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
CONCLUSIONS: Our concept and resulting algorithm are consistent, transparent, and easyto follow, and the method for derivation from consensus-based thresholds may also be applicableto other drug toxicity areas.PMID:38482670 | DOI:10.1080/14740338.2024.2327509 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Michael Merz Anna Fettiplace John Marcinak Hans L Tillmann Don C Rockey Gerd A Kullak-Ublick Source Type: research
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
CONCLUSION: Based on this real-world pharmacovigilance analysis, this study demonstrated a significant association between ribociclib and QTp/TdP events, which should attract clinical attention. The QT interval was monitored before and after medication. Attention should be given to adjusting the drugson time.PMID:38482864 | DOI:10.1080/14740338.2024.2307375 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Yu Yan Bin Wu Ling Wang Source Type: research
A safety review of tyrosine kinase inhibitors for chronic myeloid leukemia
Expert Opin Drug Saf. 2024 Mar 14. doi: 10.1080/14740338.2024.2331190. Online ahead of print.ABSTRACTINTRODUCTION: 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 issuesregarding TKI safety.AREAS COVERED: The aim of this review is to compare the side effectsof current TKIs both in the first- and later lines and outline a safety andprofile of CML treatment. Seminal studies on TKIs and other newer drugs andextended follow-up of these studies, real-life data of each drug were useddur...
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Deniz Özmen Duygu Demet Alpayd ın Muhammed Ali Saldo ğan Ahmet Emre E şkazan Source Type: research
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
CONCLUSIONS: Our concept and resulting algorithm are consistent, transparent, and easyto follow, and the method for derivation from consensus-based thresholds may also be applicableto other drug toxicity areas.PMID:38482670 | DOI:10.1080/14740338.2024.2327509 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Michael Merz Anna Fettiplace John Marcinak Hans L Tillmann Don C Rockey Gerd A Kullak-Ublick Source Type: research
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
CONCLUSION: Based on this real-world pharmacovigilance analysis, this study demonstrated a significant association between ribociclib and QTp/TdP events, which should attract clinical attention. The QT interval was monitored before and after medication. Attention should be given to adjusting the drugson time.PMID:38482864 | DOI:10.1080/14740338.2024.2307375 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Yu Yan Bin Wu Ling Wang Source Type: research
A safety review of tyrosine kinase inhibitors for chronic myeloid leukemia
Expert Opin Drug Saf. 2024 Mar 14. doi: 10.1080/14740338.2024.2331190. Online ahead of print.ABSTRACTINTRODUCTION: 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 issuesregarding TKI safety.AREAS COVERED: The aim of this review is to compare the side effectsof current TKIs both in the first- and later lines and outline a safety andprofile of CML treatment. Seminal studies on TKIs and other newer drugs andextended follow-up of these studies, real-life data of each drug were useddur...
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Deniz Özmen Duygu Demet Alpayd ın Muhammed Ali Saldo ğan Ahmet Emre E şkazan Source Type: research
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
CONCLUSIONS: Our concept and resulting algorithm are consistent, transparent, and easyto follow, and the method for derivation from consensus-based thresholds may also be applicableto other drug toxicity areas.PMID:38482670 | DOI:10.1080/14740338.2024.2327509 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Michael Merz Anna Fettiplace John Marcinak Hans L Tillmann Don C Rockey Gerd A Kullak-Ublick Source Type: research
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
CONCLUSION: Based on this real-world pharmacovigilance analysis, this study demonstrated a significant association between ribociclib and QTp/TdP events, which should attract clinical attention. The QT interval was monitored before and after medication. Attention should be given to adjusting the drugson time.PMID:38482864 | DOI:10.1080/14740338.2024.2307375 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Yu Yan Bin Wu Ling Wang Source Type: research
A safety review of tyrosine kinase inhibitors for chronic myeloid leukemia
Expert Opin Drug Saf. 2024 Mar 14. doi: 10.1080/14740338.2024.2331190. Online ahead of print.ABSTRACTINTRODUCTION: 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 issuesregarding TKI safety.AREAS COVERED: The aim of this review is to compare the side effectsof current TKIs both in the first- and later lines and outline a safety andprofile of CML treatment. Seminal studies on TKIs and other newer drugs andextended follow-up of these studies, real-life data of each drug were useddur...
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Deniz Özmen Duygu Demet Alpayd ın Muhammed Ali Saldo ğan Ahmet Emre E şkazan Source Type: research
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
CONCLUSIONS: Our concept and resulting algorithm are consistent, transparent, and easyto follow, and the method for derivation from consensus-based thresholds may also be applicableto other drug toxicity areas.PMID:38482670 | DOI:10.1080/14740338.2024.2327509 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Authors: Michael Merz Anna Fettiplace John Marcinak Hans L Tillmann Don C Rockey Gerd A Kullak-Ublick Source Type: research
Analysis of drug-induced posterior reversible encephalopathy syndrome using the food and drug administration adverse drug events reporting system database
CONCLUSION: Our results show that the drugs most commonly suspected to cause PRES were antineoplastics, immunosuppressants, and glucocorticoids. Future studies are needed to illuminate the pathophysiological alterations that underlie PRES. In the meantime, prescribers and patients should be made aware of the potential risks of PRES associated with pharmaceutical therapy, and the summaries of product characteristics for individual drugs should be updated to include this information.PMID:38478961 | DOI:10.1080/14740338.2024.2327510 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 13, 2024 Category: Drugs & Pharmacology Authors: Cai-Lu Lei Xiao-Long Gui Lin-Yu Wang You-Jia Guo Yan Li Source Type: research
A comprehensive analysis of liver safety across zibotentan oncology trials: knowledge of the past offers new perspectives on the present
CONCLUSIONS: We found no evidence of zibotentan-related liver biochemistry changes among cancer-treated patients, suggesting that hepatotoxicity of ERAs is molecule-dependent, and allowing exploration of zibotentan for new indications.PMID:38469902 | DOI:10.1080/14740338.2024.2328816 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 12, 2024 Category: Drugs & Pharmacology Authors: Anna Fettiplace Sherri Matis-Mitchell Oleksandr Molodetskyi Malin S öderbergh Jan Oscarsson Min Lin Srivathsa Ravikiran Martin Billger Philip Ambery Source Type: research
Dupilumab in real-life settings: a review of adverse events and their pathogenesis
Expert Opin Drug Saf. 2024 Mar 12:1-9. doi: 10.1080/14740338.2024.2326480. Online ahead of print.ABSTRACTINTRODUCTION: 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 involvement, nasopharyngitis, and injection site reactions in clinical trials. Anyway, its use in daily practice is revealing novel dupilumab-induced manifestations.AREAS COVERED: Relevant English literature (real-life studies, case series, reviews, and meta-analyses) regarding real-life adverse events induced by dupilumab...
Source: Expert Opinion on Drug Safety - March 12, 2024 Category: Drugs & Pharmacology Authors: Elisa Camela Anna Rita Giampetruzzi Ornella De Pit à Sabatino Pallotta Filomena Russo Source Type: research
A comprehensive analysis of liver safety across zibotentan oncology trials: knowledge of the past offers new perspectives on the present
CONCLUSIONS: We found no evidence of zibotentan-related liver biochemistry changes among cancer-treated patients, suggesting that hepatotoxicity of ERAs is molecule-dependent, and allowing exploration of zibotentan for new indications.PMID:38469902 | DOI:10.1080/14740338.2024.2328816 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 12, 2024 Category: Drugs & Pharmacology Authors: Anna Fettiplace Sherri Matis-Mitchell Oleksandr Molodetskyi Malin S öderbergh Jan Oscarsson Min Lin Srivathsa Ravikiran Martin Billger Philip Ambery Source Type: research
