The FDA approves 2008-09 flu vaccine – UPI.com

The FDA approves 2008-09 flu vaccine – UPI.com
WASHINGTON, Aug. 5 (UPI) — The U.S. Food and Drug Administration has approved the 2008-09 seasonal influenza vaccine that includes strains likely to cause flu in the United States.

The FDA changed all three strains for this year’s influenza vaccine — an unusual occurrence, as usually only one or two strains are updated from year to year.

They truly have a tough job: predict the future.  Get it right and nobody notices, get it wrong and there’s plent of fingers pointing at you.

Here’s hoping for an uneventful flu season.

Epilepsy Drugs May Avoid Black Box – WSJ.com

There may be hope for the FDA on black boxes just yet…

Epilepsy Drugs May Avoid Black Box – WSJ.com
Epilepsy Drugs May Avoid Black Box
By JARED A. FAVOLE
July 11, 2008; Page B6

BELTSVILLE, Md. — A Food and Drug Administration panel has recommended against adding the agency’s toughest warnings to labels of epilepsy drugs, saying studies didn’t show a high-enough risk for suicidal behavior to warrant such warnings.

So, the full FDA panel realizes hitting medications with a Black Box makes doctors not want to prescribe them, and said the very small increase in suicides among people taking epilepsy drugs didn’t warrant the warning.

So, if an increase in suicidality isn’t boxable, what about tendons and tendon ruptures?