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Pradaxa Risk of Internal Bleeding

Today, over 1,800 lawsuits have been filed in federal court by patients who used Pradaxa (dabigatran) and suffered from uncontrollable internal bleeding. However, just a little over three years ago the drug was thought to have great promise for people diagnosed with non-valvular atrial fibrillation.

On October 19, 2010, Albert Ros shared the excitement of many patients at the release of Pradaxa because, unlike its counterpart warfarin (Coumadin), it didn’t require regular blood monitoring and a change in diet. “This is a special moment which exemplifies innovation in modern medicine. We are thrilled that the FDA’s approval of Pradaxa will bring a novel medicine to patients with non-valvular atrial fibrillation,” said Albert Ros, the president and CEO of Boehringer Ingelheim Pharmaceuticals, Inc., in a press release.

Following FDA approval, thousands of people began using Pradaxa instead of warfarin. As the prescriptions for dabigatran mounted, so did the reports of uncontrolled bleeding events. In May of 2012, in the report “Quarterwatch”, the Institute for Safe Medication Practices released data from the third and fourth quarters of 2011 indicating that Pradaxa users reported 3,781 serious uncontrollable bleeding incidents, which included 542 fatalities/pradaxa/. While warfarin users documented cases were more than 30 percent lower with only 72 deaths.

Pradaxa bleeding events spark investigation

In August 2011, the Japanese Ministry of Health, Labor, and Welfare issued a safety advisory warning of possible adverse effects for anyone taking Pradaxa. According to advisory notes, there had been 81 patients who experienced serious side effects since Pradaxa’s release, which included cases of gastrointestinal bleeding. At that time, it was believed that since Pradaxa was made available in Japan, in January 2011, it had been used by roughly 64,000 patients. According to Dr. Reinhard Malin, the spokesperson for Boehringer Ingelheim in Japan, factors such as age, low body weight, renal impairment, and comedication were probable contributing factors to bleeding risks for Japanese patients.

Researchers for the Therapeutics Initiative of the University of British Columbia – a Canadian medical watchdog group – reviewed the study performed by the RE-LY on Pradaxa prior to FDA approval and determined that RE-LY authors withheld information about adverse effect events. In the RE-LY study, it was reported that the only adverse effects “significantly more common” with Pradaxa than warfarin was indigestion.

The study by RE-LY – funded by the Pradaxa manufacturer – was pivotal to Pradaxa getting FDA approval in the U.S. as well as approval in Europe, Canada, and Japan. Following the Therapeutics Initiative review, a member of the team contacted both the RE-LY authors and Boehringer Ingelheim, but they declined to comment on the findings. The RE-LY study researchers finally released additional information, which included reports of 69 major hemorrhages, after the FDA requested they review their records to address the allegations of “underreported” adverse events.

In early 2012 an audit of internal bleeding events was done in collaboration with the Heaimatology Society of Australia and New Zealand, after hematologists raised concerns about Pradaxa. In a two-month period, the panel determined there were significant numbers of bleeding incidents. As a result of their study, it was emphasized that those prescribing Pradaxa need to be properly educated as to the limitations of the drug. Specifically, any patients with impaired renal function or low body weight should be carefully evaluated to determine the risks versus the benefits of dabigatran use.

Lack of a reversal agent complicates Pradaxa bleeding events

Dabigatran works by blocking thrombin, a blood enzyme needed in the clotting process. What makes Pradaxa such a high risk in event of bleeding is there in no known antidote to counter the presence of the drug in the blood. Patients who take Pradaxa are at high risk for uncontrollable bleeding events, including internal hemorrhages, especially if the person is injured in an accident or a fall, or if he needs emergency surgery. As a result of the escalation of severe Pradaxa bleeding episodes that sometimes end in death, there have been a large number of lawsuits filed against the manufacturer.

Possible antidote for Pradaxa

In November 2013, researchers released data from the first phase of a study involving an experimental antidote for Pradaxa. The results of the study showed the antidote “worked immediately and completely.” Although still in the early stages, “these are absolutely exciting findings,” said Dr. Stephan Glund, a research executive at Boehringer Ingelheim Pharmaceuticals.

The study involved 150 healthy volunteers. The antidote works by capturing Pradaxa in the bloodstream with a fragment of a monoclonal antibody — a protein created in living cells. The implications of the study and the new drug could be far-reaching for the manufacturer of Pradaxa who faces widespread criticism for failing to clearly define the serious side effects and risks of its blood thinning medication. However, it may be years before the Pradaxa antidote is available for public use.

Dangerous side effects fuel Pradaxa litigation

Anyone who has experienced the serious side effects of Pradaxa, such as uncontrollable internal bleeding may be eligible to file a lawsuit against the manufacturer, Boehringer Ingelheim, to demand damages. Families of victims may also be eligible.

Due to the overwhelming amount of wrongful death and product liability claims, the Pradaxa MDL – mulitdistrict litigation – was formed in the Southern District of Illinois to streamline pretrial processes and discovery. Individuals who have been injured after taking dabigatran are encouraged to contact an experienced attorney, who can establish grounds for recovering compensation in a Pradaxa lawsuit.

  1. Monitoring FDA MedWatch Reports Anticoagulants the Leading Reported Drug Risk in 2011 ,
  2. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non Non-Valvular Atrial Fibrillation,
  3. Deaths Prompt Dabigatran Safety Advisory in Japan,
  4. Reported Problems with Pradaxa,
  5. Bleeding Risk with Dabigatran in the Frail Elderly,
  6. Pradaxa antidote works fast, completely in small trial,