While Pradaxa (Dabigatran) did not gain U.S. FDA approval until October of 2010, it became the subject of a New Zealand investigation in September, 2011, after five elderly patients died from severe internal bleeding. The relatives of those patients noted that adverse side effects began when their loved ones were switched from Warfarin to Pradaxa (Dabigatran). Infections set in following a swift deterioration of the overall condition of these five people. This New Zealand report came soon after Japanese officials asked Pradaxa (Dabigatran) manufacturer, Boehringer Ingelhem, to notify doctors of the potentially fatal bleeding risks associated with Pradaxa (Dabigatran), most particularly in elderly patients.
Pradaxa (Dabigatran) is a thrombin or blood clot inhibitor which stops clots from forming while treating patients with heart valve problems or atrial fibrillation who are at a significantly elevated risk of stroke. While negative effects of warfarin can be quickly counteracted by administering doses of Vitamin K in the event of abnormal bleeding, no such “antidote” exists for Pradaxa (Dabigatran). Although the initial clinical trial which followed over 18,000 people who were taking Pradaxa (Dabigatran) showed a 35% increase in effectiveness of reducing stroke risk over those taking Warfarin, serious side effects showed up quickly following FDA approval.
Cause for Concern
The serious side effects which can lead to death include intra-articular or pericardial bleeding, hemorrhagic stroke, bleeding in the brain or other subdural bleeds. Boehringer has acknowledged that Pradaxa (Dabigatran) has been associated with over 250 deaths over the past twenty-four months due to excessive internal bleeding. In the short amount of time Pradaxa (Dabigatran) has been on the market, it has generated more consumer complaints through the FDA’s MedWatch than over 98% of other drugs currently on the market. If you or a loved one who is currently taking Pradaxa (Dabigatran) experiences any type of severe or uncontrolled bleeding from a cut, frequent or severe nosebleeds or bleeding from the gums, unusually heavy menstrual bleeding, pink or brown urine, red, black or tarry stools, unexplained bruises which increase in size over time or coughing or vomiting blood you should immediately consult your physician.
Do I Have a Lawsuit?
Of course the issue of whether or not you have a lawsuit as a result of Pradaxa (Dabigatran) use will depend on the specific circumstances surrounding your Pradaxa (Dabigatran) use. The original RE-LY clinical trial which the FDA approval was based on showed that over 16% of all people taking Pradaxa (Dabigatran) experienced bleeding, over 3% experienced serious bleeding, nearly 2% experienced life-threatening bleeding, .3% experienced life-threatening bleeding in the brain and over 17% required emergency surgery for major bleeding somewhere in the body. Manufacturers of drugs and medical devices are responsible for unsafe drugs or devices which cause harm. If you have been injured by Pradaxa (Dabigatran) you may have a valid claim and be able to be awarded a settlement to cover medical expenses and lost wages as well as damages for emotional pain and suffering which was due to taking Pradaxa (Dabigatran).
The family of a Tennessee woman has filed a wrongful death lawsuit against the manufacturer of Pradaxa (Dabigatran), claiming Boehringer failed to adequately warn patients about the risks associated with their new blood-thinning drug. This lawsuit states that Pradaxa (Dabigatran) was prescribed for Nancy Brummett for long-term treatment of atrial fibrillation. Some two months after Mrs. Brummet began taking Pradaxa (Dabigatran) she was hospitalized with a massive gastrointestinal bleed and died less than three months after first taking Pradaxa (Dabigatran). The wrongful death lawsuit alleges Boehringer created a defective product which is not only no safer than Warfarin, but also lacks an antidote or reversal agent.
This complaint—which is believed to be only the first of many—also claims Boehringer should have placed a warning on their drug stating there was no quick way to manage a potential bleed in the body, and that the manufacturer further failed to adequately warn doctors and patients about potential Pradaxa (Dabigatran) risks. To find out whether you can instigate a lawsuit against Pradaxa (Dabigatran), you should contact a highly experienced products liability attorney who can more fully explain your potential case against the manufacture of Pradaxa (Dabigatran).
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