Pradaxa approval?

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Does anyone know when the FAA will announce the status of Pradaxa approval?
Thanks.
 
I hear the members of the panel have apparently been named. Likely two more months...and late addition after OKC visit on the 5th: appproval is in DOUBT.
 
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I've gotten two emails in the past weeks showing new studies that pradaxa has higher incidence of heart attacks and other cardiovascular side effects. It's "good" for Afib but there's more they are learning about it as time goes on.
 
I rarely prescribe a new medication as I don't like surprises. I let other physicians experiment with their patients. The clinical trials used to get drug approval are actually fairly small.
 
The FAA will NOT approve Pradaxa. There have been a significant number of deaths related to this medication and the FAA has personally informed me directly that they will NOT approve this medication in the foreseeable future and / or until the sdie effects have been addressed by the manufacturer.

david
 
Was just informed today that Pradaxa has now won limited approval.
No valves
No stroke in the prior 6 months
Cannot exceed recommended dose
Have to be younger than 75.
 
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