Welcome!

News Feed Item

/R E P E A T -- Advisory - Pradaxa (dabigatran, previously called Pradax): not to be used in patients with artificial heart valves/

OTTAWA, Dec. 21, 2012 /CNW/ -

The issue:

Health Canada is advising health care professionals and the public that, based on new information, the blood-thinning drug Pradaxa is not to be used in patients with artificial heart valves (also known as prosthetic heart valves) due to the risk of strokes, bleeding, heart attacks, and blood clots forming on the artificial heart valves.

Who is affected:

Patients who are taking Pradaxa and have an artificial heart valve.

What patients should do:
  • If you are taking Pradaxa and have had an artificial heart valve replacement, talk to your health care professional as soon as possible to determine the most appropriate alternative treatment.
  • Do not stop using Pradaxa or other anticoagulants without guidance from your health care professional.  Stopping anticoagulants suddenly may increase your risk of blood clots or a stroke.
  • Report any adverse reactions (side-effects) you may have experienced to your health care professional.

What health care professionals should do:

  • Pradaxa is contraindicated now in patients with artificial heart valves requiring anticoagulant treatment due to their valvular status.
  • Consider promptly transitioning any patient with an artificial heart valve who is taking Pradaxa to another appropriate anticoagulant medication.
  • Please note that the information in the associated Notice to Hospitals supplements the information on this issue (dated December 21, 2012) provided by Boehringer Ingelheim (Canada) Ltd., the manufacturer of Pradaxa.

What Health Canada is doing:

Health Canada is working with the manufacturer of Pradaxa, Boehringer Ingelheim (Canada) Ltd., to update the Canadian Product Monograph for Pradaxa to strengthen the present warning that the drug should not be prescribed to patients with artificial heart valves. The Product Monograph for Pradaxa currently recommends against the use of Pradaxa in patients with artificial heart valves.

Background:

As per the Canadian Product Monograph, Pradaxa (dabigatran etexilate) is approved for the prevention of blood clots in patients who have undergone hip replacement or total knee replacement surgery, and for the prevention of stroke and blood clots in the body in patients with atrial fibrillation (irregular heart beat) in whom a medication to prevent blood clotting is considered appropriate.

A recent European clinical trial involving patients with a type of artificial heart valve was terminated early due to significantly more adverse events for patients using Pradaxa.

Additional information for health care practitioners:

  • An interim analysis of the study results showed a statistically significant excess of thrombosis events in the Pradaxa treatment arm compared to the warfarin treatment arm, including valve thrombosis, stroke and myocardial infarction in patients with recent  mechanical heart valve placement receiving dabigatran (p=0.033 Fishers's Exact Probability).
  • Pradaxa will be contraindicated for use in patients with artificial heart valves requiring anticoagulant treatment due to their valvular status.
  • Health care professionals should promptly transition any patient with an artificial heart valve who is taking Pradaxa to another anticoagulant medication, such as warfarin.
  • Health care professionals are reminded to strictly follow the recommended conditions of use for Pradaxa outlined in the Canadian Product Monograph.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related Health Canada Web content:

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Également disponible en français

SOURCE Health Canada

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, highlighted the current challenges of these transformative technologies and shared strategies for preparing your organization for these changes. This “view from the top” outlined the latest trends and developments i...
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, paneli...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business...
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
SYS-CON Events announced today that GrapeUp, the leading provider of rapid product development at the speed of business, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market acr...
SYS-CON Events announced today that Ayehu will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara California. Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infras...
SYS-CON Events announced today that Datanami has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datanami is a communication channel dedicated to providing insight, analysis and up-to-the-minute information about emerging trends and solutions in Big Data. The publication sheds light on all cutting-edge technologies including networking, storage and applications, and the...
Artificial intelligence, machine learning, neural networks. We’re in the midst of a wave of excitement around AI such as hasn’t been seen for a few decades. But those previous periods of inflated expectations led to troughs of disappointment. Will this time be different? Most likely. Applications of AI such as predictive analytics are already decreasing costs and improving reliability of industrial machinery. Furthermore, the funding and research going into AI now comes from a wide range of com...
SYS-CON Events announced today that EnterpriseTech has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. EnterpriseTech is a professional resource for news and intelligence covering the migration of high-end technologies into the enterprise and business-IT industry, with a special focus on high-tech solutions in new product development, workload management, increased effi...
In this presentation, Striim CTO and founder Steve Wilkes will discuss practical strategies for counteracting fraud and cyberattacks by leveraging real-time streaming analytics. In his session at @ThingsExpo, Steve Wilkes, Founder and Chief Technology Officer at Striim, will provide a detailed look into leveraging streaming data management to correlate events in real time, and identify potential breaches across IoT and non-IoT systems throughout the enterprise. Strategies for processing massive ...
SYS-CON Events announced today that SourceForge has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. SourceForge is the largest, most trusted destination for Open Source Software development, collaboration, discovery and download on the web serving over 32 million viewers, 150 million downloads and over 460,000 active development projects each and every month.
"Our strategy is to focus on the hyperscale providers - AWS, Azure, and Google. Over the last year we saw that a lot of developers need to learn how to do their job in the cloud and we see this DevOps movement that we are catering to with our content," stated Alessandro Fasan, Head of Global Sales at Cloud Academy, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We focus on composable infrastructure. Composable infrastructure has been named by companies like Gartner as the evolution of the IT infrastructure where everything is now driven by software," explained Bruno Andrade, CEO and Founder of HTBase, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organi...
SYS-CON Events announced today that Cloud Academy named "Bronze Sponsor" of 21st International Cloud Expo which will take place October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara, CA. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud com...