FDA: Safety Warning Issued for Influenza Drug Relenza
The maker of the antiviral drug Relenza (zanamivir) informed health care professionals this week of a potential risk of behavioral changes and delirium associated with the drug's use. Relenza is approved for the treatment of influenza A and B.
THURSDAY, April 3 (HealthDay News) -- The maker of the antiviral drug Relenza (zanamivir) informed health care professionals this week of a potential risk of behavioral changes and delirium associated with the drug's use. Relenza is approved for the treatment of influenza A and B.
GlaxoSmithKline, the manufacturer of Relenza, shared information from postmarketing reports of delirium and abnormal behavior leading to injury in patients with influenza taking neuraminidase inhibitors, including Relenza. These events occurred primarily in children, and were often associated with abrupt onset and rapid resolution. Based on usage data for Relenza, it appears that such neuropsychiatric events are uncommon. In addition, causation of these events by Relenza has not been definitively established.
Health care professionals are urged to monitor their patients taking Relenza for any signs of abnormal behavior, and consider discontinuing the drug should neuropsychiatric symptoms occur. In addition, any adverse events suspected to be related to Relenza use should be reported to the U.S. Food and Drug Administration.
The labeling of Relenza has been updated to reflect these new safety warnings. "GlaxoSmithKline will continue to monitor the safety of Relenza through established reporting mechanisms and notify regulatory authorities of any serious adverse events for evaluation," said Dr. Judith Ng-Cashin, M.D., GlaxoSmithKline's director, in a letter to health care professionals.
More InformationMore Information
Copyright © 2008 ScoutNews, LLC. All rights reserved.
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.
