Author ’s Reply to Kuss and Rathmann’s Comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data”
(Source: Drug Safety)
Source: Drug Safety - April 15, 2023 Category: Drugs & Pharmacology Source Type: research

Comment on & quot;Drug –Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data & quot;
(Source: Drug Safety)
Source: Drug Safety - April 15, 2023 Category: Drugs & Pharmacology Source Type: research

Author ’s Reply to Kuss and Rathmann’s Comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data”
(Source: Drug Safety)
Source: Drug Safety - April 15, 2023 Category: Drugs & Pharmacology Source Type: research

Comment on & quot;Drug –Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data & quot;
(Source: Drug Safety)
Source: Drug Safety - April 15, 2023 Category: Drugs & Pharmacology Source Type: research

Drug –Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study
ConclusionsWe evidenced an almost 2.5-fold increase in the risk of emergency hospitalizations during periods of exposure to contraindicated concomitant use of interacting drugs, with a potential public health impact exceeding 7000 preventable hospitalizations yearly in France. These results confirm the need to reinforce training in prescription practices and tools for prevention concerning contraindicated concomitant use of interacting drugs. These would especially concern drugs involved in an increase in long QT syndrome when associated such as citalopram, and highly prescribed drugs with a risk of overdose if co-prescrib...
Source: Drug Safety - April 12, 2023 Category: Drugs & Pharmacology Source Type: research

Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data
ConclusionsOur algorithm to identify stillbirths from administrative claims data had a moderately high PPV. Positive predictive value was substantially increased by restricting the setting to inpatient episodes and using only input diagnostic codes for singleton stillbirths. (Source: Drug Safety)
Source: Drug Safety - April 12, 2023 Category: Drugs & Pharmacology Source Type: research

Drug –Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study
ConclusionsWe evidenced an almost 2.5-fold increase in the risk of emergency hospitalizations during periods of exposure to contraindicated concomitant use of interacting drugs, with a potential public health impact exceeding 7000 preventable hospitalizations yearly in France. These results confirm the need to reinforce training in prescription practices and tools for prevention concerning contraindicated concomitant use of interacting drugs. These would especially concern drugs involved in an increase in long QT syndrome when associated such as citalopram, and highly prescribed drugs with a risk of overdose if co-prescrib...
Source: Drug Safety - April 12, 2023 Category: Drugs & Pharmacology Source Type: research

Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data
ConclusionsOur algorithm to identify stillbirths from administrative claims data had a moderately high PPV. Positive predictive value was substantially increased by restricting the setting to inpatient episodes and using only input diagnostic codes for singleton stillbirths. (Source: Drug Safety)
Source: Drug Safety - April 12, 2023 Category: Drugs & Pharmacology Source Type: research

Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities
AbstractPharmacovigilance leaders from major vaccine developers describe the learnings from the coronavirus disease 2019 (COVID-19) pandemic in the area of pharmacovigilance and pharmacoepidemiology. The authors aim to raise awareness of the co-operation among vaccine developers, highlight common challenges, advocate for solutions, and propose recommendations for the future in the areas of real-world safety and effectiveness, safety reporting and evaluation, and regulatory submissions. To enable timely evaluation of real-world safety and effectiveness, multi-sponsor study platforms were implemented, resulting in quicker re...
Source: Drug Safety - April 11, 2023 Category: Drugs & Pharmacology Source Type: research

Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
ConclusionThis large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials. (Source: Drug Safety)
Source: Drug Safety - April 7, 2023 Category: Drugs & Pharmacology Source Type: research

Erice Manifesto 2022: On the Surveillance of Potential Harms Caused by Food Supplements in Europe
(Source: Drug Safety)
Source: Drug Safety - April 6, 2023 Category: Drugs & Pharmacology Source Type: research

Conference on Advances in Pharmacovigilance for Herbal Medicines 12th –14th April 2023
(Source: Drug Safety)
Source: Drug Safety - March 30, 2023 Category: Drugs & Pharmacology Source Type: research