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Pradaxa FAQ

Q: What is Pradaxa?

Pradaxa (dabigatran etexilate mesylate) is an anticoagulant medication used to treat cases of atrial fibrillation that aren't caused by a heart valve issue. Patients who suffer from the heart condition atrial fibrillation are at risk for blood clots and stroke. As a blood-thinner, Pradaxa helps prevent the development of blood clots and decreases the risk of stroke.

Q: When was Pradaxa approved?

In October 2010, Pradaxa's manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. obtained approval from the Food and Drug Administration (FDA) to distribute the drug in the United States. Since that time, Pradaxa has become a popular alternative to the long-used anticoagulant warfarin. Unlike warfarin, Pradaxa doesn't require regular monitoring tests or special dietary restrictions.

Q: What side effects are associated with Pradaxa?

Pradaxa's side effects include indigestion, stomach pain, heartburn, and nausea. In some cases, patients may experience an allergic reaction to Pradaxa. Symptoms of an allergic reaction may include rash, itching, and hives.

Q: Can Pradaxa cause internal bleeding?

Pradaxa has been associated with severe internal bleeding. In 2011, the FDA received reports of 2,367 cases of hemorrhaging along with reports of 542 deaths linked to Pradaxa. In 2012, the number of deaths linked to Pradaxa reportedly increased by 7 percent. According to FDA adverse reports, 582 Pradaxa users died in 2012 after taking the drug.

Q: Is there a reversal agent to stop bleeding caused by Pradaxa?

Until 2015, Pradaxa didn't have a direct reversal agent to stop bleeding. In some instances, dialysis was used to remove Pradaxa from a patient's blood. In other instances, there was no way to stop a Pradaxa patient's bleeding. In 2015, the FDA approved Praxbind, a reversal agent for Praxada.  

Q: Should patients with mechanical heart valves take Pradaxa?

According to the FDA, patients with mechanical heart valves shouldn't take Pradaxa. The FDA reached this conclusion after reviewing medical research involving patients with mechanical heart valves. In the study, one group of patients took Pradaxa, whereas another group took warfarin. The Pradaxa group had a higher rate of major bleeding in comparison to the warfarin group. In addition, 5 percent of the Pradaxa group suffered from strokes, while none of the patients in the warfarin group experienced a stroke.

Q: Should patients stop taking Pradaxa?

Discontinuing Pradaxa has been associated with an increased risk of stroke. Strokes are often debilitating and in some cases can result in death. As a result, it's extremely important that patients consult with their doctor before discontinuing use of the drug.

Q: Is there a new FDA safety assessment for Pradaxa?

In early 2014, the FDA commenced a new safety assessment regarding Pradaxa. The FDA's safety assessment will compare atrial fibrillation patients who are new users of Pradaxa to atrial fibrillation patients who are new users of warfarin. Health complications such as stroke and bleeding issues will be evaluated.

Q: Have any Pradaxa lawsuits been filed?

Currently, thousands of product liability lawsuits involving Pradaxa have been filed in the state and federal courts. Many of the lawsuits have been consolidated into a multidistrict litigation matter in the United States District Court for the Southern District of Illinois. In addition, the first Pradaxa bellwether trial is expected to commence in the latter half of 2014.

Q: Is the manufacturer liable for Pradaxa complications?

Under product liability law, drug manufacturers have a duty to ensure that their prescription drugs are safe for patients. Medications shouldn't be unreasonably dangerous. Nor should they carry product defects such as manufacturing defects, defective warnings, and design defects. If a medication is defective and unreasonably dangerous, the drug manufacturer can be held legally liable for any resulting injuries.

In the Pradaxa lawsuits, plaintiffs have alleged that the manufacturer Boehringer Ingelheim provided defective warnings about the potential risks for severe or fatal bleeding. Plaintiffs claim that if they had been properly warned about this risk, they wouldn't have taken Pradaxa. If a jury finds in favor of the plaintiffs, they could be awarded financial compensation for their injuries. A jury award typically includes damages for medical expenses, lost wages, and pain and suffering.

Q: What should I do if I've been injured by Pradaxa?

If you or a loved one has been harmed by Pradaxa, it's important that you seek medical treatment. Your doctor will be able to discuss your treatment options with you. In addition, you may want to consider speaking with an attorney.

Q: How can I get free legal advice about my injury?

If you believe you have been injured as a result of taking Pradaxa -- after getting medical attention -- you should seek legal expertise. If you're not sure whether you have a valid claim, consider connecting with a product liability attorney to receive an initial claim evaluation at no charge.

Next Steps
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