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Biotech / Medical : ARIAD Pharmaceuticals
ARIA 23.990.0%Feb 17 4:00 PM EST
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To: glass 0.5 full who wrote (2910)11/1/2013 4:15:35 PM
From: Biomaven1 Recommendation

Recommended By
scaram(o)uche

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You have to understand that this paper was submitted several months ago. They made some changes in the discussion, but that's about it.

Personally, I now expect there is a good chance Tasigna gets a black box warning on this issue as well. There again, nobody much noticed this pattern of side effects until someone focused on it. Partly these occlusive events are spread around the body and so they aren't that noticeable until there is a focus on them. These are all older patients, and so some amount of PAD is expected, and some significant amount is just not observed unless you specifically test for it or it becomes critical.

So this group of SAEs pretty much snuck up on everyone here, except perhaps for the FDA. Kudos to the FDA for the original Black Box and for following up here.

Peter
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