FDA allows uncleared uses of flu drugs, tests

The U.S. Food and Drug Administration authorized emergency uses of the flu drugs Tamiflu and Relenza on Monday and a diagnostic test to help get a grip on a new strain of swine flu, the agency said on Monday.

The U.S. government's declaration on Sunday that the swine flu is a public health emergency freed the FDA to take such action, the agency said in a statement.

The FDA will now have the authority to allow public health and medical personnel to prescribe Relenza, GlaxoSmithKline's inhaled flu drug also known as zanamivir, and Roche AG's Tamiflu, a pill also known as oseltamivir, for unapproved uses.

Tamiflu, approved for treating and preventing the flu in people over a year old, can now be used in children under 1 year. Doctors can also change the recommended dosage for children older than 1 year under the emergency use authorization.

The FDA also gave more healthcare workers authority to distribute Tamiflu and Relenza, including some public health officials and volunteers.

More than 40 people have been sickened by the new flu strain in the United States.

The rRT-PCR Swine Flu Panel diagnostic test was authorized for testing samples from flu patients to determine if they have the new strain.

A positive finding will presumptively conclude that the patient has the new, previously unseen strain of H1N1 swine flu. But a negative result will not be considered conclusive that a patient does not have the virus, the agency said.

Source : www.reuters.com