Safety profile of oseltamivir during the 2009 influenza pandemic
Identifieur interne : 000983 ( Istex/Curation ); précédent : 000982; suivant : 000984Safety profile of oseltamivir during the 2009 influenza pandemic
Auteurs : Barbara Donner [Suisse] ; Silvia Bader-Weder [Suisse] ; Roman Schwarz [Suisse] ; Michael M. Peng [États-Unis] ; James Robert Smith [Suisse] ; Viswanathan Niranjan [Inde]Source :
- Pharmacoepidemiology and Drug Safety [ 1053-8569 ] ; 2011-05.
English descriptors
- Teeft :
- Abnormal behavior, Adverse events, Antiviral medications, Birth defects, Causal link, Causal relationship, Clin drug investig, Clinical aspects, Clinical features, Clinical trials, Concomitant medications, Confidence interval, Consumer reports, Copyright, Countries exposure cases, Crude incidence rates, Crude rate ratio, Database, Disease control, Disease progression, Distress syndrome, Donner, Drug safety, Elderly subpopulation, Elsevier saunders, Engl, Esophageal carcinoma, Euro surveill, Events hepatic failure, Events rate, Fatal cases, Fatal outcome, Fatal outcomes, Febrile seizures, Fourth case, Gastrointestinal hemorrhage, General signs, Health care, Health care professionals, Healthcare products, Higher level terms, Hlts, Immunocompromised, Immunocompromised patients, Immunocompromised status, Infection, International conference, Japan exposure cases, John wiley sons, Large increase, Lower level terms, Mcgraw hill, Medical history, Medical information, Medical review, Medication, Medication errors, Myocarditis, Neuraminidase, Oseltamivir, Oseltamivir phosphate, Oseltamivir treatment, Other countries, Pandemic, Pandemic period, Patient exposure, Patient subpopulations, Pharmacoepidemiology, Preferred terms, Pregnancy exposure, Pregnant women, Prepandemic, Prepandemic period, Prepandemic periods, Prophylaxis, Pulmonary disease, Respiratory complications, Respiratory failure, Risk factor, Risk factors, Roche, Roche safety database, Saes, Safety database, Serious events, Spontaneous abortion, Spontaneous reports, Subpopulation, Supplementary data, Supplementary table, Supplementary tables, Technical requirements, Therapeutic abortion, Ventricular arrhythmia, Virus infection, World health organization.
Abstract
Purpose: This study evaluated the safety of oseltamivir during the 2009 influenza pandemic. Methods: Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) for USA and Japan only, as exposure data in other countries were collected inconsistently. Events with significantly higher reporting during the pandemic (lower bound of 95%CI for crude rate ratio >1) were analyzed further. Results: Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 events) and 62.0 million (8387 cases, 12 749 events), respectively. AEs with significantly higher reporting during the pandemic were generally consistent with influenza and its complications and/or with the circulation of a novel virus strain. As might be expected in a pandemic, mortality increased (crude rate ratio, 2.83; 95%CI, 2.23–3.59) versus the prepandemic period. Medical review of serious AEs (fatal or non‐fatal outcome) found that most were consistent with pre‐existing risk factors, underlying disease, and/or progression of influenza or its complications. Analysis of the remainder did not suggest a causal link with oseltamivir. A review of AEs in previously underexposed subpopulations did not support an association with oseltamivir. Conclusions: During the first 8 months of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir were consistent with the drug's labeled safety profile, underlying medical conditions, or infection with the pandemic virus. Copyright © 2011 John Wiley & Sons, Ltd.
Url:
DOI: 10.1002/pds.2136
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Methods: Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) for USA and Japan only, as exposure data in other countries were collected inconsistently. Events with significantly higher reporting during the pandemic (lower bound of 95%CI for crude rate ratio >1) were analyzed further. Results: Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 events) and 62.0 million (8387 cases, 12 749 events), respectively. AEs with significantly higher reporting during the pandemic were generally consistent with influenza and its complications and/or with the circulation of a novel virus strain. As might be expected in a pandemic, mortality increased (crude rate ratio, 2.83; 95%CI, 2.23–3.59) versus the prepandemic period. Medical review of serious AEs (fatal or non‐fatal outcome) found that most were consistent with pre‐existing risk factors, underlying disease, and/or progression of influenza or its complications. Analysis of the remainder did not suggest a causal link with oseltamivir. A review of AEs in previously underexposed subpopulations did not support an association with oseltamivir. Conclusions: During the first 8 months of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir were consistent with the drug's labeled safety profile, underlying medical conditions, or infection with the pandemic virus. Copyright © 2011 John Wiley & Sons, Ltd.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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