Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research
Expert Opin Drug Saf. 2021 Jul 27:1-10. doi: 10.1080/14740338.2021.1957829. Online ahead of print.ABSTRACTINTRODUCTION: It is generally acknowledged that the ocular safety profile of intravitreal anti-VEGF drugs is acceptable, while the burden of systemic safety of these intravitreal agents is still being debated. The evaluation of the systemic safety of these drugs using real-world data (RWD), such as spontaneous reporting systems (SRS), electronic medical records (EMRs) and claims databases has several advantages, including the capture of outcomes among real-world populations over long observation periods. Nevertheless, ...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Giulia Scondotto Salvatore Crisafulli Ippazio Cosimo Antonazzo Gianni Virgili Gianluca Trifir ò Janet Sultana Source Type: research

Gastroenterological safety of IL-17 inhibitors: a systematic literature review
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1960981. Online ahead of print.ABSTRACTINTRODUCTION: Interleukin 17 is a proinflammatory cytokine considered to play a significant role in the immunopathogenesis of many chronic immune-mediated disorders. Interleukin 17 inhibitors provide an excellent treatment option for patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. However, Interleukin 17 inhibitors have been suspected of worsening or triggering new-onset inflammatory bowel disease.AREAS COVERED: A literature search was conducted until March 2021 to investigate reporting prevalence, ...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: B énédicte Caron Jean-Yves Jouzeau Pierre Miossec Nadine Petitpain Pierre Gillet Patrick Netter Laurent Peyrin-Biroulet Source Type: research

Safety of non-hormonal medications for managing hot flashes
Expert Opin Drug Saf. 2021 Jul 28:1-7. doi: 10.1080/14740338.2021.1960310. Online ahead of print.ABSTRACTIntroduction: Menopausal complaints are a critical aspect of women's lives. In particular vasomotor symptoms, such as hot flashes, may seriously impact quality of life and are considered the most bothersome complaint by patients. Although Menopausal Hormone Therapy (MHT) is considered the best option, women increasingly ask for a natural and more tailored treatment approach.Areas covered: Nutraceutical compounds represent the most widespread alternative therapy for vasomotor symptoms, and their use is somewhat increasin...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Pasquale De Franciscis Maurizio Guida Antonio Schiattarella Gaetano Riemma Nicola Colacurci Source Type: research

Update on infective complications in patients treated with alemtuzumab for multiple sclerosis: review and meta-analysis of real-world and randomized studies
CONCLUSIONS: Clinicians should be aware that the prevalence of serious infections during alemtuzumab can be higher than expected from RCTs. Peculiar opportunistic infections should be considered when evaluating a patient treated with alemtuzumab who develops signs of infection.PMID:34310251 | DOI:10.1080/14740338.2021.1942454 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Antonio Riccardo Buonomo Giulio Viceconte Emanuela Zappulo Alberto Enrico Maraolo Cinzia Valeria Russo Antonio Carotenuto Marcello Moccia Ivan Gentile Source Type: research

Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1957829. Online ahead of print.ABSTRACTINTRODUCTION: It is generally acknowledged that the ocular safety profile of intravitreal anti-VEGF drugs is acceptable, while the burden of systemic safety of these intravitreal agents is still being debated. The evaluation of the systemic safety of these drugs using real-world data (RWD), such as spontaneous reporting systems (SRS), electronic medical records (EMRs) and claims databases has several advantages, including the capture of outcomes among real-world populations over long observational periods. Nevertheless, the...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Giulia Scondotto Salvatore Crisafulli Ippazio Cosimo Antonazzo Gianni Virgili Gianluca Trifir ò Janet Sultana Source Type: research

Gastroenterological safety of IL-17 inhibitors: a systematic literature review
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1960981. Online ahead of print.ABSTRACTINTRODUCTION: Interleukin 17 is a proinflammatory cytokine considered to play a significant role in the immunopathogenesis of many chronic immune-mediated disorders. Interleukin 17 inhibitors provide an excellent treatment option for patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. However, Interleukin 17 inhibitors have been suspected of worsening or triggering new-onset inflammatory bowel disease.AREAS COVERED: A literature search was conducted until March 2021 to investigate reporting prevalence, ...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: B énédicte Caron Jean-Yves Jouzeau Pierre Miossec Nadine Petitpain Pierre Gillet Patrick Netter Laurent Peyrin-Biroulet Source Type: research

Safety of non-hormonal medications for managing hot flashes
Expert Opin Drug Saf. 2021 Jul 28:1-7. doi: 10.1080/14740338.2021.1960310. Online ahead of print.ABSTRACTIntroduction: Menopausal complaints are a critical aspect of women's lives. In particular vasomotor symptoms, such as hot flashes, may seriously impact quality of life and are considered the most bothersome complaint by patients. Although Menopausal Hormone Therapy (MHT) is considered the best option, women increasingly ask for a natural and more tailored treatment approach.Areas covered: Nutraceutical compounds represent the most widespread alternative therapy for vasomotor symptoms, and their use is somewhat increasin...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Pasquale De Franciscis Maurizio Guida Antonio Schiattarella Gaetano Riemma Nicola Colacurci Source Type: research

Update on infective complications in patients treated with alemtuzumab for multiple sclerosis: review and meta-analysis of real-world and randomized studies
CONCLUSIONS: Clinicians should be aware that the prevalence of serious infections during alemtuzumab can be higher than expected from RCTs. Peculiar opportunistic infections should be considered when evaluating a patient treated with alemtuzumab who develops signs of infection.PMID:34310251 | DOI:10.1080/14740338.2021.1942454 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Antonio Riccardo Buonomo Giulio Viceconte Emanuela Zappulo Alberto Enrico Maraolo Cinzia Valeria Russo Antonio Carotenuto Marcello Moccia Ivan Gentile Source Type: research

Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1957829. Online ahead of print.ABSTRACTINTRODUCTION: It is generally acknowledged that the ocular safety profile of intravitreal anti-VEGF drugs is acceptable, while the burden of systemic safety of these intravitreal agents is still being debated. The evaluation of the systemic safety of these drugs using real-world data (RWD), such as spontaneous reporting systems (SRS), electronic medical records (EMRs) and claims databases has several advantages, including the capture of outcomes among real-world populations over long observational periods. Nevertheless, the...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Giulia Scondotto Salvatore Crisafulli Ippazio Cosimo Antonazzo Gianni Virgili Gianluca Trifir ò Janet Sultana Source Type: research

Gastroenterological safety of IL-17 inhibitors: a systematic literature review
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1960981. Online ahead of print.ABSTRACTINTRODUCTION: Interleukin 17 is a proinflammatory cytokine considered to play a significant role in the immunopathogenesis of many chronic immune-mediated disorders. Interleukin 17 inhibitors provide an excellent treatment option for patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. However, Interleukin 17 inhibitors have been suspected of worsening or triggering new-onset inflammatory bowel disease.AREAS COVERED: A literature search was conducted until March 2021 to investigate reporting prevalence, ...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: B énédicte Caron Jean-Yves Jouzeau Pierre Miossec Nadine Petitpain Pierre Gillet Patrick Netter Laurent Peyrin-Biroulet Source Type: research

Safety of non-hormonal medications for managing hot flashes
Expert Opin Drug Saf. 2021 Jul 26. doi: 10.1080/14740338.2021.1960310. Online ahead of print.ABSTRACTINTRODUCTION: Menopausal complaints are a critical aspect of women's lives. In particular vasomotor symptoms, such as hot flashes, may seriously impact quality of life and are considered the most bothersome complaint by patients. Although Menopausal Hormone Therapy (MHT) is considered the best option, women increasingly ask for a natural and more tailored treatment approach.AREAS COVERED: Nutraceutical compounds represent the most widespread alternative therapy for vasomotor symptoms, and their use is somewhat increasing. I...
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Pasquale De Franciscis Maurizio Guida Antonio Schiattarella Gaetano Riemma Nicola Colacurci Source Type: research

Update on infective complications in patients treated with alemtuzumab for multiple sclerosis: review and meta-analysis of real-world and randomized studies
CONCLUSIONS: Clinicians should be aware that the prevalence of serious infections during alemtuzumab can be higher than expected from RCTs. Peculiar opportunistic infections should be considered when evaluating a patient treated with alemtuzumab who develops signs of infection.PMID:34310251 | DOI:10.1080/14740338.2021.1942454 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 26, 2021 Category: Drugs & Pharmacology Authors: Antonio Riccardo Buonomo Giulio Viceconte Emanuela Zappulo Alberto Enrico Maraolo Cinzia Valeria Russo Antonio Carotenuto Marcello Moccia Ivan Gentile Source Type: research

Safety of elobixibat and lubiprostone in Japanese patients with chronic constipation: a retrospective cohort study
CONCLUSION: No new safety concerns have been raised in relation to elobixibat and lubiprostone use for treating chronic constipation, although the HR of different events varied. Further larger-scale study is needed as the estimates for events of small numbers were unstable.PMID:34281471 | DOI:10.1080/14740338.2021.1952980 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 20, 2021 Category: Drugs & Pharmacology Authors: Nobuhiro Ooba Yoshinori Takahashi Marina Nagamura Masao Takahashi Makoto Ushida Eiji Kawakami Masaomi Kimura Tsugumichi Sato Junichi Tokuyoshi Choichiro Miyazaki Mitsuaki Shimada Source Type: research

Serious adverse events with tedizolid and linezolid: pharmacovigilance insights through the FDA adverse event reporting system
ConclusionsSimilar AE reporting between the two oxazolidinones was found. Considering limitations of pharmacovigilance, this hypothesis of comparable safety profile should be tested prospectively through dedicated real-world studies.PMID:34280062 | DOI:10.1080/14740338.2021.1956461 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 19, 2021 Category: Drugs & Pharmacology Authors: Milo Gatti Michele Fusaroli Emanuel Raschi Ugo Moretti Elisabetta Poluzzi Fabrizio De Ponti Source Type: research

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.PMID:34263667 | DOI:10.1080/14740338.2021.1952981 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Lourens T Bloem Mariana Karomi Jarno Hoekman Menno E van der Elst Hubert G M Leufkens Olaf H Klungel Aukje K Mantel-Teeuwisse Source Type: research

The safety of current treatment options for advanced oesophageal cancer after first-line chemotherapy
Expert Opin Drug Saf. 2021 Jul 15. doi: 10.1080/14740338.2021.1955100. Online ahead of print.ABSTRACTINTRODUCTION: The prognosis of advanced oesophageal cancer (EC) remains poor, and few effective agents are available. For advanced EC patients, a combination of platinum and fluoropyrimidine is recognized as the standard first-line treatment. After first-line treatment, taxane or irinotecan has been used. Based on the KEYNOTE-181 and the ATTRACTION-3 trials, immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab appear to prolong survival, compared with cytotoxic agents, as second-line treatments for advanc...
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Go Ikeda Shun Yamamoto Ken Kato Source Type: research

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines
CONCLUSION: Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.PMID:34264151 | DOI:10.1080/14740338.2021.1955101 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Maurizio Sessa Kristian Kragholm Anders Hviid Morten Andersen Source Type: research

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.PMID:34263667 | DOI:10.1080/14740338.2021.1952981 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Lourens T Bloem Mariana Karomi Jarno Hoekman Menno E van der Elst Hubert G M Leufkens Olaf H Klungel Aukje K Mantel-Teeuwisse Source Type: research

The safety of current treatment options for advanced oesophageal cancer after first-line chemotherapy
Expert Opin Drug Saf. 2021 Jul 15. doi: 10.1080/14740338.2021.1955100. Online ahead of print.ABSTRACTINTRODUCTION: The prognosis of advanced oesophageal cancer (EC) remains poor, and few effective agents are available. For advanced EC patients, a combination of platinum and fluoropyrimidine is recognized as the standard first-line treatment. After first-line treatment, taxane or irinotecan has been used. Based on the KEYNOTE-181 and the ATTRACTION-3 trials, immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab appear to prolong survival, compared with cytotoxic agents, as second-line treatments for advanc...
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Go Ikeda Shun Yamamoto Ken Kato Source Type: research

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines
CONCLUSION: Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.PMID:34264151 | DOI:10.1080/14740338.2021.1955101 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Maurizio Sessa Kristian Kragholm Anders Hviid Morten Andersen Source Type: research

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.PMID:34263667 | DOI:10.1080/14740338.2021.1952981 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Lourens T Bloem Mariana Karomi Jarno Hoekman Menno E van der Elst Hubert G M Leufkens Olaf H Klungel Aukje K Mantel-Teeuwisse Source Type: research

The safety of current treatment options for advanced oesophageal cancer after first-line chemotherapy
Expert Opin Drug Saf. 2021 Jul 15. doi: 10.1080/14740338.2021.1955100. Online ahead of print.ABSTRACTINTRODUCTION: The prognosis of advanced oesophageal cancer (EC) remains poor, and few effective agents are available. For advanced EC patients, a combination of platinum and fluoropyrimidine is recognized as the standard first-line treatment. After first-line treatment, taxane or irinotecan has been used. Based on the KEYNOTE-181 and the ATTRACTION-3 trials, immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab appear to prolong survival, compared with cytotoxic agents, as second-line treatments for advanc...
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Go Ikeda Shun Yamamoto Ken Kato Source Type: research

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines
CONCLUSION: Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.PMID:34264151 | DOI:10.1080/14740338.2021.1955101 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Maurizio Sessa Kristian Kragholm Anders Hviid Morten Andersen Source Type: research

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making.PMID:34263667 | DOI:10.1080/14740338.2021.1952981 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Lourens T Bloem Mariana Karomi Jarno Hoekman Menno E van der Elst Hubert G M Leufkens Olaf H Klungel Aukje K Mantel-Teeuwisse Source Type: research

The safety of current treatment options for advanced oesophageal cancer after first-line chemotherapy
Expert Opin Drug Saf. 2021 Jul 15. doi: 10.1080/14740338.2021.1955100. Online ahead of print.ABSTRACTINTRODUCTION: The prognosis of advanced oesophageal cancer (EC) remains poor, and few effective agents are available. For advanced EC patients, a combination of platinum and fluoropyrimidine is recognized as the standard first-line treatment. After first-line treatment, taxane or irinotecan has been used. Based on the KEYNOTE-181 and the ATTRACTION-3 trials, immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab appear to prolong survival, compared with cytotoxic agents, as second-line treatments for advanc...
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Go Ikeda Shun Yamamoto Ken Kato Source Type: research

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines
CONCLUSION: Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.PMID:34264151 | DOI:10.1080/14740338.2021.1955101 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 15, 2021 Category: Drugs & Pharmacology Authors: Maurizio Sessa Kristian Kragholm Anders Hviid Morten Andersen Source Type: research

Safety profile of D-penicillamine: a comprehensive pharmacovigilance analysis by FDA adverse event reporting system
CONCLUSIONS: Patients taking D-pen require close monitoring of renal function, blood counts, immunity, liver, cardiac function, and neurological function. D-pen suppresses immune system which maximizes the risk of infection.PMID:34259127 | DOI:10.1080/14740338.2021.1956460 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 14, 2021 Category: Drugs & Pharmacology Authors: Vijay Kumar Anand Prakash Singh Nicholas Wheeler Cristi L Galindo Jong-Joo Kim Source Type: research

Safety considerations with new antibacterial approaches for chronic bacterial prostatitis
Expert Opin Drug Saf. 2021 Jul 14. doi: 10.1080/14740338.2021.1956459. Online ahead of print.ABSTRACTChronic bacterial prostatitis (CBP) is a difficult-to-eradicate infection. Antibacterial therapy with currently licensed agents is hindered due to the increasing emergence of pathogen resistance worldwide and to frequent infection relapse. With limited treatment options, physicians are investigating new agents, which however may raise safety concerns.Areas covered: Antibacterial agents currently licensed for CBP were not considered. Available reports about safety and efficacy of antibacterial agents that have been clinicall...
Source: Expert Opinion on Drug Safety - July 14, 2021 Category: Drugs & Pharmacology Authors: Gianpaolo Perletti Alberto Trinchieri Konstantinos Stamatiou Vittorio Magri Source Type: research

Safety profile of D-penicillamine: a comprehensive pharmacovigilance analysis by FDA adverse event reporting system
CONCLUSIONS: Patients taking D-pen require close monitoring of renal function, blood counts, immunity, liver, cardiac function, and neurological function. D-pen suppresses immune system which maximizes the risk of infection.PMID:34259127 | DOI:10.1080/14740338.2021.1956460 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 14, 2021 Category: Drugs & Pharmacology Authors: Vijay Kumar Anand Prakash Singh Nicholas Wheeler Cristi L Galindo Jong-Joo Kim Source Type: research

Icosapent ethyl: safely reducing cardiovascular risk in adults with elevated triglycerides
Expert Opin Drug Saf. 2021 Jul 12. doi: 10.1080/14740338.2021.1954158. Online ahead of print.ABSTRACTINTRODUCTION: In patients at high cardiovascular risk, the rate of events remains elevated despite traditional, evidence-based lipid-lowering therapy. Residual hypertriglyceridemia is an important contributor to this risk. However, prior medications with triglyceride-lowering effects have not demonstrated an ability to reduce adverse clinical outcomes in the statin era.AREAS COVERED: The present review summarizes evidence and recommendations related to triglyceride-lowering therapy in the primary and secondary preventive se...
Source: Expert Opinion on Drug Safety - July 13, 2021 Category: Drugs & Pharmacology Authors: Manan Pareek R Preston Mason Deepak L Bhatt Source Type: research

Safety of treating acute liver injury and failure
Expert Opin Drug Saf. 2021 Jul 13. doi: 10.1080/14740338.2021.1955854. Online ahead of print.ABSTRACTAcute liver injury and progression to acute liver failure can be life-threatening conditions that require prompt careful clinical assessment and therapeutic management.Areas covered: The aim of this article is to review the safety and side effect profile of pharmacological therapies used in the treatment of acute liver injury with specific focus on hepatic toxicity. We performed an extensive literature search with the terms "acute liver injury", "acute liver failure", "therapy", "safety&qu...
Source: Expert Opinion on Drug Safety - July 13, 2021 Category: Drugs & Pharmacology Authors: Miren Garc ía-Cortés Aida Ortega-Alonso Ra úl J Andrade Source Type: research

A systematic review on pediatric medication errors by parents or caregivers at home
This study aimed to review the current literature on the frequency of pediatric MEs by parents or caregivers at home, their associated factors, and pediatric ME reporting systems. Citable original articles of any type of study design or reviews published from 2013 to 2021 were searched in Medline, Scopus, Embase, and ScienceDirect databases.Expert opinion: The available data about the frequency of pediatric MEs at home varied from 30% to 80%. Current research suggests the risk of making a ME in pediatric patients at home may depend on the characteristics of the caregiver and may increase if a prescription contains ≥3 dr...
Source: Expert Opinion on Drug Safety - July 12, 2021 Category: Drugs & Pharmacology Authors: Adriana Lopez-Pineda Javier Gonzalez de Dios Mercedes Guilabert Mora Gema Mira-Perceval Juan Jose Joaqu ín Mira Solves Source Type: research

Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?
Expert Opin Drug Saf. 2021 Jul 7. doi: 10.1080/14740338.2021.1953467. Online ahead of print.ABSTRACTINTRODUCTION: One of the biggest drug disasters in history has not prevented thalidomide from being used to treat various clinical conditions. Currently, Brazil has a worrying scenario: high consumption of the drug and, cases of pregnant women using thalidomide, even after adopting restrictive legislation.AREAS COVERED: This review of the literature and legislation sought to comparatively analyze the monitoring of thalidomide use in Brazil and other countries that use this drug. Finally, we discuss the differences between th...
Source: Expert Opinion on Drug Safety - July 7, 2021 Category: Drugs & Pharmacology Authors: Soraya Machado de Jesus Rafael Santos Santana Silvana Nair Leite Source Type: research

A cross-sectional survey of hospitalization and blood tests implementation status in patients who received tolvaptan under 75 years of age using a Japanese claims database
Expert Opin Drug Saf. 2021 Jul 6. doi: 10.1080/14740338.2021.1951219. Online ahead of print.ABSTRACTBACKGROUND: Hypernatremia and liver injury are typical adverse effects of tolvaptan. Therefore, hospitalization and frequent monitoring of serum sodium concentration and liver function are necessary for tolvaptan initiation. We performed a cross-sectional survey to evaluate these situations.RESEARCH DESIGN AND METHODS: We employed the Japanese claims database, which contains data of patients aged
Source: Expert Opinion on Drug Safety - July 6, 2021 Category: Drugs & Pharmacology Authors: Shungo Imai Kenji Momo Hitoshi Kashiwagi Yuki Sato Takayuki Miyai Mitsuru Sugawara Yoh Takekuma Source Type: research

Safety review of anti-VEGF therapy in patients with myopic choroidal neovascularization
Expert Opin Drug Saf. 2021 Jul 6. doi: 10.1080/14740338.2021.1952979. Online ahead of print.ABSTRACTINTRODUCTION: Anti-angiogenesis therapy with intravitreal anti-VEGF agents is now the standard-of-care treatment for myopic choroidal neovascularization (CNV).AREAS COVERED: We provide a critical review of the safety of all the anti-VEGF agents currently used for treating myopic CNV including ranibizumab, aflibercept, conbercept, bevacizumab and ziv-aflibercept.EXPERT OPINION: Anti-VEGF therapy for myopic CNV with the currently available anti-VEGF drugs generally have favorable safety outcomes in the short-term. Nonetheless,...
Source: Expert Opinion on Drug Safety - July 6, 2021 Category: Drugs & Pharmacology Authors: Danny S C Ng Mary Ho Lawrence P L Iu Timothy Y Y Lai Source Type: research

A cross-sectional survey of hospitalization and blood tests implementation status in patients who received tolvaptan under 75 years of age using a Japanese claims database
Expert Opin Drug Saf. 2021 Jul 6. doi: 10.1080/14740338.2021.1951219. Online ahead of print.ABSTRACTBACKGROUND: Hypernatremia and liver injury are typical adverse effects of tolvaptan. Therefore, hospitalization and frequent monitoring of serum sodium concentration and liver function are necessary for tolvaptan initiation. We performed a cross-sectional survey to evaluate these situations.RESEARCH DESIGN AND METHODS: We employed the Japanese claims database, which contains data of patients aged
Source: Expert Opinion on Drug Safety - July 6, 2021 Category: Drugs & Pharmacology Authors: Shungo Imai Kenji Momo Hitoshi Kashiwagi Yuki Sato Takayuki Miyai Mitsuru Sugawara Yoh Takekuma Source Type: research

Safety review of anti-VEGF therapy in patients with myopic choroidal neovascularization
Expert Opin Drug Saf. 2021 Jul 6. doi: 10.1080/14740338.2021.1952979. Online ahead of print.ABSTRACTINTRODUCTION: Anti-angiogenesis therapy with intravitreal anti-VEGF agents is now the standard-of-care treatment for myopic choroidal neovascularization (CNV).AREAS COVERED: We provide a critical review of the safety of all the anti-VEGF agents currently used for treating myopic CNV including ranibizumab, aflibercept, conbercept, bevacizumab and ziv-aflibercept.EXPERT OPINION: Anti-VEGF therapy for myopic CNV with the currently available anti-VEGF drugs generally have favorable safety outcomes in the short-term. Nonetheless,...
Source: Expert Opinion on Drug Safety - July 6, 2021 Category: Drugs & Pharmacology Authors: Danny S C Ng Mary Ho Lawrence P L Iu Timothy Y Y Lai Source Type: research

Effect of levosimendan on renal function in background of left ventricular dysfunction: a meta-analysis of randomized trials
CONCLUSIONS: Levosimendan might improve renal function of patients with LVD.PMID:34214005 | DOI:10.1080/14740338.2021.1951700 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 2, 2021 Category: Drugs & Pharmacology Authors: Yu-Xiang Long Di-Yu Cui Xue Kuang Yue Hu Shuang Hu Chun-Ping Wang Zeng-Zhang Liu Source Type: research