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Dabigatran (Pradaxa) safety update: Information for consumers

Safety advisory

23 May 2013

On 8 February 2013, the TGA published safety information for consumers regarding Pradaxa (active ingredient dabigatran).

The TGA has updated that information below, including details of:

  • advice regarding repackaging Pradaxa capsules
  • two safety reviews that have now been completed.

Pradaxa is an oral anticoagulant medicine - sometimes referred to as 'blood thinners'.

It is used for the prevention of clots in the legs after total hip or knee replacement surgery and to prevent stroke and other blood clots in people with atrial fibrillation (AF) - a commonly occurring abnormal heart rhythm.

As with all medicines, there are benefits and risks associated with the use of Pradaxa. If you have been prescribed Pradaxa, your doctor has weighed the risks of your taking this medicine against the expected benefits.

Information for consumers

If you are taking Pradaxa:

  • Do not stop taking it suddenly or lower the dose without consulting your doctor. Stopping Pradaxa suddenly can increase your risk of stroke or may increase the risk of developing a blood clot in the legs after total hip or knee replacement.
  • See your doctor immediately if you notice bleeding, red or brown urine, or red or black bowel motions.
  • Remember to tell all doctors, dentists and pharmacists who are treating you that you are taking Pradaxa. Similarly, tell them what other medicines you are taking - especially aspirin, anti-inflammatory medicines and other blood thinners, such as clopidogrel and warfarin - including any that you get without a prescription from a pharmacy, supermarket or health food store.
  • Do not repackage Pradaxa capsules, for example in pill boxes. Pradaxa capsules should be stored in their original packaging (blister pack or bottle). Repackaging Pradaxa capsules increases the risk of exposure to moisture or humidity, which could have an impact on the medicine’s effectiveness.

Consumers can find further information in the Consumer Medicine Information for Pradaxa or in the Medicine Update published on the NPS MedicineWise website.

If you have any questions or concerns about using Pradaxa, ask your doctor.

Additional information for health professionals is also available on the TGA website.

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Safety review

One of the known risks associated with using any anticoagulants, including Pradaxa is the increased possibility of bleeding.

The TGA has completed two safety reviews of Pradaxa (one in August 2012 and the other in April 2013) and has consobtained expert advice from its Advisory Committee on the Safety of Medicines (ACSOM).

Both reviews found that, when used appropriately in the right patients, the benefits of using Pradaxa outweigh the risks. However, the reviews reinforced the importance of appropriate patient selection and particularly the need for doctors to carefully assess a patient’s risk factors for bleeding when making a decision to prescribe Pradaxa.

Risk factors for bleeding include patients:

  • being aged 75 years or over 
  • having moderate kidney impairment (your doctor will know how to determine your kidney function)
  • with certain conditions and situations, including those with a history of bleeding, those who have recently suffered from serious bleeding in the brain or stomach, those with an increased tendency of bleeding complications, and/or those who have an infection of the heart
  • taking other medicines, especially aspirin, anti-inflammatory medicines and/or other blood thinners, such as clopidogrel and warfarin.

Additionally, Pradaxa should not be taken by patients with prosthetic heart valves. Patients with artificial heart valves who are taking Pradaxa should contact their doctor.

Risk management

The TGA approves and regulates products based on an assessment of benefits against the risks.

All therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk.

The benefit-risk approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs.

Further information about how the TGA regulates, including the approach to risk management, is available on the TGA website.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to our monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.