Improving the data quality of spontaneous ADR reports: a practical example from Malta
CONCLUSIONS: The implementation of such activities is expected to contribute to the overall pharmacovigilance systems in Malta and our experience could benefit other entities involved in spontaneous ADR reporting.PMID:34649475 | DOI:10.1080/14740338.2022.1993820 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 15, 2021 Category: Drugs & Pharmacology Authors: Marta Zuccarelli Benjamin Micallef Dianne Butler Anthony Serracino-Inglott John-Joseph Borg Source Type: research

An update on the safety of insulin-GLP-1 receptor agonist combinations in type 2 diabetes mellitus
Expert Opin Drug Saf. 2021 Oct 13:1-13. doi: 10.1080/14740338.2021.1978974. Online ahead of print.ABSTRACTINTRODUCTION: Recent development of novel antidiabetic drugs with proven cardiovascular (CV) and renal benefit and positive effect on body weight enable to take a more complex approach toward the management of type 2 diabetes mellitus (T2DM). Fixed-ratio combinations of insulin-GLP-1 receptor agonist (FRC) utilize complementary mechanisms of action of their individual components and address multiple pathologies linked with T2DM at the same time.AREAS COVERED: There are currently three FRCs on the market: iGlarLixi (gla...
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Peter Novodvorsk ý Martin Haluz ík Source Type: research

Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA Adverse Event Reporting System
CONCLUSION: Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and the risk of RD.PMID:34641748 | DOI:10.1080/14740338.2022.1993187 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Mohamed Kadry Taher Abdallah Alami Christopher A Gravel Derek Tsui Lise M Bjerre Franco Momoli Donald Mattison Daniel Krewski Source Type: research

Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma
Expert Opin Drug Saf. 2021 Oct 13. doi: 10.1080/14740338.2022.1993819. Online ahead of print.ABSTRACTINTRODUCTION: Cutaneous squamous cell carcinoma (CSCC) is the second most frequent malignant skin cancer, with an increasing worldwide incidence. Cemiplimab is a human monoclonal antibody directed against programmed cell death-1 receptor that acts by blocking T-cell inactivation. It is the first drug approved for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.AREAS COVERED: The aim of this review is to an...
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Alessia Villani Sonia Sofia Ocampo-Garza Luca Potestio Gabriella Fabbrocini Jorge Ocampo-Candiani Jorge Ocampo-Garza Massimiliano Scalvenzi Source Type: research

An update on the safety of insulin-GLP-1 receptor agonist combinations in type 2 diabetes mellitus
Expert Opin Drug Saf. 2021 Oct 13:1-13. doi: 10.1080/14740338.2021.1978974. Online ahead of print.ABSTRACTINTRODUCTION: Recent development of novel antidiabetic drugs with proven cardiovascular (CV) and renal benefit and positive effect on body weight enable to take a more complex approach toward the management of type 2 diabetes mellitus (T2DM). Fixed-ratio combinations of insulin-GLP-1 receptor agonist (FRC) utilize complementary mechanisms of action of their individual components and address multiple pathologies linked with T2DM at the same time.AREAS COVERED: There are currently three FRCs on the market: iGlarLixi (gla...
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Peter Novodvorsk ý Martin Haluz ík Source Type: research

Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA Adverse Event Reporting System
CONCLUSION: Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and the risk of RD.PMID:34641748 | DOI:10.1080/14740338.2022.1993187 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Mohamed Kadry Taher Abdallah Alami Christopher A Gravel Derek Tsui Lise M Bjerre Franco Momoli Donald Mattison Daniel Krewski Source Type: research

Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma
Expert Opin Drug Saf. 2021 Oct 13. doi: 10.1080/14740338.2022.1993819. Online ahead of print.ABSTRACTINTRODUCTION: Cutaneous squamous cell carcinoma (CSCC) is the second most frequent malignant skin cancer, with an increasing worldwide incidence. Cemiplimab is a human monoclonal antibody directed against programmed cell death-1 receptor that acts by blocking T-cell inactivation. It is the first drug approved for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.AREAS COVERED: The aim of this review is to an...
Source: Expert Opinion on Drug Safety - October 13, 2021 Category: Drugs & Pharmacology Authors: Alessia Villani Sonia Sofia Ocampo-Garza Luca Potestio Gabriella Fabbrocini Jorge Ocampo-Candiani Jorge Ocampo-Garza Massimiliano Scalvenzi Source Type: research

Safety evaluation of current therapies for high risk severely-ill patients with carbapenem-resistant infections
Expert Opin Drug Saf. 2021 Oct 9. doi: 10.1080/14740338.2022.1990262. Online ahead of print.ABSTRACTINTRODUCTION: Infections due to carbapenem resistant gram-negative bacteria (CR-GNB) are an increasingly frequent events, that are associated with high mortality rate. Traditionally, combination regimens including high doses of "old antibiotics" such as polymyxins, tigecycline and aminoglycosides have been used to treat these infections, but they were often associated with low efficacy and high excess of side effects and toxicity, especially nephrotoxicity. Along with the development of new compounds, the last deca...
Source: Expert Opinion on Drug Safety - October 11, 2021 Category: Drugs & Pharmacology Authors: Matteo Bassetti Antonio Falletta Giovanni Cenderello Daniele R Giacobbe Antonio Vena Source Type: research

Thalidomide: history, withdrawal, renaissance and safety concerns
Expert Opin Drug Saf. 2021 Oct 8. doi: 10.1080/14740338.2021.1991307. Online ahead of print.NO ABSTRACTPMID:34623196 | DOI:10.1080/14740338.2021.1991307 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 8, 2021 Category: Drugs & Pharmacology Authors: Neil Vargesson Trent Stephens Source Type: research

What should clinicians know about the renal effect and the mechanism of action of levosimendan?
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2021.1986483. Online ahead of print.NO ABSTRACTPMID:34612116 | DOI:10.1080/14740338.2021.1986483 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Patrick M Honore Sebastien Redant Sofie Moorthamers Thierry Preseau Keitiane Kaefer Leonel Barreto Gutierrez Rachid Attou Andrea Gallerani Willem Boer David De Bels Source Type: research

Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2022.1989409. Online ahead of print.ABSTRACTINTRODUCTION: Uterine fibroids (UFs) are the most prevalent benign neoplastic threat originating from myometria of reproductive age women, with profound financial load valued in hundreds of billions of dollars. Unfortunately, there is no curative treatment so far except surgery and available pharmacological treatments are restricted for short-term treatment options. Thus, there is a large unmet need in the UF space for noninvasive therapeutics.AREAS COVERED: Authors reviewed literature available for the utility of gonadotrop...
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Mohamed Ali Mohamed Raslan Micha ł Ciebiera Kornelia Zar ęba Ayman Al-Hendy Source Type: research

What should clinicians know about the renal effect and the mechanism of action of levosimendan?
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2021.1986483. Online ahead of print.NO ABSTRACTPMID:34612116 | DOI:10.1080/14740338.2021.1986483 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Patrick M Honore Sebastien Redant Sofie Moorthamers Thierry Preseau Keitiane Kaefer Leonel Barreto Gutierrez Rachid Attou Andrea Gallerani Willem Boer David De Bels Source Type: research

Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2022.1989409. Online ahead of print.ABSTRACTINTRODUCTION: Uterine fibroids (UFs) are the most prevalent benign neoplastic threat originating from myometria of reproductive age women, with profound financial load valued in hundreds of billions of dollars. Unfortunately, there is no curative treatment so far except surgery and available pharmacological treatments are restricted for short-term treatment options. Thus, there is a large unmet need in the UF space for noninvasive therapeutics.AREAS COVERED: Authors reviewed literature available for the utility of gonadotrop...
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Mohamed Ali Mohamed Raslan Micha ł Ciebiera Kornelia Zar ęba Ayman Al-Hendy Source Type: research

What should clinicians know about the renal effect and the mechanism of action of levosimendan?
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2021.1986483. Online ahead of print.NO ABSTRACTPMID:34612116 | DOI:10.1080/14740338.2021.1986483 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Patrick M Honore Sebastien Redant Sofie Moorthamers Thierry Preseau Keitiane Kaefer Leonel Barreto Gutierrez Rachid Attou Andrea Gallerani Willem Boer David De Bels Source Type: research

Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2022.1989409. Online ahead of print.ABSTRACTINTRODUCTION: Uterine fibroids (UFs) are the most prevalent benign neoplastic threat originating from myometria of reproductive age women, with profound financial load valued in hundreds of billions of dollars. Unfortunately, there is no curative treatment so far except surgery and available pharmacological treatments are restricted for short-term treatment options. Thus, there is a large unmet need in the UF space for noninvasive therapeutics.AREAS COVERED: Authors reviewed literature available for the utility of gonadotrop...
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Mohamed Ali Mohamed Raslan Micha ł Ciebiera Kornelia Zar ęba Ayman Al-Hendy Source Type: research

Dermatologic adverse events associated with targeted therapies for melanoma
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1986000. Online ahead of print.ABSTRACTINTRODUCTION: The development of new targeted therapies has considerably changed the therapeutic paradigm of melanoma, significantly increasing overall survival (OS) and progression free survival (PFS). However, skin-related adverse sequelae might occur and impact on patients' quality of life.AREAS COVERED: In this article we will cover the most important dermatological toxicities related to BRAF and MEK-inhibitors, along with updated management strategies.EXPERT OPINION: BRAF inhibitors have represented a revolution in the ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Luigi Scarpato Lucia Festino Vito Vanella Gabriele Madonna Massimo Mastroianni Marco Palla Paolo Antonio Ascierto Source Type: research

Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988568. Online ahead of print.ABSTRACTINTRODUCTION: : Inclisiran is a novel post-transcriptional gene silencing therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by RNA interference, and has a potent, dose-dependent, durable effect in lowering LDL-C, and therefore is an effective drug to treat dyslipidemia, reducing the risk for acute cardiovascular (CV) events. It is safe and well-tolerated.AREAS COVERED: : This paper aims to review the mechanism of action inclisiran while evaluating its efficacy and safety in the treatment o...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Yajnavalka Banerjee Anca Pantea Stoian Arrigo Francesco Giuseppe Cicero Federica Fogacci Dragana Nikolic Alexandros Sachinidis Ali A Rizvi Andrej Janez Manfredi Rizzo Source Type: research

Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for Parkinson's disease
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988926. Online ahead of print.ABSTRACTINTRODUCTION: While levodopa is still the most effective treatment for Parkinson's disease, concerns about long-term complications such as wearing-off and dyskinesia with levodopa usage remain.AREAS COVERED: : Safinamide is a highly selective and reversible monoamine oxidase B inhibitor introduced in the European Union, Japan, and the United States as an adjunctive agent to levodopa in PD patients with motor fluctuation. This review outlines the pharmacological properties, therapeutic effects, and tolerability of safinamide ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Kanako Kurihara Takayasu Mishima Shinsuke Fujioka Yoshio Tsuboi Source Type: research

Dermatologic adverse events associated with targeted therapies for melanoma
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1986000. Online ahead of print.ABSTRACTINTRODUCTION: The development of new targeted therapies has considerably changed the therapeutic paradigm of melanoma, significantly increasing overall survival (OS) and progression free survival (PFS). However, skin-related adverse sequelae might occur and impact on patients' quality of life.AREAS COVERED: In this article we will cover the most important dermatological toxicities related to BRAF and MEK-inhibitors, along with updated management strategies.EXPERT OPINION: BRAF inhibitors have represented a revolution in the ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Luigi Scarpato Lucia Festino Vito Vanella Gabriele Madonna Massimo Mastroianni Marco Palla Paolo Antonio Ascierto Source Type: research

Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988568. Online ahead of print.ABSTRACTINTRODUCTION: : Inclisiran is a novel post-transcriptional gene silencing therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by RNA interference, and has a potent, dose-dependent, durable effect in lowering LDL-C, and therefore is an effective drug to treat dyslipidemia, reducing the risk for acute cardiovascular (CV) events. It is safe and well-tolerated.AREAS COVERED: : This paper aims to review the mechanism of action inclisiran while evaluating its efficacy and safety in the treatment o...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Yajnavalka Banerjee Anca Pantea Stoian Arrigo Francesco Giuseppe Cicero Federica Fogacci Dragana Nikolic Alexandros Sachinidis Ali A Rizvi Andrej Janez Manfredi Rizzo Source Type: research

Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for Parkinson's disease
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988926. Online ahead of print.ABSTRACTINTRODUCTION: While levodopa is still the most effective treatment for Parkinson's disease, concerns about long-term complications such as wearing-off and dyskinesia with levodopa usage remain.AREAS COVERED: : Safinamide is a highly selective and reversible monoamine oxidase B inhibitor introduced in the European Union, Japan, and the United States as an adjunctive agent to levodopa in PD patients with motor fluctuation. This review outlines the pharmacological properties, therapeutic effects, and tolerability of safinamide ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Kanako Kurihara Takayasu Mishima Shinsuke Fujioka Yoshio Tsuboi Source Type: research

Dermatologic adverse events associated with targeted therapies for melanoma
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1986000. Online ahead of print.ABSTRACTINTRODUCTION: The development of new targeted therapies has considerably changed the therapeutic paradigm of melanoma, significantly increasing overall survival (OS) and progression free survival (PFS). However, skin-related adverse sequelae might occur and impact on patients' quality of life.AREAS COVERED: In this article we will cover the most important dermatological toxicities related to BRAF and MEK-inhibitors, along with updated management strategies.EXPERT OPINION: BRAF inhibitors have represented a revolution in the ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Luigi Scarpato Lucia Festino Vito Vanella Gabriele Madonna Massimo Mastroianni Marco Palla Paolo Antonio Ascierto Source Type: research

Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988568. Online ahead of print.ABSTRACTINTRODUCTION: : Inclisiran is a novel post-transcriptional gene silencing therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by RNA interference, and has a potent, dose-dependent, durable effect in lowering LDL-C, and therefore is an effective drug to treat dyslipidemia, reducing the risk for acute cardiovascular (CV) events. It is safe and well-tolerated.AREAS COVERED: : This paper aims to review the mechanism of action inclisiran while evaluating its efficacy and safety in the treatment o...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Yajnavalka Banerjee Anca Pantea Stoian Arrigo Francesco Giuseppe Cicero Federica Fogacci Dragana Nikolic Alexandros Sachinidis Ali A Rizvi Andrej Janez Manfredi Rizzo Source Type: research

Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for Parkinson's disease
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988926. Online ahead of print.ABSTRACTINTRODUCTION: While levodopa is still the most effective treatment for Parkinson's disease, concerns about long-term complications such as wearing-off and dyskinesia with levodopa usage remain.AREAS COVERED: : Safinamide is a highly selective and reversible monoamine oxidase B inhibitor introduced in the European Union, Japan, and the United States as an adjunctive agent to levodopa in PD patients with motor fluctuation. This review outlines the pharmacological properties, therapeutic effects, and tolerability of safinamide ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Kanako Kurihara Takayasu Mishima Shinsuke Fujioka Yoshio Tsuboi Source Type: research

Dermatologic adverse events associated with targeted therapies for melanoma
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1986000. Online ahead of print.ABSTRACTINTRODUCTION: The development of new targeted therapies has considerably changed the therapeutic paradigm of melanoma, significantly increasing overall survival (OS) and progression free survival (PFS). However, skin-related adverse sequelae might occur and impact on patients' quality of life.AREAS COVERED: In this article we will cover the most important dermatological toxicities related to BRAF and MEK-inhibitors, along with updated management strategies.EXPERT OPINION: BRAF inhibitors have represented a revolution in the ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Luigi Scarpato Lucia Festino Vito Vanella Gabriele Madonna Massimo Mastroianni Marco Palla Paolo Antonio Ascierto Source Type: research

Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988568. Online ahead of print.ABSTRACTINTRODUCTION: : Inclisiran is a novel post-transcriptional gene silencing therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by RNA interference, and has a potent, dose-dependent, durable effect in lowering LDL-C, and therefore is an effective drug to treat dyslipidemia, reducing the risk for acute cardiovascular (CV) events. It is safe and well-tolerated.AREAS COVERED: : This paper aims to review the mechanism of action inclisiran while evaluating its efficacy and safety in the treatment o...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Yajnavalka Banerjee Anca Pantea Stoian Arrigo Francesco Giuseppe Cicero Federica Fogacci Dragana Nikolic Alexandros Sachinidis Ali A Rizvi Andrej Janez Manfredi Rizzo Source Type: research

Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for Parkinson's disease
Expert Opin Drug Saf. 2021 Oct 1. doi: 10.1080/14740338.2022.1988926. Online ahead of print.ABSTRACTINTRODUCTION: While levodopa is still the most effective treatment for Parkinson's disease, concerns about long-term complications such as wearing-off and dyskinesia with levodopa usage remain.AREAS COVERED: : Safinamide is a highly selective and reversible monoamine oxidase B inhibitor introduced in the European Union, Japan, and the United States as an adjunctive agent to levodopa in PD patients with motor fluctuation. This review outlines the pharmacological properties, therapeutic effects, and tolerability of safinamide ...
Source: Expert Opinion on Drug Safety - October 1, 2021 Category: Drugs & Pharmacology Authors: Kanako Kurihara Takayasu Mishima Shinsuke Fujioka Yoshio Tsuboi Source Type: research

Reply to the article 'Investigating the root cause of N- nitrosodimethylamine formation in metformin pharmaceutical products'
Expert Opin Drug Saf. 2021 Sep 29:1. doi: 10.1080/14740338.2021.1983310. Online ahead of print.NO ABSTRACTPMID:34587843 | DOI:10.1080/14740338.2021.1983310 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 30, 2021 Category: Drugs & Pharmacology Authors: Markus Mintert Michael Kerry Dean Lee June Zhu Koudi Zhu Barbara Serr Mark Dreibelbis Elizabeth Tocce Meinolf Brackhagen Source Type: research

Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data
Conclusions:Although it is not able to confirm the casual relationship between VTE and CDK4/6 inhibitors, this study suggested signal of VTE reporting in patients receiving CDK4/6 inhibitors, which is likely to reflect a potential association. The results may enhance physicians' awareness of the potential side effect of VTE associated with CDK 4/6 inhibitors. An early recognition of VTE signs/symptoms could decrease the morbidity and severity of such adverse events.PMID:34581647 | DOI:10.1080/14740338.2021.1981856 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 28, 2021 Category: Drugs & Pharmacology Authors: Ming-Ming Yan Shu-Shan Wu Yu-Peng Qi Zi-Ran Li Qian Zhang Hui Zhao Ming-Kang Zhong Xiao-Yan Qiu Source Type: research

Safety considerations for prescribing SSRI antidepressants to patients at increased cardiovascular risk
Expert Opin Drug Saf. 2021 Sep 27. doi: 10.1080/14740338.2022.1986001. Online ahead of print.ABSTRACTINTRODUCTION: With the development of selective serotonin reuptake inhibitors (SSRI), a relatively uncomplicated treatment of depression and a safer alternative to tricyclic antidepressants was introduced. Any medical treatment has potential safety risks, however, and these risks should also be considered when prescribing SSRIs.AREAS COVERED: The present review focuses on safety considerations when prescribing SSRIs to patients with previous stroke and myocardial infarction, as depression, and the need for antidepressant tr...
Source: Expert Opinion on Drug Safety - September 27, 2021 Category: Drugs & Pharmacology Authors: Janne Kaergaard Mortensen Grethe Andersen Source Type: research

Breast cancer treatment-related cardiovascular disturbances: advocacy for a watchful attitude in this never-ending story
Expert Opin Drug Saf. 2021 Sep 22. doi: 10.1080/14740338.2021.1983541. Online ahead of print.ABSTRACTINTRODUCTION: Thanks to the emergence of new therapeutics, prognosis and outcome of breast cancer patients (any subtype) have improved significantly. This raises the issue of the interactions and side effects related to the use of multiple drugs. Thus, to decide on a treatment the optimal benefit risk-ratio should be carefully watched as toxicities such as cardiac ones effect on long-term survival. Indeed, nowadays in France, cardiovascular diseases rank first as causes of death in women.AREAS COVERED: This non-exhaustive r...
Source: Expert Opinion on Drug Safety - September 23, 2021 Category: Drugs & Pharmacology Authors: Charl ène Rivier Benoite Mery Elise Rowinski Sandrine Sotton Wafa Bouleftour Laurent Bertoletti Olivier Tredan Nicolas Magne Source Type: research

Investigating the Root Cause of N-nitrosodimethylamine Formation in Metformin Pharmaceutical Products
Expert Opin Drug Saf. 2021 Sep 21. doi: 10.1080/14740338.2021.1983312. Online ahead of print.NO ABSTRACTPMID:34546846 | DOI:10.1080/14740338.2021.1983312 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 21, 2021 Category: Drugs & Pharmacology Authors: Nasr Eldin Hussein Nasr Metwaly Gamel Metwaly Eman Osama Ahmed Ahmed Roshdy Fares Aliaa Nabil ElMeshad Source Type: research

New approaches to antipsychotic medication adherence - safety, tolerability and acceptability
Expert Opin Drug Saf. 2021 Sep 19. doi: 10.1080/14740338.2021.1983540. Online ahead of print.ABSTRACTINTRODUCTION: Antipsychotic pharmacotherapy is considered first-line treatment in schizophrenia-related disorders and is associated with favorable prognosis and lower mortality rates. However, low adherence rates present a major clinical challenge. In this paper we will review contemporary approaches to improve adherence to antipsychotic treatment, considering their mechanism of action, safety, tolerability and acceptability.AREAS COVERED: Novel pharmacological delivery methods such as different routes of administration of ...
Source: Expert Opinion on Drug Safety - September 20, 2021 Category: Drugs & Pharmacology Authors: Sharon Taub Amir Krivoy Eromona Whiskey Sukhi S Shergill Source Type: research

Monitoring and safety of CAR-T therapy in clinical practice
Expert Opin Drug Saf. 2021 Sep 14. doi: 10.1080/14740338.2021.1979958. Online ahead of print.ABSTRACTINTRODUCTION: : In the last few years, a new T cell therapy, chimeric antigen receptor-T (CAR-T) cells, has been developed. CAR-T cells are highly effective at inhibiting antitumor activity, but they can cause a wide spectrum of unusual side effects.AREAS COVERED: : The present review provides an overview of the adverse events of CAR-T cell therapy, focusing on cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, increased risk of infections, and other long-term complications. Representative st...
Source: Expert Opinion on Drug Safety - September 14, 2021 Category: Drugs & Pharmacology Authors: Jos é M Serra López-Matencio Valle G ómez de Soria Manuel G ómez Estefan ía Alañón-Plaza Cecilia Mu ñoz-Calleja Santos Casta ñeda Source Type: research