FDA Issues Emergency OK for Broad Use of Antiviral Drugs

Action gives health authorities leeway to distribute Relenza and Tamiflu in response to threat
By Jeff Muise
HealthDay Reporter

TUESDAY, April 28 (HealthDay News) -- In response to the threat of a swine flu epidemic, the U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) to permit broader use of the antiviral medications zanamivir (Relenza) and oseltamivir (Tamiflu), and the use of the rRT-PCR Swine Flu Panel diagnostic test.

The EUA will enable medical authorities to distribute the medications to large segments of the population without complying with the label requirements. They also may be distributed by a broader range of health care workers, including some public health officials and volunteers, as part of the emergency response. The EUA also permits the use of Tamiflu in children under 1 year old, contrary to the current FDA-approved dosing, and provides alternate dosing recommendations for children older than 1 year.

The FDA said the EUA for the rRT-PCR Swine Flu Panel diagnostic test was based on the determination that it may be effective in testing samples from individuals with influenza A, whose virus cannot be identified by current tests. The EUA allows the specialized swine flu test to be distributed to public health and qualified laboratories that have the appropriate equipment and personnel.

The emergency authorization came at the request of the U.S. Centers for Disease Control and Prevention to make the diagnostic and therapeutic tools available to public health and medical personnel should circumstances warrant in the fast-moving outbreak. Health care professionals and consumers can report serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program by regular mail (MedWatch, 5600 Fishers Lane, Rockville, Md. 20852-9787), fax (800-FDA-0178), phone (800-FDA-1088), or online.

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