EMA Asks for Clearer Warnings on Pradaxa Labels

May 25, 2012 — The largest health regulatory agency in the EU, the European Medicines Agency (EMA), is calling on Boehringer Ingelheim to update the labels on Pradaxa (dabigatran).

The EMA is concerned that the current labels do not clearly warn who should not take Pradaxa, or how a doctor should reverse the anti-clotting effects of Pradaxa when severe bleeding occurs. Despite the fact that Pradaxa has caused nearly 500 deaths from heart attacks and uncontrollable bleeding, the EMA continued to affirm that the benefits outweigh its risks.

The concerns of the EMA are not new, and yet Boehringer Ingelheim has not voluntarily updated the label on Pradaxa to include clearer risk information.

Many physicians have been concerned about the lack of an effective reversal-agent. Even minor bleeds have been fatal in Pradaxa patients, mostly because doctors do not have a fast way to reverse Pradaxa’s anti-clotting effects. Recently, an 83 year-old Pradaxa patient died from a minor bleed in his brain, which began after a fall. Only dialysis could have removed Pradaxa from his bloodstream, but it would have taken hours. The man died from a cerebral hemorrhage.

Another risk, highlighted in a study published by a group of doctors in New Zealand, found that many general practitioners were poorly informed about how to prescribe Pradaxa. The New Zealand doctors found that it was common for Pradaxa to be prescribed to high-risk patients — older people who had impaired kidney function. The doctors found high rates of life-threatening bleeding in this population. When the kidneys fail to remove Pradaxa from the bloodstream, the drug can build up to toxic levels, which significantly increases the risk of fatal bleeding. Other studies have also found that elderly females have a higher risk of deadly Pradaxa bleeding.

Despite these well-known risks, Pradaxa has largely been hailed as a godsend. It is the first alternative to Coumadin (warfarin), which has been used to prevent strokes associated with atrial fibrillation for more than 50 years. Warfarin is notoriously problematic, difficult to administer, and associated with high rates of bleeding and complications. One benefit is that it can be reversed with a dose of Vitamin K, and doctors know what to expect when they prescribe it to new patients. Pradaxa, on the other hand, has no effective reversal agent. It has also caused more than 459 deaths.

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