Re: Tamiflu: 14 flu seasons and still questions
27 January 2013
To the Editor:
Two of the 14-year-old Tamiflu questions, efficacy and reduction of influenza complications, raised by Krumholz and colleges in their January 25, 2013 editorial appear to have been substantially addressed 13 years ago in the professional product label or package insert for the drug.
Regarding efficacy, this is the statement that appeared in the Clinical Studies section of Tamiflu’s November 2000 professional labeling: “…there was a 1.3 day reduction in the median time to improvement in influenza-infected subjects receiving TAMIFLU compared to subjects receiving placebo.” This same label goes on to say that: “Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. TAMIFLU has not been shown to prevent such complications.”
The Food and Drug Administration (FDA) Division Director’s Memo dated October 1999 noted that “… oseltamivir confers a modest clinical benefit …” and that the Tamiflu application does not contain information on the “… effectiveness in preventing complications due to influenza….”
Tamiflu’s professional product label has been amended to say that in a pooled analysis of 3 clinical trials of subjects’ age 65 and older “… there was a 1-day reduction in the median time to improvement in influenza-infected subjects receiving TAMIFLU compared to those receiving placebo.”
The references cited are free and publically available on FDA and US National Library of Medicine Web sites.
Tamiflu’s “modest” efficacy and that the drug has not been shown to prevent bacterial complications of influenza have been known for over a decade. A quick reading of the drug’s professional labeling should have raised questions about the enthusiasm for Tamiflu. Accessing FDA approval documents that can contain unpublished analyses and analyses of unpublished clinical trials provide additional documentation for the information provided in professional product labels.
 Krumholz HM, Jackevicius CA, Ross JS. Tamiflu: 14 flu seasons and still questions. BMJ. 2013-01-25 14:20:28 2013;346.
 Roche Laboratories, Inc. Oseltamivir (Tamiflu) Professional Product Label revised November 2000. At
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf. Accessed January 27, 2013.
 Jolson HM, Director, Division of Antiviral Drug Products. Division Director Memorandum: Oseltamivir (Tamiflu), October 25, 1999. At http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu_medr_.... Accessed January 27, 2013.
 Genentech Inc. Oseltamivir (Tamiflu) Professional Product Label revised December 2012. At http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee3c9555-60f2-4f82.... Accessed January 27, 2013.
Competing interests: None declared
Saudi Arabian Food and Drug Authority, Riyadh, Saudi Arabia
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