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The authors of the paper “Long term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail elderly population”, published in the Journal of the American Geriatrics Society in 2001, were recently made aware of a difference in the number of psychiatric events between the oseltamivir and placebo treatment arms from that used to write the original manuscript. The corrected information, to replace the original Table 4 of the publication, now includes psychiatric events (below). The error occurred in the misclassification of confusion, a neuropsychiatric event, reducing the count in the placebo treatment group by one, and increasing the count in the oseltamivir treatment group by one. The newly reported event was seen in an 82-year old man with a history of coronary artery and Parkinson's disease who became severely confused and was hospitalized on study day 27, at which time his anticoagulants and aspirin were stopped. Study medication was withdrawn on day 28. On study day 29 he was discharged and study medication was restarted. Mild confusion was reported from day 32 to day 34, but this resolved while the patient remained on oseltamivir. Both events were considered unrelated to study medication by the investigator. Although the reclassification results in a statistically significant difference between the two treatment groups on neuropsychiatric events (P = 0.046, Chi square), the frequency is sufficiently low that it does not impact or change the overall results or outcomes of the study or the clinical implications for this population.

Corrected version of Table 4.1 Summary of Most Common Adverse Events During Treatment With Oseltamivir 75 mg or Placebo Once Daily for 6 weeks

 Placebo (n = 272) (%)Oseltamivir 75 mg (n = 276) (%)
Fatigue20 (7.4)24 (8.7)
Nasal congestion20 (7.4)20 (7.2)
Cough22 (8.1)13 (4.7)
Sore throat18 (6.6)7 (2.5)
Headache15 (5.5)23 (8.3)
Influenza-like illness15 (5.5)13 (4.7)
Pyrexia15 (5.5)7 (2.5)
Nausea11 (4.0)12 (4.3)
Diarrhea11 (4.0)9 (3.3)
Neuropsychiatric Events4 (1.5)12 (4.3)
Vomiting4 (1.5)5 (1.8)
Urinary tract infection11 (4.0)10 (3.6)

Yours sincerely,

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Stefan Gravenstein, MD, MPH, CMD

Professor of Medicine and Health Services, Policy and Practice

The Warren Alpert Medical School of Brown University

Providence, RI

Patrick H. Peters, Jr., MD, PA

Texas Medical Research Associates

San Antonio, Texas

Reference

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  • 1
    Peters P, Gravenstein S, De Bock VNorwood P, De Bock V, et al. Long term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail elderly population. J Am Geriatr Soc 2004;49(8):202531.