FDA Has Issued Emergency Use Authorizations for Two Antiviral Treatments — Tamiflu (oseltamavir) and Relenza (zanamivir)

Stockpiled Antivirals at or Nearing Expiration

During
this public health emergency, the FDA has issued Emergency Use
Authorizations that expand access to medical products that may become
necessary.

Two antiviral treatments covered by Emergency Use Authorizations,
Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included
in many emergency stockpiles.

All companies, U.S. states and localities, and other organizations
with Tamiflu and Relenza that are approaching, or past, the labeled
expiration date, are urged to consider keeping it while the U.S.
Department of Health and Human Services evaluates options, including
those that may allow for their use if needed during this 2009 H1N1 flu
virus outbreak.

If the stockpiling entity decides to retain expired or
soon-to-expire Tamiflu and Relenza, it should be maintained and
monitored under the product’s labeled storage conditions.

These organizations are also urged to contact the FDA’s Emergency
Operations Center with information on how much Tamiflu and Relenza in
their stockpiles is at or approaching expiration.

This information should be reported to:

FDA’s Emergency Operations Center
301-443-1240.

This statement is not directed to individual patients who already
have these two products in their homes. Individuals with these products
should continue to follow the directions from their doctor, pharmacist
or other health care professional.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.