Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics
AbstractFor any therapeutic intervention in an individual, there is a balance between the potential benefits and the possible harms. The extent to which the benefits are desirable in a given condition depends on the efficacy of the intervention, the chance of obtaining it and the seriousness and intensity of the condition. The extent to which the harms are undesirable depends on the nature of the hazard that can lead to harm, the chance that the harm will occur and its seriousness and intensity. Rational therapeutic decisions require clinicians to consider competing courses of action, with potential benefits of different d...
Source: Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Source Type: research
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study
ConclusionsIn this real-world study, ixekizumab was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis, with no difference in safety across most patient subgroups. (Source: Drug Safety)
Source: Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Source Type: research
Timing Matters: A Machine Learning Method for the Prioritization of Drug –Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure
ConclusionsOur method was able to prioritize disproportionality signals with temporal plausibility. This finding suggests a potential for our method in pinpointing signals that are more likely to be furtherly validated. (Source: Drug Safety)
Source: Drug Safety - April 30, 2024 Category: Drugs & Pharmacology Source Type: research
Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values
ConclusionFor studies in subjects with abnormal baseline values, the composite plot has potential application in the assessment of beneficial and concerning on-treatment modifications in liver test values in reference to the individual subject ’s baseline and population threshold values. (Source: Drug Safety)
Source: Drug Safety - April 20, 2024 Category: Drugs & Pharmacology Source Type: research
Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
(Source: Drug Safety)
Source: Drug Safety - April 18, 2024 Category: Drugs & Pharmacology Source Type: research
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
AbstractEnzalutamide is an oral androgen receptor signaling inhibitor utilized in the treatment of men with prostate cancer. It is a moderate inducer of the cytochrome P450 (CYP) enzymes CYP2C9 and CYP2C19, and a strong inducer of CYP3A4. It was also shown to be a mild inhibitor of the efflux transporter P-glycoprotein in patients with prostate cancer. Enzalutamide is primarily metabolized by CYP3A4 and CYP2C8. The risk of enzalutamide drug interactions arises primarily when it is coadministered with other drugs that interact with these CYPs, including CYP3A4. In this review, we begin by providing an overview of enzalutami...
Source: Drug Safety - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance
ConclusionsConsumer reporting to the European Union spontaneous data collection system, EudraVigilance, was of high value for regulatory safety reviews, albeit the reporting behaviours were not free of the influence of the media. These sources of information can be investigated to understand the context of safety concerns of public health interest. (Source: Drug Safety)
Source: Drug Safety - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
AbstractEnzalutamide is an oral androgen receptor signaling inhibitor utilized in the treatment of men with prostate cancer. It is a moderate inducer of the cytochrome P450 (CYP) enzymes CYP2C9 and CYP2C19, and a strong inducer of CYP3A4. It was also shown to be a mild inhibitor of the efflux transporter P-glycoprotein in patients with prostate cancer. Enzalutamide is primarily metabolized by CYP3A4 and CYP2C8. The risk of enzalutamide drug interactions arises primarily when it is coadministered with other drugs that interact with these CYPs, including CYP3A4. In this review, we begin by providing an overview of enzalutami...
Source: Drug Safety - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
AbstractAdditional risk minimization strategies may be required to assure a positive benefit –risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (H CPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnan...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
AbstractDuring the COVID-19 vaccination campaign, observed-to-expected analysis was used by the European Medicines Agency to contextualise data from spontaneous reports to generate real-time evidence on emerging safety concerns that may impact the benefit-risk profile of COVID-19 vaccines. Observed-to-expected analysis compares the number of cases spontaneously reported for an event of interest after vaccination ( ‘observed’) to the ‘expected’ number of cases anticipated to occur in the same number of individuals had they not been vaccinated. Observed-to-expected analysis is a robust methodology that relies on seve...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
AbstractAdditional risk minimization strategies may be required to assure a positive benefit –risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (H CPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnan...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
AbstractDuring the COVID-19 vaccination campaign, observed-to-expected analysis was used by the European Medicines Agency to contextualise data from spontaneous reports to generate real-time evidence on emerging safety concerns that may impact the benefit-risk profile of COVID-19 vaccines. Observed-to-expected analysis compares the number of cases spontaneously reported for an event of interest after vaccination ( ‘observed’) to the ‘expected’ number of cases anticipated to occur in the same number of individuals had they not been vaccinated. Observed-to-expected analysis is a robust methodology that relies on seve...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Fatal Intoxications with Zopiclone —A Cause for Concern?
ConclusionThis study demonstrates that the toxicity of zopiclone can be lethal both in combination with other substances and on its own. Most individuals dying in fatal zopiclone intoxications were prescribed zopiclone, which potentially indicates that a more restrictive prescribing rate could prevent future intoxication deaths, especially when caring for patients with an increased suicide risk. (Source: Drug Safety)
Source: Drug Safety - March 27, 2024 Category: Drugs & Pharmacology Source Type: research
