Pradaxa Lawsuit | Side Effects : Internal Bleeding, Internal Hemorrhaging, Bleeding
Have you or someone you care about suffered life-threatening internal bleeding or hemorrhaging side effects while taking Pradaxa? The defective drug lawyers at Parker Waichman LLP are currently investigating reports that some Pradaxa patients have experienced serious internal bleeding or hemorrhaging side effect episodes. In some instances, Pradaxa bleeding, internal bleeding / hemorrhaging side effects was not discovered in a timely manner, leading to death.
If you or someone you know experienced serious Pradaxa bleeding / hemorrhaging that might be associated with the drug, our defective drug lawyers want to hear from you today. We are currently offering FREE Pradaxa lawsuit consultations to all victims of Pradaxa bleeding / hemorrhaging side effects. To discuss your potential Pradaxa bleeding / hemorrhaging or other Pradaxa side effects lawsuit with an experienced defective drug lawyer, we urge you to contact us today.
Pradaxa Bleeding / Hemorrhaging Side Effects Reports
Pradaxa (dabigatran etexilate) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent blood clots in patients with atrial fibrillation.Symptoms of Pradaxa bleeding include:
- Unusual bruising or bleeding / hemorrhaging
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds
- Bleeding from the gums
- Frequent nosebleeds
- Joint pain or swelling
- Weakness and swelling of the arms, hands, feet, ankles or lower legs.
No Antidote For Pradaxa Bleeding
Pradaxa was brought to market with great fanfare, with its maker touting it as being safer than traditional blood thinners, like warfarin (brand names Coumadin, Jantoven and Marfarin). And it is true that Pradaxa will not react with certain foods the way warfarin will to increase the likelyhood of bleeding events. However, warfarin bleeding can be stopped via the administration of vitamin K. There is no antidote for Pradaxa bleeding at this time, making Pradaxa bleeding events potentially far more deadly.
Pradaxa Side Effects May Have Caused Patient Deaths From Bleeding / Hemorrhaging
In September 2011, Pradaxa became the subject of an investigation in New Zealand after as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding / hemorrhaging. Another 36 patients reportedly suffered bouts of serious internal bleeding / hemorrhaging. New Zealand media outlets reported that some families claimed the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in after their conditions had deteriorated to the point of hospital admission.
The New Zealand reports came weeks after regulators in Japan asked the maker of Pradaxa to notify doctors about potentially deadly bleeding / hemorrhaging in some Pradaxa patients. According to a letter sent to Boehringer Ingelheim by the country's health ministry, between March 14 and August11, 81 elderly patients taking Pradaxa suffered heavy bleeding / hemorrhaging, leading to five deaths. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa. Bleeding / hemorrhaging is also a side effect of older blood thinners, such a warfarin. But warfarin bleeding can be treated with vitamin K. There is no antidote available for bleeding caused by Pradaxa and similar drugs, known as direct thrombin inhibitors.
Large Study Finds Pradaxa Carries Greater GI Bleeding Risks Than Warfarin
The FDA has completed a study involving Medicaid patients that compared Pradaxa, which is made by Boehringer Ingelheim, to warfarin, both blood-thinning drugs. The study endeavored to understand the risk for ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death seen in people who take the medications. The research included data from more than 134,000 Medicare patients, 65 years or older.
The study revealed that, among new users of blood-thinning drugs, Pradaxa was tied to a lower risk of clot-related strokes, bleeding in the brain, and death; however, when compared to people who took warfarin, an increased risk of major gastrointestinal bleeding was seen in Pradaxa users. The MI risk was similar in both drugs and was consistent with Pradaxa’s clinical trial results.
This study was based on a significantly larger and older patient population than was used in the agency’s prior review of post-market data, and also used more sophisticated analytical methods for collection and analysis. The FDA has made no changes to the current Pradaxa label or recommendations for the drug’s use.
Pradaxa Lawsuit | Legal Help for Victims of Pradaxa Bleeding
If you or a loved one suffered serious Pradaxa bleeding / hemorrhaging while taking the drug, you may have valuable legal rights. To learn how our Pradaxa bleeding lawyers can help you file a Pradaxa Lawsuit, please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.