Pradaxa’s Serious Side Effects Concern Doctors

Pradaxa is an anticoagulant (used to prevent blood clots) that was designed to replace warfarin in the prevention of strokes in patients who suffer from atrial fibrillation.

Pradaxa has been linked to an increased risk of bleeding, a common side effect in anti blood clotting medications.

A new report suggests some doctors are concerned about the side effects of Pradaxa, which include increased risks of death due to bleeding or hemorrhaging.  Concerns have been raised regarding patients who are taking Pradaxa, who are at risk of uncontrollable bleeding episodes, even from the slightest fall, which can be fatal. There was a case involving a woman taking Pradaxa for atrial fibrillation, who sustained a fall on her kitchen floor. Less than 24 hours later, she had died from an intracranial hemorrhage that could not be stopped. The major problem with Pradaxa when compared to warfarin, is that there is no antidote for Pradaxa.  If a patient experiences severe bleeding while taking warfarin, vitamin K will immediately stop the hemorrhage. Nothing is available presently, to stop the bleed from Pradaxa, and the result is to bleed to death.

Manufactured by Boehringer Ingelheim, Pradaxa (dabigatran) was approved by the U.S. Food and Drug Administration in October 2010 as an alternative to warfarin, to prevent blood clots and strokes in people with atrial fibrillation.

By the end of 2011, a little more than one year after the blood thinning medication was approved for use in the U.S., the makers of Pradaxa acknowledged that there had been at least 260 deaths worldwide among people who suffered severe Pradaxa bleeding side effects.

A number of lawsuits have been filed against Boehringer Ingelheim, alleging that patients died as a result of using Pradaxa and that the manufacturer did not adequately warn about the risks associated with this drug.

In the first 12 weeks Pradaxa was on the market, more than 300 serious adverse events were reported to the FDA.  Within six months of reaching pharmacies and samples in doctor’s offices, the number of adverse side effects escalated to more than 900, including more than 100 deaths. By December 2011, the number of deaths reported in Pradaxa users reached over 500. The majority of these adverse effects involved internal bleeding or hemorrhaging. Not all adverse cases have been reported.

The Judicial Panel on MDL approved a plaintiff motion to have Pradaxa lawsuits consolidated in early August. At the time, there were just 21 lawsuits included in it.

In less than a month, more than 50 cases have been added to the newly formed Pradaxa Multidistrict Litigation that claims the blood thinner Pradaxa causes serious and fatal gastrointestinal bleeding and cerebral hemorrhaging and is no safer or more effective than its predecessor. According to a report from The Madison Record, a local legal journal, there are now 78 Pradaxa bleeding lawsuits included in the MDL currently in U.S. District Court.

That number is expected to grow considerably as more people realize the new blood thinner drug they are taking is actually putting them at a greater risk of suffering severe bleeding and death than warfarin, the drug that, for decades, was the standard for those people looking to avoid blood clots, which could lead to stroke and death.

Most people trust that when their doctors recommend a new medication for them, it is safe and they feel hopeful that their condition will improve. However, many pharmaceutical companies do not adequately test these drugs or their side effects.

As of today, Pradaxa has not been recalled and is still available for use. Why was this drug ever approved? The makers of Pradaxa claim their drug is more effective than Coumadin (warfarin) and therefore, worth the additional risks of bleeding even without an antidote.  I don’t know about you, but I think any comparable drug is better than the drug with increased risks of bleeding to death.

For more information, contact a Gacovino & Lake attorney at 1-800-246-HURT (4878).

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