Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Pradaxa Increases GI Bleeding But Not Heart Attack Risk, Medicare Data Show

This article was originally published in The Pink Sheet Daily

Executive Summary

Higher incidence of gastrointestinal bleeding among the Medicare population contrasts with findings from an earlier Mini-Sentinel study of dabigatran and bleeding, but FDA said the disparity in results may reflect the age differences in the populations examined.

You may also be interested in...



Pradaxa Bleeding Risk Gets Deeper FDA Scrutiny In Mini-Sentinel Project

A 2012 Sentinel study didn’t find any problems, but FDA wants a closer look now that the dataset has grown.

FDA Chalks Up Pradaxa Safety Scare To “Stimulated Reporting”

In a New England Journal of Medicine editorial, FDA officials stress value and safety of Boehringer Ingelheim’s novel anticoagulant Pradaxa, which is struggling amid highly publicized reports of bleeding.

Mini Sentinel Alleviates FDA Concern Over Pradaxa Bleeding Issue

Data from the pilot program a “driving factor” in the agency’s decision against changing its recommendations for the blood thinner following reports of increased serious bleeding events.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077210

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel