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 B6BELTSVILLE, 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?
