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EMA Asks for Clearer Warnings on Pradaxa Labels

EMA Asks for Clearer Warnings on Pradaxa Labels

May 25, 2012 — The European Medicines Agency (EMA), the largest health regulatory agency in the EU, is asking Boehringer Ingelheim for clearer guidance on how to avoid bleeding risks and heart attacks associated with Pradaxa (dabigatran). The EMA affirmed that the benefits of Pradaxa outweigh its risks, despite hundreds of fatal bleeding events, but they were concerned that labeling about the risks was not clear enough.

The EMA is recommending an update to the label to provide stronger, clearer warnings about the risk of Pradaxa bleeding. The new labels should include information on who should not use Pradaxa, as well as advice on reversing the anti-clotting effects of Pradaxa when bleeding occurs.

Pradaxa is a new stroke-prevention medication, which works by inhibiting the formation of blood clots. Pradaxa is meant to be used by people who have atrial fibrillation, a type of irregular “fluttering” heart rhythm that can cause blood clots to form in the heart, which can then be pumped into the brain, causing a stroke. When Pradaxa entered the U.S. market a couple years ago, it was hailed as a godsend alternative to Coumadin (warfarin), a notoriously difficult and problematic anti-stroke drug that has been in use for more than 50 years.

As more and more people have started using Pradaxa, there has been increasing concern about its safety. One issue is that, unlike warfarin, Pradaxa has no easy reversal-mechanism — if a patient begins bleeding, only dialysis can remove Pradaxa from the bloodstream and stop its anti-clotting effects. The potentially deadly risks of fatal Pradaxa bleeding events was highlighted in the case of an elderly man who suffered a fatal cerebral hemorrhage after a minor fall.

Another issue, raised by doctors in New Zealand who studied Pradaxa bleeding events, is that general practice physicians were largely unaware of the risks of Pradaxa when the medication was first sold. The New Zealand researchers found that doctors were prescribing Pradaxa to high-risk patients, including elderly people with impaired kidney function. The risk of life-threatening bleeding increases significantly for people whose kidneys do not effectively remove Pradaxa from the bloodstream, leading to toxic high levels of the drug.

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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