We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu eye-related side effects, such as retinal … [Read more...]
Archives for February 2022
How People Can Report Adverse Drug Reactions to the FDA MedWatch Program
MedWatch is an FDA program for reporting “serious reactions” resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes: Patient's Death: an adverse reaction to a drug is the suspected cause of death Life-Threatening Condition: a serious … [Read more...]
An Overview of Benzene Exposure and its Adverse Health Effects
Benzene is a widely-used toxic chemical that is known to cause leukemia, according to the International Agency for Research on Cancer (IARC), the Environmental Protection Agency (EPA), and the Department of Health and Human Services (DHHS). Specifically, benzene exposure has been linked to acute myelogenous leukemia (AML). Besides the leukemia … [Read more...]
First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743
Background: In the phase 3 CheckMate 743 study (NCT02899299), first-line nivolumab plus ipilimumab significantly improved overall survival (OS) versus chemotherapy in patients with unresectable malignant pleural mesothelioma [(unresectable MPM)]. We report updated data with 3-year minimum follow-up. Patients and methods: Adults with previously … [Read more...]
Xeljanz, Rinvoq, and Olumiant Safety Review by European Drug Regulator EMA
The JAK inhibitors drug class safety issue has landed in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, “EMA starts safety review of Janus kinase inhibitors for inflammatory disorders”. This Xeljanz, Rinvoq, and Olumiant safety review by the EMA follows a December 2021 JAK inhibitors drug class safety FDA … [Read more...]
Incidence, treatment and survival of malignant pleural and peritoneal mesothelioma: a population-based study
Introduction: Malignant mesothelioma (MM) is an aggressive cancer that primarily arises from the pleura (MPM) or peritoneum (MPeM), mostly due to asbestos exposure. This study reviewed the Dutch population-based incidence, treatment and survival since the national ban on asbestos in 1993. Materials and methods: Patients with MPM or MPeM … [Read more...]
Possible Ukoniq Drug Recall Due to Increased Risk of Death
Ukoniq (umbralisib) was approved by the FDA in February 2021 to treat adults with two types of lymphoma cancer that have returned or it did not respond to prior treatment: Marginal Zone Lymphoma (MZL); and, Follicular Lymphoma (FL). Only a year later, however, there is a new FDA Ukoniq safety investigation after a so-called “safety signal” … [Read more...]
Malignant pleural mesothelioma patients’ experience by gender: findings from a cross-sectional UK-national questionnaire
OBJECTIVES: Malignant mesothelioma is an aggressive malignancy of mesothelial surfaces, most commonly those of the pleura. The aim of this study was to understand, using a national questionnaire, the gendered care experiences of patients with malignant pleural mesothelioma (MPM). Patients were asked about their experience of the diagnostic process, … [Read more...]
Xeljanz Safety Study Final Findings Presented in January 2022
The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA were examined in this January 26, 2022 article, “Trial Data Confirm Heightened Risks With JAK Inhibitor”, by medical news reporter John Gever for MedPage Today. That January 2022 MedPage Today news report provides a “snapshot” of the current … [Read more...]
Malignant pleural mesothelioma patients’ experience by gender: findings from a cross-sectional UK-national questionnaire
OBJECTIVES: Malignant mesothelioma is an aggressive malignancy of mesothelial surfaces, most commonly those of the pleura. The aim of this study was to understand, using a national questionnaire, the gendered care experiences of patients with malignant pleural mesothelioma (MPM). Patients were asked about their experience of the diagnostic process, … [Read more...]