Boxed warnings on a drug's label don't carry skulls and crossbones, but they can sometimes be a death sentence in the revenue department. The Food and Drug Administration reserves the box for only the most severe warnings, which are often life-threatening side effects.
So it came as a bit of a surprise to me when the FDA slapped a black-boxed warning on Bristol-Myers Squibb
How much will the boxed warning hurt sales? In theory, not at all since the availability to test was already on the label. In reality, there were doctors not ordering the test; that's the reason the FDA wanted the availability highlighted. If doctors increase their usage, some additional patients screened for the genetic variation won't end up taking the drug. The genetic difference occurs in 2% to 14% of individuals depending on their racial background.
Another issue for Bristol and Sanofi is that drugs with boxed warnings have stricter advertising requirements, including a ban on reminder ads, which contain the name of the drug, but don't say what it does.
So who's poised to pick up those patients that can't benefit from Plavix? Eli Lilly's
Bristol and Sanofi are trying to milk as much out of Plavix as they can before it goes off patent in a few years. This new boxed warning may slow the stream just a bit, but with a bucket as full as it is ($6 billion and counting), the new warning shouldn't be too hard to deal with.
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