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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: cliff who wrote (20691)4/16/1999 3:38:00 PM
From: RCMac  Read Replies (1) of 23519
 
>>just specifically what does it mean to be "black-boxed?"<<

Cliff,

The term "black -box" warning refers to a form of highlighting of warnings on FDA-approved labels (package inserts) for prescription drugs, commonly required for warnings of significant side effects or contraindications. Such warnings are set forth with a black border around them at the head of the label - literally with a black box around them.

The sense of many on this thread is that PFE's Viagra should have a black-box label to the effect that Viagra should not be taken by those with cardiac difficulties, especially those taking nitrate-based medications. VLAD would probably have the FDA require PFE to say, in that black box (or maybe a red one, with skull and crossbones), something like "Don't use this stuff, it could kill you, like it has several hundred others." Probably the FDA won't do that, but it doesn't seem farfetched to think that the warnings might be beefed up a bit more.
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