Articles related to PATIENT SAFETY

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

Medical records of more than half a million individuals in the EU, UK, and US were evaluated. Apixaban was the most frequently prescribed direct oral anticoagulant (DOAC) for AFib. It was also associated with a lower incidence of GI bleed vs. the other DOACs.

The 100-μg dose of the ERBB2 ICD plasmid-based vaccine was associated with the generation of ERBB2-specific type 1 T cells in the majority of patients with ERBB2-expressing breast cancer in this phase 1 nonrandomized clinical trial, and it is currently being assessed in randomized phase 2 trials.

In this meta-analysis including 340 patients across six clinical trials, ECT was more effective than ketamine in treating depression. There were no identified differences between the groups in terms of cognition, memory, or serious adverse events.

In this study involving 452 patients with diagnoses of MDD, GAD, and PTSD, IM ketamine reduced depression by 38% and anxiety by 50%, with persistence over 7 months of maintenance therapy.

The US Food and Drug Administration (FDA) has said “no” to Akebia Therapeutics’ drug application for vadadustat, a therapy to treat anemia due to chronic kidney disease. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA cited safety concerns as the main reason for it rejecting the application.