FDA to Review Pradaxa Internal Bleeding Reports

If you have been injured by Pradaxa, you may want to contact a lawyer for Pradaxa lawsuits in Texas. The FDA has received numerous reports of internal bleeding and hemorrhaging, and announced today that it will be reviewing these reports. There has been growing concern, after 256 cases of fatal internal bleeding were linked to Pradaxa, reported by the European Medicines Agency. 14 deaths in Japan have also been reported.

The FDA announcement warns physicians to use caution when prescribing Pradaxa, especially to elderly patients and people with poor kidney function. People with poor kidney function may not be able to effectively flush Pradaxa out of the bloodstream, leading to dangerously high levels of the drug. People with dangerously high levels of this drug in their bloodstream may bruise easily, or experience an internal hemorrhage that cannot easily be stopped. This can lead to death.

You can contact The Clark Firm, LLP for Pradaxa lawsuits in Texas. We offer a free case consultation. You may be entitled to compensation.

As the FDA mobilizes to review the safety of Pradaxa, it will need to compare the safety of this medication to its alternative, warfarin. Warfarin is another blood-thinning, anti-stroke medication that has been used for more than 50 years to prevent the blood clots that can cause a stroke. Warfarin is well-known to cause bleeding and hemorrhaging, and so physicians are less likely to report these events. Because bleeding events are under-reported, the FDA cannot simply compare the number of bleeding events caused by warfarin to Pradaxa.

In addition, bleeding caused by warfarin can be easily reversed with a dose of Vitamin K. Pradaxa, however, has no simple safety mechanism. It is particularly dangerous to patients when they must undergo an unexpected surgery, because the physician may have trouble controlling bleeding.

A recent study of Pradaxa linked the medication to numerous serious, life-threatening side effects. These side effects include internal bleeding, internal hemorrhage, cerebral hemorrhage, and death. The clinical trial was called the RE-LY Clinical Trial, and its findings were as follows:

• 16.4% of people taking Pradaxa experience bleeding
• 3.3% experience serious bleeding
• 1.5% experience life-threatening bleeding
• 0.3% experience life-threatening bleeding in the brain.
• 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
• Pradaxa triggers a 6% rate of major internal hemorrhages during each year of treatment

Many people who have been injured by a serious Pradaxa side effect are now contacting lawyers for Pradaxa lawsuits in Texas. It is possible that thousands of people have experienced internal bleeding and internal hemorrhage, and may be entitled to compensation for their injuries.

Pradaxa is one of the most popular anti-stroke medications in the world. Since its approval in October 2010, hundreds of thousands of people have taken this medication. The drug-maker, Boehringer Ingelheim, sold roughly 1.1 million doses within its first year, providing more than 371,000 people with anti-stroke medication.

Most of the people who were prescribed Pradaxa suffered from “atrial fibrillation,” which is when the heart beats irregularly. This can cause blood to pool in the upper chambers of the heart (or “atrium”). If this blood forms a blood clot, the heart might pump the blood clot into the body (called an “embolism”), which can become trapped in the heart, brain, lungs, or other major internal organ — causing a stroke.

Pradaxa belongs to a group of anti-blood-clot medications called “direct thrombin inhibitors,” which inhibit an enzyme in the blood that is necessary for clotting. Unfortunately, sometimes these blood-thinning medications work too well, and a person cannot form blood clots they need when they are experiencing a serious bleeding event. If the blood cannot clot, the person can bleed to death.

Need a Pradaxa Lawyer in Texas?

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