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FDA grants orphan drug status to Factor Xa inhibitor antidote

EngMac profile image
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Website for article: healio.com/hematology-oncol...

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EngMac
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Mrspat profile image
Mrspat

Thank you for keeping across all of the science stuff.

I'm aware of court cases in the US about Pradaxa particularly. However, are there any documented cases in the UK of people on NOACS suffering major bleeds, either through trauma or otherwise and the outcomes?

CDreamer profile image
CDreamer in reply toMrspat

Good question.

Don't know but when I was on Pradaxa I talked to my Docs who all said that the U.S. cases were in the early days and were mainly due to elderly people being given a high dose and only once a day, The dosage was then reduced for elderly people and those with kidney impairment and the dose switched to x 2 a day. I believe the incidence of significant bleeds then reduced dramatically.

There were also an huge nos of reports of minor bleeds who sued through a class action, which of course gave the drug the notoriety. It's a while ago now so I couldn't give you the links, but I researched it very carefully before I started to take it.

in reply toCDreamer

Thanks for sharing this info, you have given some reassurance about Prodaxa

Finvola profile image
Finvola

Thank you for the link - good news for NOAC's and we who take them. :)

rosyG profile image
rosyG

Thank you- wonder when we might find it approved in the Uk

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