Pengcheng Liu Source Type: research
Interstitial lung disease and CDK4/6 inhibitors in the treatment of breast cancer
Expert Opin Drug Saf. 2023 Nov 23:1-8. doi: 10.1080/14740338.2023.2288147. Online ahead of print.ABSTRACTINTRODUCTION: 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 clinicians are aware and learning how to manage common adverse events, such as bone marrow suppression and gastrointestinal toxicities, there are less common and potentially severe adverse events, such as interstitial lung disease (ILD), that require special consideration.AREAS COVERED: In this narrative review, we dis...
Source: Expert Opinion on Drug Safety - November 23, 2023 Category: Drugs & Pharmacology Authors: Ilana Schlam Antonio Giordano Sara M Tolaney Source Type: research
Interstitial lung disease and CDK4/6 inhibitors in the treatment of breast cancer
Expert Opin Drug Saf. 2023 Nov 23. doi: 10.1080/14740338.2023.2288147. Online ahead of print.ABSTRACTINTRODUCTION: 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 clinicians are aware and learning how to manage common adverse events, such as bone marrow suppression and gastrointestinal toxicities, there are less common and potentially severe adverse events, such as interstitial lung disease (ILD), that require special consideration.AREAS COVERED: In this narrative review, we discuss...
Source: Expert Opinion on Drug Safety - November 23, 2023 Category: Drugs & Pharmacology Authors: Ilana Schlam Antonio Giordano Sara M Tolaney Source Type: research
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
CONCLUSION: Evidence from the post-marketing safety data analysis identified a strong association between incretin mimetics and pancreatic events. Fewer events in RCTs may justify insignificant meta-analysis results.PMID:37986140 | DOI:10.1080/14740338.2023.2284992 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 21, 2023 Category: Drugs & Pharmacology Authors: Asif Muhammad Christy Thomas Vivekanandan Kalaiselvan Krishna Undela Source Type: research
Newly identified adverse events for gemcitabine using the Food and Drug Administration Adverse Event Reporting System
CONCLUSION: Our study identified previously undetected signals following gemcitabine treatment, thereby providing new insights for future medication guidance.PMID:37974405 | DOI:10.1080/14740338.2023.2284989 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 17, 2023 Category: Drugs & Pharmacology Authors: Wei Zhang Yuhong Wang Xin Jiang Hu Zhao Xinli Jia Qiye Wang Yue Chen Yuanfang Jiang Zhifang Ma Lina Chang Xin Wang Source Type: research
Newly identified adverse events for gemcitabine using the food and drug administration adverse event Reporting system
CONCLUSION: Our study identified previously undetected signals following gemcitabine treatment, thereby providing new insights for future medication guidance.PMID:37974405 | DOI:10.1080/14740338.2023.2284989 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 17, 2023 Category: Drugs & Pharmacology Authors: Wei Zhang Yuhong Wang Xin Jiang Hu Zhao Xinli Jia Qiye Wang Yue Chen Yuanfang Jiang Zhifang Ma Lina Chang Xin Wang Source Type: research
Hospital registration of adverse drug reactions in electronic health records: importance and contribution to pharmacovigilance
CONCLUSIONS: Hospital registrations of ADRs in EHRs provide information on ADRs, which are challenging to assess during clinical trials. However, improvements are required to optimize this registration before it can serve as a valuable data source for pharmacovigilance purposes.PMID:37961907 | DOI:10.1080/14740338.2023.2282582 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 14, 2023 Category: Drugs & Pharmacology Authors: Roba Alloush Jette van Lint Rob J van Marum Walter W A J J Hermens Naomi T Jessurun Source Type: research
Hospital registration of Adverse Drug Reactions in Electronic health records: importance and contribution to pharmacovigilance
CONCLUSION: Hospital registrations of ADRs in EHRs provide information on ADRs which are challenging to assess during clinical trials. However, improvements are required to optimize this registration before it can serve as a valuable data source for pharmacovigilance purposes.PMID:37961907 | DOI:10.1080/14740338.2023.2282582 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 14, 2023 Category: Drugs & Pharmacology Authors: Roba A Alloush Jette van Lint Rob J van Marum Walter W A J J Hermens Naomi T Jessurun Source Type: research
