Pradaxa Internal Bleeding
Pradaxa was the first prescription drug approved by the FDA for treatment of atrial fibrillation (AF) since the 1950s. Previously, doctors and AFib patients relied on warfarin to prevent stroke. Both Pradaxa (dabigatran etexilate) and warfarin are anticoagulants, or blood thinners, and as such, both carry a known risk for leading to serious bleeding problems. When Pradaxa was approved, many doctors believed a safer and simpler alternative to warfarin had been discovered, and hundreds of thousands of people switched to Pradaxa in its first year on the market. However, post-market reports of Pradaxa internal bleeding deaths have been higher than expected. A heightened risk of internal bleeding has prompted the FDA to add a new warning to the prescription's packaging, and to initiate a new study to determine whether Pradaxa should even be used by the public. This page offers a thorough explanation of the uses and dangers of Pradaxa.
How Pradaxa Works
Atrial fibrillation (AFib) is a heart condition in which the heart beats irregularly. Specifically, the upper chambers of the heart, known as the atria, beat rapidly and chaotically, out of sync with the ventricles, the lower chambers of the heart. This particular type of heart arrhythmia causes blood to pool in the atria, which creates a risk for the development of blood clots. A blood clot that makes its way to the brain, or an embolus, is particularly dangerous. An embolus is a blood clot that becomes lodged in a narrow brain artery, cutting off blood supply to the brain and leading to a disabling and life-threatening embolic stroke. Over 2 million Americans have been diagnosed with atrial fibrillation, and their risk of stroke is up to seven times greater than the risk of stroke for other Americans.
Pradaxa is an oral anticoagulant, or blood thinner. It works by inhibiting thrombin, a naturally occurring enzyme in the blood that is essential to blood clotting functions.
Doctors prescribe blood thinning drugs to patients with atrial fibrillation in order to reduce the risk of embolic stroke. For many decades, doctors have relied on the drug warfarin to help prevent stroke in patients with AFib. Taking any blood thinner puts a person at some risk of bleeding problems, but when Pradaxa was released, early clinical studies showed that researchers believed it was more effective at preventing stroke and no more dangerous than warfarin. Adverse event reporting since Pradaxa was released has shown that Pradaxa internal bleeding deaths are more common than anticipated, and many doctors are now wondering whether they should be prescribing Pradaxa at all.
Pradaxa Internal Bleeding Side Effects
While Pradaxa is effective at lowering the risk for stroke in patients with AF, the accompanying dangers are far too serious to be ignored. Data collected on Pradaxa since it was released for public use in the United States reveal two major problems with Pradaxa. The first is that Pradaxa internal bleeding events have proven to be far more common than the FDA originally expected. Bleeding problems were known to be a small risk for people taking blood thinners, but bleeding events that have led to Pradaxa internal bleeding deaths are even more common than early research projected.
The second problem with Pradaxa that complicates matters even more is that the drug has no known antidote. Once Pradaxa internal bleeding starts, doctors have no dependable method for getting the bleeding to stop. Thus, a minor accident can result in serious damage or death for a patient taking Pradaxa. In this sense, warfarin is superior; a simple injection of Vitamin K cancels the drug’s effect, allowing blood clots to form to stop the bleeding.
Pradaxa Internal Bleeding Deaths
To date, several Pradaxa internal bleeding lawsuits have been filed based on cases where a minor accident resulted in uncontrollable bleeding and death. As of October of 2011, Boehringer Ingleheim confirmed that 260 Pradaxa internal bleeding deaths had taken place throughout the world since March of 2008. Based on Pradaxa internal bleeding lawsuits and adverse event reporting, the FDA started an investigation into Pradaxa dangers on December 7, 2011. Safety advisories regarding Pradaxa internal bleeding risks have been issued in Japan and Australia. In January of 2012, the FDA required Boehringer Ingleheim to add more information to the drug's label about the danger of serious and deadly bleeding, reading, "Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding". But no Black Box warning was added, and despite the accumulating number of serious problems with Pradaxa, the FDA still recommends that patients continue to take the drug. We are still awaiting the results of the FDA's study of Pradaxa's dangers.
A recent and highly-publicized case of a Pradaxa internal bleeding death was detailed in the Journal of Neurosurgery in March of 2012. This was a case of an elderly man who took a minor fall, which developed into uncontrollable bleeding. He arrived at the hospital conscious and alert, and doctors watched as his brain functioning slipped away over the course of mere hours. Because he was taking Pradaxa, doctors were unable to stop his internal bleeding and the man died.
Other side effects of Pradaxa include gastro intestinal upset and bleeding, and a small risk of heart attack. People who are over 75, who have other diseases associated with a bleeding risk, and who have liver problems are at particular risk for developing Pradaxa internal bleeding.