Safety of daratumumab in the real-world: a pharmacovigilance study based on FAERS database
CONCLUSION: Our findings were consistent with the resultsof established studies that daratumumab has a good safety profile. The newlyidentified AEs are of concern and prospective clinical studies are needed toconfirm whether they are causally related to daratumumab. This study providedan early warning for the safe use of daratumumab and also provided guidance forfurther safety studies.PMID:38108285 | DOI:10.1080/14740338.2023.2296966 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 18, 2023 Category: Drugs & Pharmacology Authors: Junlin Wu Hanbiao Wu Lili Chen Haiping Liang Guoning Huang Sensen Yang Bishan Chen Yoshihiro Noguchi Yonggang Shen Source Type: research

Comparative study on the occurrence of adverse effects in the concomitant use of azathioprine and aldehyde oxidase inhibitors
CONCLUSION: Concomitant use of AO inhibitors increased the signals for AZA-induced adverse effects. To date, no studies have evaluated the clinical importance of AO as a drug-metabolizing enzyme, and further in vitro and clinical research is needed to clarify the contribution of AO to the pharmacokinetics of thiopurines.PMID:38097359 | DOI:10.1080/14740338.2023.2295976 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 14, 2023 Category: Drugs & Pharmacology Authors: Hinata Ueda Katsuya Narumi Shuho Asano Yoshitaka Saito Ayako Furugen Masaki Kobayashi Source Type: research

Comparative study on the occurrence of adverse effects in the concomitant use of azathioprine and aldehyde oxidase inhibitors
CONCLUSION: Concomitant use of AO inhibitors increased the signals for AZA-induced adverse effects. To date, no studies have evaluated the clinical importance of AO as a drug-metabolizing enzyme, and further in vitro and clinical research is needed to clarify the contribution of AO to the pharmacokinetics of thiopurines.PMID:38097359 | DOI:10.1080/14740338.2023.2295976 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 14, 2023 Category: Drugs & Pharmacology Authors: Hinata Ueda Katsuya Narumi Shuho Asano Yoshitaka Saito Ayako Furugen Masaki Kobayashi Source Type: research

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)
CONCLUSIONS: Using the Bradford Hill criteria however and taking into consideration confounders, no causal link between GLP-1 RAs and suicidality exists.PMID:38087976 | DOI:10.1080/14740338.2023.2295397 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 13, 2023 Category: Drugs & Pharmacology Authors: Roger S McIntyre Rodrigo B Mansur Joshua D Rosenblat Angela T H Kwan Source Type: research

Long QT syndrome after using EGFR-TKIs in older patients with advanced non-small cell lung cancer
CONCLUSIONS: Given the elevated risk of LQTS associated with osimertinib user, close monitoring for cardiac rhythm irregularities of high-risk patients following initiation of EGFR-TKI is recommended.PMID:38088244 | DOI:10.1080/14740338.2023.2294924 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 13, 2023 Category: Drugs & Pharmacology Authors: Joo-Young Byun Sola Han Aiham Qdaisat Chanhyun Park Source Type: research

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)
CONCLUSIONS: Using the Bradford Hill criteria however and taking into consideration confounders, no causal link between GLP-1 RAs and suicidality exists.PMID:38087976 | DOI:10.1080/14740338.2023.2295397 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 13, 2023 Category: Drugs & Pharmacology Authors: Roger S McIntyre Rodrigo B Mansur Joshua D Rosenblat Angela T H Kwan Source Type: research

Long QT syndrome after using EGFR-TKIs in older patients with advanced non-small cell lung cancer
CONCLUSIONS: Given the elevated risk of LQTS associated with osimertinib user, close monitoring for cardiac rhythm irregularities of high-risk patients following initiation of EGFR-TKI is recommended.PMID:38088244 | DOI:10.1080/14740338.2023.2294924 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 13, 2023 Category: Drugs & Pharmacology Authors: Joo-Young Byun Sola Han Aiham Qdaisat Chanhyun Park Source Type: research

Model driven method for exploring individual and confounding effects in spontaneous adverse event reporting databases
CONCLUSION: The study underscored that MD-ROR holds promise as a method for investigating individual and confounding effects in SAER databases.PMID:38073472 | DOI:10.1080/14740338.2023.2293200 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 11, 2023 Category: Drugs & Pharmacology Authors: Bo Lv Yuedong Li Aiming Shi Jie Pan Source Type: research

Priapism associated with anti-seizure medications: a pharmacovigilance study and a review of published cases
CONCLUSIONS: Our study identified signals for priapism for several anti-seizure medications, but these results need to be confirmed in well-designed pharmacoepidemiological studies.PMID:38062555 | DOI:10.1080/14740338.2023.2293208 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 8, 2023 Category: Drugs & Pharmacology Authors: Nemanja Z Petrovi ć Ana V Pej čić Ivan R Milovanovi ć Source Type: research

A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hypercholesterolemic patients
CONCLUSION: The pooled analysis of the existing evidence shows that inclisiran showed reduced risk of MACE along with excellent efficacy in managing dyslipidemia.PMID:38063346 | DOI:10.1080/14740338.2023.2293201 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 8, 2023 Category: Drugs & Pharmacology Authors: Siddhartha Dutta Rima Shah Shubha Singhal Surjit Singh Kiran Piparva Chandan Dev Singh Katoch Source Type: research

Impact of preoperative pharmaceutical care consultation on medication errors in surgical patients: a comprehensive analysis
CONCLUSIONS: This study highlights the effectiveness of pharmaceutical care consultations in preventing MEs and improving surgical outcomes.PMID:38063348 | DOI:10.1080/14740338.2023.2292710 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 8, 2023 Category: Drugs & Pharmacology Authors: Daniel Gomez Costas Almudena Ribed S ánchez Alvaro Gimenez Manzorro Ignacio Garutti Martinez Francisco Javier Sanz Fernandez Beatriz Torroba Sanz Sergio Herrero Bermejo Ana Mar ía Herranz-Alonso Mar ía Sanjurjo Source Type: research