FDA Authorizes Emergency Use of Drugs and Diagnostic Test to Combat Swine Flu

In response to the fast-growing global outbreak of swine flu, the Food and Drug Administration has just approved the emergency use of two influenza drugs — Tamiflu and Relenza — as well as a diagnostic test that can more accurately detect the new strain of the deadly flu.

The FDA announcement comes just days after the U.S. government issued a public health emergency about swine flu, an infectious disease that has killed more than 100 people in Mexico and sickened more than 1,000 people around the world.

So far, at least 40 people have been sickened by the new flu strain in the United States. None of those cases was fatal, but officials are concerned that more cases may be diagnosed.

Broader Use of Drugs Approved

Tamiflu, a Roche AG drug also called oseltamivir, is an antiviral medication approved for use in the treatment and prevention of influenza in children under age 1. Relenza, a GlaxoSmithKline drug also known as zanamivir, is approved for use in treating flu in adults and children as young as five. The rRT-PCR Swine Flu Panel diagnostic test can better determine whether an infected person is carrying the new strain of the flu.

The FDA emergency announcement means more categories of public health and medical personnel will be authorized to distribute and prescribe the drugs to more people for currently unapproved uses. Under the new emergency rules, Tamiflu may now be used for children under 1 and physicians may also change the recommended dosage for children older than 1, the FDA said.

More Accurate Diagnostic Test Approved

Federal health officials also authorized the use of the rRT-PCR Swine Flu Panel diagnostic test to scan samples from flu patients to determine if they have the new strain. Current tests cannot detect all the virus subtypes that are suspected of creating the new strain of swine flu, officials said.

The diagnostic test uses a nasal or nasopharyngeal swap to amplify the genetic profile of the virus. A positive test result presumptively concludes that the patient is carrying the swine flu but cannot determine the stage of infection. However, a negative test result does not, on its own, conclude that a person does not carry the swine flu virus, officials cautioned.

The new FDA Emergency Use Authorization rules for the use of the drugs and the diagnostic test will remain in effect until the FDA takes action to terminate the changes.

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