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Pradaxa is a blood-thinner used to help reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. Atrial fibrillation, or A-fib, is the most common type of irregular heartbeat. Symptoms include palpitations, fainting, chest pain, or even congestive heart failure. A-fib can also cause blood to pool in a storage chamber of the heart, leading to the possibility of a clot traveling to the brain, thereby causing a stroke.
People with A-fib often take a blood thinner to protect them from the risk of stroke, since the risk of stroke in A-fib patients can be up to 5 times higher, depending on other health factors.
Traditionally, there have not been many options to treat A-fib. For over 60 years, the only prescription available was the anticoagulant warfarin, but it comes with its own set of problems, such as risk for brain hemorrhages and serious bleeding. It also requires very close monitoring by doctors.
In October of 2010, the medical community greeted the FDA approval of Pradaxa with excitement. Finally doctors had an alternative to treat A-fib. But in two short years, that excitement has waned.
In 2011, more deaths were reported to the FDA due to Pradaxa than to any other drug on the market.
When not taken properly, Pradaxa increases the risk of stroke, serious bleeding, and blood clots, especially in patients with poor kidney function. This is a particular problem because unlike warfarin, Pradaxa claims not to need close monitoring. Therefore any improper use can turn something as simple as a minor fall into a serious bleeding event.
Which leads to the other major problem with Pradaxa: there is no reversal agent for it. If a major bleeding event does occur, then there is nothing that doctors can do to stop it. Warfarin might have bleeding problems as well, but it does have a reversal agent that can help stop life-threatening bleeding.
Proper kidney function is critical to the proper functioning of Pradaxa. Most doctors fail to test their patients for kidney function before prescribing Pradaxa, but 80% of the drug is excreted in the kidneys. Weak kidneys lead to unsafe levels of the drug building up in the bloodstream, leading to life-threatening problems. Gastrointestinal bleeding also raises the risk for problems with Pradaxa.
Bleeding is the most serious concern of Pradaxa. The following are signs and symptoms to watch for:
You are at a higher risk of dangerous bleeding if you take Pradaxa and:
The FDA approved Pradaxa to reduce the risk of stroke and blood clots in patients with A-fib in October of 2010. In December of 2011, it issued a safety announcement, stating its intentions to conduct a safety review of Pradaxa given the number of incidents of deaths reported.
The investigation will look into whether Pradaxa’s current label is adequate with regards to potential bleeding, since it claims that rates of bleeding with Pradaxa and warfarin are the same. The FDA will assess whether post-marketing data reveals that Pradaxa users are at an increased risk of bleeding fatalities in comparison to alternatives, such as warfarin.
The FDA also states the following: “At this time, the FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”
If you have been injured by Pradaxa or any other drug, contact a Pradaxa attorney at Kirkendall Dwyer LLP today. The sooner you call us, the more we can do to help you. Remember that your case review is free, and that our attorneys work on a strictly contingent fee basis. We don’t see a dime until you do.