Pradaxa Bleeding a Risk to the Elderly

In a letter to the editor of the New England Journal of Medicine, a group of New Zealand doctors raised questions about the safety of dabigatran (Pradaxa in the United States) when given to elderly patients.

The doctors, Paul Harper, M.D. of Palmerston North Hospital, Laura Young, M.B., Ch.B. of Auckland City Hospital, and Eileen Merriman, M.B., Ch.B. of North Shore Hospital conducted a study in collaboration with the Haematology Society of Australia and New Zealand.  Over the course of a 2 month period, researchers noted 78 episodes of bleeding in dabigatran patients, with 12 of these characterized as “episodes of major bleeding”.  The doctors found that four factors could have contributed to these internal bleeding episodes:

  • Prescriber error
  • Impaired renal function
  • Patient age
  • Complications from the lack of a reversal agent

The doctors raised concerns about the potential risks of dabigatran, especially as associated with the lack of a reversal agent.  Poor renal health is another factor that may increase the risk of dabigatran bleeding.  As more than 50% of patients with atrial fibrillation who are over the age of 80 years are diagnosed with moderate renal failure, this is a factor that cannot go ignored.

In their letter, the researchers call for additional post market surveillance and reporting related to dabigatran and Pradaxa side effects so that officials will be able to identify groups whose risk factors may not have been taken into account in a clinical trial setting.  In conclusion, the doctors call for careful evaluation of the risks and benefits of treatment with dabigatran before prescribing it to patients, especially patients who are over the age of 80 and/or show signs of renal impairment.

Contact a Dangerous Drug Lawyer

If you or someone you love has suffered from internal bleeding after taking Pradaxa or another blood thinner, you may be entitled to seek compensation in a dangerous drug lawsuit.  An experienced product liability lawyer can help you weigh your options in a free legal consultation.

March 6, 2012 | Tags: Dangerous Drugs, Pradaxa

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