tetano
Editor, Senior Moderator
Clin Infect Dis. 2012 Apr 5. [Epub ahead of print]
Emergency Use Authorization for Intravenous Peramivir: Evaluation of Safety in the Treatment of Hospitalized Patients Infected with 2009 H1N1 Influenza A Virus.
Sorbello A, Jones SC, Carter W, Struble K, Boucher R, Truffa M, Birnkrant D, Gada N, Camilli S, Chan I, Dallas S, Scales T, Kosko R, Thompson E, Goodman J, Francis H, Dal Pan G.
Source
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Silver Spring, MD.
Abstract
BackgroundOn October 23, 2009, FDA issued an emergency use authorization (EUA) for intravenous peramivir, an unapproved antiviral, to treat suspected or confirmed 2009 H1N1 influenza A virus infection. Eligible hospitalized patients were unable to tolerate or unresponsive to available antivirals or lacked dependable oral or inhaled drug delivery routes. The EUA required healthcare providers to report medication errors, selected adverse events, serious adverse events (SAE), and deaths to FDA.MethodsAn FDA safety team analyzed reports submitted to the Adverse Event Reporting System (AERS) and sought follow-up in selected cases.ResultsFDA received AERS reports for 344 patients (including 28 children and 3 pregnant women). Many patients were critically ill on mechanical ventilation (41%) and renal replacement therapies (19%); 38% had received oseltamivir. The most frequently reported SAEs by MedDRA preferred term were death (15%), H1N1 influenza (8%), respiratory failure (8%), acute renal failure (7%), and acute respiratory distress syndrome (7%). Six medication errors were reported. Most deaths occurred among patients who were obese, immunosuppressed, >65 years old, or received oseltamivir. Rash was the only treatment-emergent AE attributable to peramivir. Influenza severity, co-morbidities, and concomitant medications confounded additional peramivir-AE assessments. Missing clinical and laboratory data precluded evaluation of some reports.ConclusionsMany peramivir recipients under the EUA were critically ill and at risk for influenza-related complications. The safety data were insufficient to assess whether peramivir affected outcome or caused adverse reactions other than rash. Clinical trials in hospitalized patients with serious influenza infections should provide additional information.
PMID:
22491501
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22491501
Emergency Use Authorization for Intravenous Peramivir: Evaluation of Safety in the Treatment of Hospitalized Patients Infected with 2009 H1N1 Influenza A Virus.
Sorbello A, Jones SC, Carter W, Struble K, Boucher R, Truffa M, Birnkrant D, Gada N, Camilli S, Chan I, Dallas S, Scales T, Kosko R, Thompson E, Goodman J, Francis H, Dal Pan G.
Source
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Silver Spring, MD.
Abstract
BackgroundOn October 23, 2009, FDA issued an emergency use authorization (EUA) for intravenous peramivir, an unapproved antiviral, to treat suspected or confirmed 2009 H1N1 influenza A virus infection. Eligible hospitalized patients were unable to tolerate or unresponsive to available antivirals or lacked dependable oral or inhaled drug delivery routes. The EUA required healthcare providers to report medication errors, selected adverse events, serious adverse events (SAE), and deaths to FDA.MethodsAn FDA safety team analyzed reports submitted to the Adverse Event Reporting System (AERS) and sought follow-up in selected cases.ResultsFDA received AERS reports for 344 patients (including 28 children and 3 pregnant women). Many patients were critically ill on mechanical ventilation (41%) and renal replacement therapies (19%); 38% had received oseltamivir. The most frequently reported SAEs by MedDRA preferred term were death (15%), H1N1 influenza (8%), respiratory failure (8%), acute renal failure (7%), and acute respiratory distress syndrome (7%). Six medication errors were reported. Most deaths occurred among patients who were obese, immunosuppressed, >65 years old, or received oseltamivir. Rash was the only treatment-emergent AE attributable to peramivir. Influenza severity, co-morbidities, and concomitant medications confounded additional peramivir-AE assessments. Missing clinical and laboratory data precluded evaluation of some reports.ConclusionsMany peramivir recipients under the EUA were critically ill and at risk for influenza-related complications. The safety data were insufficient to assess whether peramivir affected outcome or caused adverse reactions other than rash. Clinical trials in hospitalized patients with serious influenza infections should provide additional information.
PMID:
22491501
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22491501