Articles related to PATIENT SAFETY

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.

Two large scale studies featured in The British Medical Journal concluded that mRNA-based vaccines do not appear to be associated with an increased risk of neurological adverse events; and secondly, that risks of Guillain-Barré syndrome and Bell’s palsy are slightly increased after immunization. Overall, the findings of both studies are reassuring about the safety of the vaccines, particularly compared with the observed risks associated with SARS-CoV-2 infection.

The U.S. Food and Drug Administration (FDA) held a two-day public meeting to discuss managing the potential side effects of gene therapies following the death of a boy with a rare neuromuscular disease. High doses of gene therapies are known to cause liver damage, and recent studies have also found a potential long-term cancer risk in mice and dogs treated with gene therapies.