Label changes on the horizon for flu meds
The Pediatric Advisory Committee voted 9 to 5 to recommend a change in Tamiflu’s (oseltamivir) labeling.
The Pediatric Advisory Committee voted 9 to 5 to recommend a change in Tamiflu’s (oseltamivir) labeling to clarify the potential for neuropsychiatric adverse events, including self-injurious behavior, delirium, and hallucinations. However, the panel did not elaborate on what those changes should be.
A safety evaluator for the FDA said it is difficult to determine the link between oseltamivir and adverse neuropsychiatric events, but the drug’s contribution “cannot be completely excluded at this time.”The panel also voted to change the labeling of zanamivir (Relenza) to better reflect an increase in adverse events, but did not specify what the changes should be or if its label should be identical to the oseltamivir label.
According to the FDA, 25 patients under the age of 21 have died while using oseltamivir (21 of the deaths occurred in Japan, and three in the US). The Division of Drug Risk Evaluation noted that in Japan, some of the abnormal behaviors had a quick onset, and some occurred even while patients were being monitored.
CDC recommends nirsevimab be prioritized for highest-risk infants amid limited availability
October 26th 2023The Centers for Disease Control and Prevention is advising providers to prioritize 100 mg doses of nirsevimab, a monoclonal antibody FDA-approved to prevent respiratory syncytial virus (RSV), for infants at the highest risk of severe RSV disease.
Navigating a complex case of pediatric COVID-19 with immunomodulatory therapies
October 21st 2023Eculizumab and anakinra should be considered in critically ill patients with severe infections that require immunomodulating therapies for life-threatening dysregulation, according to a poster session at the 2023 American Academy of Pediatrics National Conference & Exhibition.
