Value through Innovation25 February 2015

Pradaxa safety information for patients, doctors, families and carers

Further to a recent article which has appeared in the British Medical Journal (BMJ) concerning our medicine Pradaxa, we think it’s important to comment as follows:
Atrial Fibrillation (AF) is a heart condition that causes an irregular heart beat and affects around 1million people in the UK1. AF is linked to an increased risk of stroke because it can lead to the formation of blood clots in the heart, which can break away and block important brain vessels2. AF increases the risk of stroke by up to five times1.

Our medicine, like all anticoagulants, thins the blood and therefore lowers the chance of blood clots caused by AF forming in your body2 which could lead to a devastating and potentially fatal stroke. All blood thinning medicines, from aspirin to warfarin and the new generation of oral anticoagulants, can increase the risk of bleeding2. However, clinical trials and regulatory assessments have shown that the benefits of our medicine outweigh the risks.

Dr Charles De Wet, Medical Director for Boehringer Ingelheim UK says “Patient safety is at the forefront of everything we do and we are deeply concerned that misleading and imbalanced media coverage could compromise the health and safety of people who may benefit from important new medicines like ours. AF related stroke kills more than one person every hour in the UK. It is our sincere belief that our medicine contributes to reducing the severe consequences of this disease”.

It is very important that if you have any questions you do not stop taking your medicine without consulting your doctor as this could greatly increase your risk of stroke.

For media enquiries please contact the press office on 01344 741155 or email pressoffice.bra@boehringer-ingelheim.com

References
1.http://www.bhf.org.uk/heart-matters-online/october-november-2012/medical/focus-on-atrial-fibrillation.aspx accessed 17 July 2014
2.http://www.patient.co.uk/health/atrial-fibrillation-leaflet accessed 17 July 2014

Job No: UK/DBG-141188
Date of preparation: July 2014

 

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Remember, if you have any concerns; please do not stop taking it without first speaking to your doctor.

If you are taking or being prescribed a Boehringer Ingelheim medicine and experience any adverse events, you should immediately report these to your doctor, or to another healthcare professional (such as a nurse or carer).

Adverse events can also be reported via the Drug Safety team at Boehringer Ingelheim on 01344 741346 or email PV_local_UK_Ireland@boehringer-ingelheim.com. You can also contact the MHRA through its Yellow Card reporting system at www.mhra.gov.uk/yellowcard.

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