FDAnews Drug Daily Bulletin


March 29, 2006

The FDA has released a proposed final rule prohibiting the used of two classes of approved human influenza drugs in poultry.

The action aims to help preserve the effectiveness of these drugs for treating or preventing influenza infections in humans, according to the FDA's recent notice.

Specifically, the order prohibits veterinarians from using Roche's Tamiflu (oseltamivir phosphate) and GlaxoSmithKline's Relenza (zanamivir) in chickens, turkeys and ducks. The FDA also is prohibiting the use of two older anti-influenza drugs -- amantadine and rimantadine -- in these birds.

"Today's action is a preventive measure designed to protect the public health and illustrates FDA's high level of commitment and key role in preparing for a possible influenza pandemic, which is a top priority for our nation" said acting FDA Commissioner Andrew von Eschenbach.

The FDA said it is unaware of any ongoing extralabel use of these antiviral drugs by U.S. poultry producers. Extralabel use refers to using the drug in animals in a manner that is not in accordance with its approved labeling. The agency also noted there have been no reported U.S. cases of avian influenza H5N1, a deadly strain of the flu found in birds and shown to be spreading around the globe.

For more information, access http://www.fda.gov/bbs/topics/NEWS/2006/NEW01339.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01339.html).