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Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project
The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studi...
Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends
Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends
Concerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, ...
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products
Funding No funding was received to write this book review. ...
Conference on Advances in Pharmacovigilance for Herbal Medicines 12th–14th April 2023
Conference on Advances in Pharmacovigilance for Herbal Medicines 12th–14th April 2023
Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a sh...
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data
Adverse drug reactions (ADRs) are a leading cause of mortality worldwide and should be detected promptly to reduce health ...
Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion
Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion
Detection of adverse reactions to drugs and biologic agents is an important component of regulatory approval and post-mark...
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study
Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries...
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22
Medicines cause over 1700 preventable deaths annually in England. Coroners’ Prevention of Future Death reports (PFDs...
Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System
Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System
Evidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immu...
Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency
Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency
Funding No funding was received for the preparation of this letter....
What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study
What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study
Previous studies have found differences in the communication of safety issues among medicines regulatory agencies. To expl...
The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations
The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations
The advent of the coronavirus disease 2019 (COVID-19) pandemic has led to the development of vaccines against severe acute...
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System
Deliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is ham...
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
Validation studies of algorithms for pregnancy outcomes based on International Classification of Diseases, 10th Revision, ...
Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study
Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study
Receipt of opioid agonist treatment during early and late pregnancy for opioid use disorder may relate to varying perinata...
Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
At the time of dapagliflozin’s approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns r...
Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration
Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration
Drug-induced liver injury is a significant health issue, yet the exposure-based incidence remains to be characterized. We ...
Effect of Previous Anticoagulant Treatment on Risk of COVID-19
Effect of Previous Anticoagulant Treatment on Risk of COVID-19
Little is known about the role played by anticoagulants in COVID-19. The aim of this study was to assess the impact of pre...
Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient...
Correction: Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
Correction: Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
Should Antidepressants be Avoided in Pregnancy?
Should Antidepressants be Avoided in Pregnancy?
Many (> 40%) women discontinue antidepressants during pregnancy because of concerns about effects on the foetus, ba...
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), am...
Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study
Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study
Pimavanserin is approved in the USA to treat hallucinations and delusions associated with Parkinson’s disease psycho...
Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management
Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management
Colchicine is useful for the prevention and treatment of gout and a variety of other disorders. It is a substrate for CYP3...
Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature
Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature
Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional ...
The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency relat...
Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®
Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®
While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in chil...
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