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
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
T-wave morphology abnormalities in the STREAM stage 1 trial
CONCLUSIONS: T-wave abnormalities may help identify patients at risk of QT prolongation on DR-TB treatment.TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02409290). Current Controlled Trial number, ISRCTN78372190.PMID:38462751 | DOI:10.1080/14740338.2024.2322116 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 11, 2024 Category: Drugs & Pharmacology Authors: Gareth Hughes William J Young Henry Bern Angela Crook Pier D Lambiase Ruth L Goodall Andrew J Nunn Sarah K Meredith Source Type: research
Tolerability and safety outcomes of first-line oral second-generation antipsychotics in patients with schizophrenia
Expert Opin Drug Saf. 2024 Mar 11. doi: 10.1080/14740338.2024.2328812. Online ahead of print.ABSTRACTINTRODUCTION: Antipsychotics are the foundation of pharmacologic treatment for schizophrenia. There are many oral antipsychotics available and given that these medications are generally considered comparably efficacious when titrated to an adequate dose, their varied tolerability and safety profiles become critically important for medication selection.AREAS COVERED: This paper reviews tolerability and safety considerations for first-line second-generation oral antipsychotics currently approved for the treatment of schizophr...
Source: Expert Opinion on Drug Safety - March 11, 2024 Category: Drugs & Pharmacology Authors: Kristen Ward Leslie Citrome Source Type: research
T-wave morphology abnormalities in the STREAM stage 1 trial
CONCLUSIONS: T-wave abnormalities may help identify patients at risk of QT prolongation on DR-TB treatment.TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02409290). Current Controlled Trial number, ISRCTN78372190.PMID:38462751 | DOI:10.1080/14740338.2024.2322116 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 11, 2024 Category: Drugs & Pharmacology Authors: Gareth Hughes William J Young Henry Bern Angela Crook Pier D Lambiase Ruth L Goodall Andrew J Nunn Sarah K Meredith Source Type: research
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
CONCLUSIONS: The Ibrutinib-Obinutuzumab combo has the highest risk of infection, atrial fibrillation and myelosuppression, the Ibrutinib-Lenalidomide combo has the highest risk of pyrexia. However, the Ibrutinib-Venetoclax combo has a lower risk of hemorrhage than monotherapy.PMID:38456691 | DOI:10.1080/14740338.2024.2327507 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 8, 2024 Category: Drugs & Pharmacology Authors: Sichun Xiang Rongbin Shen Jingjing Xiang Ni Zhu Jianyou Gu Jianping Shen Yu Zhang Hangping Ge Source Type: research
Disparities in drug safety practices in developing nations: focusing on underlying factors and implications for global health
Expert Opin Drug Saf. 2024 Mar 7:1-5. doi: 10.1080/14740338.2024.2326488. Online ahead of print.NO ABSTRACTPMID:38436276 | DOI:10.1080/14740338.2024.2326488 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 4, 2024 Category: Drugs & Pharmacology Authors: Ahmad Z Al Meslamani Derar H Abdel-Qader Amira B Kassem Nadia Al Mazrouei Source Type: research
Disparities in Drug Safety Practices in Developing Nations: focusing on underlying factors and implications for global health
Expert Opin Drug Saf. 2024 Mar 4. doi: 10.1080/14740338.2024.2326488. Online ahead of print.NO ABSTRACTPMID:38436276 | DOI:10.1080/14740338.2024.2326488 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 4, 2024 Category: Drugs & Pharmacology Authors: Ahmad Z Al Meslamani Derar H Abdel-Qader Amira B Kassem Nadia Al Mazrouei Source Type: research
Chemical-induced liver cancer: an adverse outcome pathway perspective
Expert Opin Drug Saf. 2024 Mar 2. doi: 10.1080/14740338.2024.2326479. Online ahead of print.ABSTRACTINTRODUCTION: 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 the mechanistic understanding of toxicity.AREAS COVERED: Adverse outcome pathways (AOPs) present toxicological processes, including chemical-induced carcinogenicity, in a visual and comprehensive manner, which serve as the conceptual backbone for the development of non-animal approaches eligible for hazard identificatio...
Source: Expert Opinion on Drug Safety - March 2, 2024 Category: Drugs & Pharmacology Authors: Julen Sanz-Serrano Ellen Callewaert Sybren De Boever Annika Drees Anouk Verhoeven Mathieu Vinken Source Type: research
