Tamiflu and Relenza may be used for the Swine Flu outbreak

Health officials have been given permission by federal agencies to use Tamiflu and Relenza to try to help people who may - or may not have been - exposed to the new strain of Swine Flu recover more quickly.

The government also has approved the use of a testing tool that could help diagnose flu cases locally, which could speed up the process of confirming cases of human-Swine Flu.

Currently, suspected cases of Swine Flu are sent to the U.S. Centers for Disease Control and Prevention for confirmation. The CDC is the only agency that has samples of the genetic material from this new flu strain - which is actually a combination of four influenza “pieces” - including the avian flu, according to information previously released by the CDC.

The U.S. Food and Drug Administration, in response to requests from the CDC, has now issued Emergency Use Authorizations (EUAs) for the use of Relenza and Tamiflu antiviral products, and for a rRT-PCR Swine Flu Panel diagnostic test.

The Emergency Use Authorizations also allows the FDA to OK the use of unapproved or “uncleared” medical products - or uses of medical products - following a declaration of emergency.

The EUA authority is part of Project BioShield, which became law in July 2004.

Tamiflu for children under age 1

Tamiflu is currently approved for treatment and prevention of influenza in patients ages 1 year and older.

Relenza is currently approved to treat acute, “uncomplicated” influenza - meaning no other illnesses are involved - for children ages 7 years and older and for adults who have been symptomatic for less than two days, and for the prevention of influenza for children 5 years and older and adults.

The EUA now allows Tamiflu to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year.

Also, both Tamiflu and Relenza may be distributed to large segments of the population without complying with the label requirements, accompanied by written information pertaining to the emergency use.

They may also be distributed by a broader range of health care workers, including volunteers, in accordance with state and local laws and/or public health emergency responses.

Faster test results

The FDA also may now issue a EUA for the rRT-PCR Swine Flu Panel diagnostic test, which may be effective for follow-up testing of samples from individuals diagnosed with influenza A infections, if analysis of a sample from that individual doesn’t come up as a known flu virus.

The CDC now can distribute the swine flu test to public health and other qualified laboratories that have the right equipment and where the personnel are trained to perform and interpret the results.

This test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumed infected with swine flu virus but it does not indicate the stage of the infection.

The CDC notes, however, that a negative test result does not exclude the possibility of swine flu virus infection. This would be determined at the CDC labs.

0 comments:

Post a Comment