Joel,
<<As far as I know astemizole carries the same risk as terfenadine. Any idea
why the FDA didn't also require astemizole to be withdrawn?>>
As someone who has followed this Seldane thing as a journalist, I'd suggest
that the answer to this question is not in your PDR but in your Wall Street
Journal: astemizole does not have the same regulatory history as Seldane, nor
is there a brand-new version of it that is (supposedly) free of the safety
risk from the interactions reported over the past few years.
As with most FDA actions of this magnitude, there is a broad lesson allegedly
being taught here which is supposed to resonate throughout the business. I'm
sure the agency expected the company to drop Seldane or replace it with the
new formula. The notion that the older, less safe drug would stay on the
market probably rankled FDA too much--especially since the Seldane
interaction has been the subject of several media reports, most recently a US
News cover story about all the pharmacies that still fill scripts for Seldane
and the drugs that interact with them.
anyway,
stephen
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