NEW YORK — The Food and Drug Administration says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.

There have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML, since mid-2006. The reports are the first confirmed new cases since June. While the disease is rare, the FDA says the risk appears to increase as patients remain on Tysabri.

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The Center for Disease Control and Prevention (CDC) has officially stated that there will be as many as 30,000 serious, potentially lethal adverse reactions to the novel H1N1 vaccine, while the FDA guidelines for the novel H1N1 vaccine only require that it work in 3 out of every 10 recipients.

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The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.

The EUA allows the U.S. Department of Defense to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results. An EUA authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency.

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