Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research
Janus kinase inhibitor-Tofacitinib associated with pemphigus: an analysis of the FDA adverse event reporting system data
CONCLUSION: Pemphigus, a rare and potentially fatal adverse event, was found to occur more frequently in patients receiving Tofacitinib. High-risk individuals were identified as female, age between 40-49, or with rheumatoid arthritis. Medication, adverse events, and underlying disease conditions were identified as potential contributing factors. Rheumatology and dermatology specialists should exercise increased vigilance in clinical practice.PMID:37722813 | DOI:10.1080/14740338.2023.2248872 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Li Wang Bin Zhao Source Type: research
Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research
Janus kinase inhibitor-Tofacitinib associated with pemphigus: an analysis of the FDA adverse event reporting system data
CONCLUSION: Pemphigus, a rare and potentially fatal adverse event, was found to occur more frequently in patients receiving Tofacitinib. High-risk individuals were identified as female, age between 40-49, or with rheumatoid arthritis. Medication, adverse events, and underlying disease conditions were identified as potential contributing factors. Rheumatology and dermatology specialists should exercise increased vigilance in clinical practice.PMID:37722813 | DOI:10.1080/14740338.2023.2248872 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Li Wang Bin Zhao Source Type: research
Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan ®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
CONCLUSIONS: YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.PMID:37674345 | DOI:10.1080/14740338.2023.2252341 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Stylianos Kandarakis Alexandros P Papadopoulos Georgios Roussopoulos Eustathios Georgopoulos Youngsik Chung Leonidas Doumazos Areum Baek Nefeli Ioanna Paizi Hyunik Shin Pantelis A Papadopoulos Source Type: research
Drug safety in Africa: a review of systems and resources for pharmacovigilance
Expert Opin Drug Saf. 2023 Sep 7:1-5. doi: 10.1080/14740338.2023.2251375. Online ahead of print.ABSTRACTINTRODUCTION: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.AREAS COVERED: This was an ...
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Helen Byomire Ndagije David Walusimbi Joanita Atuhaire Sheila Ampaire Source Type: research
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan ®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
CONCLUSIONS: YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.PMID:37674345 | DOI:10.1080/14740338.2023.2252341 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Stylianos Kandarakis Alexandros P Papadopoulos Georgios Roussopoulos Eustathios Georgopoulos Youngsik Chung Leonidas Doumazos Areum Baek Nefeli Ioanna Paizi Hyunik Shin Pantelis A Papadopoulos Source Type: research
Drug safety in Africa: a review of systems and resources for pharmacovigilance
Expert Opin Drug Saf. 2023 Sep 7:1-5. doi: 10.1080/14740338.2023.2251375. Online ahead of print.ABSTRACTINTRODUCTION: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.AREAS COVERED: This was an ...
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Helen Byomire Ndagije David Walusimbi Joanita Atuhaire Sheila Ampaire Source Type: research
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan ®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
CONCLUSIONS: YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.PMID:37674345 | DOI:10.1080/14740338.2023.2252341 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Stylianos Kandarakis Alexandros P Papadopoulos Georgios Roussopoulos Eustathios Georgopoulos Youngsik Chung Leonidas Doumazos Areum Baek Nefeli Ioanna Paizi Hyunik Shin Pantelis A Papadopoulos Source Type: research
Drug safety in Africa: a review of systems and resources for pharmacovigilance
Expert Opin Drug Saf. 2023 Sep 7:1-5. doi: 10.1080/14740338.2023.2251375. Online ahead of print.ABSTRACTINTRODUCTION: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.AREAS COVERED: This was an ...
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Helen Byomire Ndagije David Walusimbi Joanita Atuhaire Sheila Ampaire Source Type: research
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan ®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
CONCLUSIONS: YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.PMID:37674345 | DOI:10.1080/14740338.2023.2252341 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Stylianos Kandarakis Alexandros P Papadopoulos Georgios Roussopoulos Eustathios Georgopoulos Youngsik Chung Leonidas Doumazos Areum Baek Nefeli Ioanna Paizi Hyunik Shin Pantelis A Papadopoulos Source Type: research
Drug safety in Africa: a review of systems and resources for pharmacovigilance
Expert Opin Drug Saf. 2023 Sep 7:1-5. doi: 10.1080/14740338.2023.2251375. Online ahead of print.ABSTRACTINTRODUCTION: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.AREAS COVERED: This was an ...
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Helen Byomire Ndagije David Walusimbi Joanita Atuhaire Sheila Ampaire Source Type: research
COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan ®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
CONCLUSIONS: YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.PMID:37674345 | DOI:10.1080/14740338.2023.2252341 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Stylianos Kandarakis Alexandros P Papadopoulos Georgios Roussopoulos Eustathios Georgopoulos Youngsik Chung Leonidas Doumazos Areum Baek Nefeli Ioanna Paizi Hyunik Shin Pantelis A Papadopoulos Source Type: research
Drug safety in Africa: a review of systems and resources for pharmacovigilance
Expert Opin Drug Saf. 2023 Sep 7:1-5. doi: 10.1080/14740338.2023.2251375. Online ahead of print.ABSTRACTINTRODUCTION: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.AREAS COVERED: This was an ...
Source: Expert Opinion on Drug Safety - September 7, 2023 Category: Drugs & Pharmacology Authors: Helen Byomire Ndagije David Walusimbi Joanita Atuhaire Sheila Ampaire Source Type: research
