Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000 –2020
ConclusionAlthough most patients who initiated lenalidomide, pomalidomide, and thalidomide were not of child-bearing potential, further investigation into actual non-adherence to pregnancy testing is needed. (Source: Drug Safety)
Source: Drug Safety - May 16, 2024 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
ConclusionsThe patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs. Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immune-mediated phenomena post-COVID-19 vaccination. The relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19, and non-COVID illnesses sho...
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
ConclusionsPost-conceptional exposure to clomiphene citrate was not associated with an increased risk of major congenital malformations. Given potential confounding and information biases, the results about minor malformations should be interpreted with caution as no specific clinical pattern was identified. (Source: Drug Safety)
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
ConclusionsThese predictors could help identify the individuals at the highest risk and enable targeted interventions to be designed. (Source: Drug Safety)
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
ConclusionsThe patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs. Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immune-mediated phenomena post-COVID-19 vaccination. The relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19, and non-COVID illnesses sho...
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
ConclusionsPost-conceptional exposure to clomiphene citrate was not associated with an increased risk of major congenital malformations. Given potential confounding and information biases, the results about minor malformations should be interpreted with caution as no specific clinical pattern was identified. (Source: Drug Safety)
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
ConclusionsThese predictors could help identify the individuals at the highest risk and enable targeted interventions to be designed. (Source: Drug Safety)
Source: Drug Safety - May 13, 2024 Category: Drugs & Pharmacology Source Type: research

Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
ConclusionA sizable proportion of sotrovimab-treated participants in the COVID-PR had underlying medical conditions associated with an increased risk of severe COVID-19. None of the assessable SAEs were considered to be related to sotrovimab treatment. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
ConclusionsApart from the expected association with clozapine, chlorpromazine and cyamemazine (sharing an aromatic heteropolycyclic molecular structure) emerged with a higher-than-expected reporting of DRESS. Better knowledge of the antipsychotic-related DRESS syndrome should increase clinicians ’ awareness leading to safer prescribing of antipsychotics. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
ConclusionsExposure to inappropriate medication use involving opioids in the 90 days before death is associated with an increased risk of mortality in older adults. These findings can be used to encourage safer pain management strategies in older adults. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
ConclusionA sizable proportion of sotrovimab-treated participants in the COVID-PR had underlying medical conditions associated with an increased risk of severe COVID-19. None of the assessable SAEs were considered to be related to sotrovimab treatment. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
ConclusionsExposure to inappropriate medication use involving opioids in the 90 days before death is associated with an increased risk of mortality in older adults. These findings can be used to encourage safer pain management strategies in older adults. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
ConclusionsApart from the expected association with clozapine, chlorpromazine and cyamemazine (sharing an aromatic heteropolycyclic molecular structure) emerged with a higher-than-expected reporting of DRESS. Better knowledge of the antipsychotic-related DRESS syndrome should increase clinicians ’ awareness leading to safer prescribing of antipsychotics. (Source: Drug Safety)
Source: Drug Safety - May 9, 2024 Category: Drugs & Pharmacology Source Type: research

Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
ConclusionsIn this population-based cohort study, the use of DPP-4 inhibitors, when compared with SGLT-2 inhibitors, was associated with a moderately increased risk of gallbladder and bile duct disease among patients with type 2 diabetes. This outcome was still quite rare with a high number needed to harm at 6 months and 1 year. (Source: Drug Safety)
Source: Drug Safety - May 8, 2024 Category: Drugs & Pharmacology Source Type: research

A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines
(Source: Drug Safety)
Source: Drug Safety - May 8, 2024 Category: Drugs & Pharmacology Source Type: research