Pradaxa Bleeding Risk: A Brief History of Death and Internal Bleeding
Pradaxa (dabigatran) is a relatively new blood thinner, which was just introduced in October 2010 as a replacement for Coumadin (warfarin). However, in the short period of time the drug has been on the market, an alarming number of deaths and serious bleeds have occurred from Pradaxa side effects, resulting in questions about why Pradaxa remains on the market and a growing number of individuals are pursuing a Pradaxa lawsuit as a result of the drug maker’s failure to adequately warn about the risk of complications.
The attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who have experienced internal bleeding or sudden death from Pradaxa. Below is a timeline of the brief Pradaxa history:
October 2010: Pradaxa (dabigatran) was approved for prevention of strokes due to atrial fibrillation. Immediately after it was introduced, Boehringer Ingelheim aggressively marketed the drug as superior to Coumadin (warfarin), an older blood thinner. However, almost right out of the gate there were signs of Pradaxa problems.
October 2010 to December 2010: During the last quarter of 2010 and the first three months Pradaxa was on the market, the FDA received more than 300 adverse event reports involving problems with Pradaxa. According to a review conducted by the Institute for Safe Medication Practices (PDF), most of these involved bleeding problems among elderly users, and the group noted that doctors began using Pradaxa off-label as a general blood thinner almost immediately after it was approved. This quick rise was a result of marketing efforts by the drug maker, which failed to provide accurate information to consumers and the medical community.
October 2011: In a letter published in the medical journal Therapeutics Initiative (PDF), researchers from the University of British Columbia poited out fundamental flaws in the clinical trials used by Boehringer Ingelheim to obtain FDA approval for the medication. Researchers indicated that the medication should not have been approved based on the faulty clinical trials, which were set up in a way that allowed bias and errors to creep into the results. The letter suggested that Pradaxa was too dangerous for many patients, and recommended that an audit of the clinical trials was necessary to look at irregularities in conduct, bias and some of the trial’s findings.
November 2011: In response to an inquiry by Japanese health offcials, Boehringer Ingelheim acknowledged that they were aware of at least 50 deaths from Pradaxa, mostly caused by bleeding complications. Although the drug maker indicated that this number was within the expected range, it agreed to launch an internal review of the safety of Pradaxa. The death toll was later adjusted to more than 260 Pradaxa deaths over the first year it was on the market.
December 7, 2011: The FDA issued a drug safety communication, indicating that it was evaluating post-marketing reports on the Pradaxa bleeding risks. The agency indicated that it will look to see if there is anything abnormal about the bleeding side effects of Pradaxa and whether it could pose an unreasonable risk for consumers, raising questions about whether a Pradaxa recall may be issued.
The FDA indicated that users should not stop taking Pradaxa without consulting with their doctor, and indicated that they should seek immediate medical treatment if they see signs of bleeding problems on Pradaxa, such as:
- Unusual bleeding from the gums
- Frequent nose bleeds
- Unusually heavy menstrual or vaginal bleeding
- Severe, uncontrolled bleeding
- Pink or brown urine (which may be signs of blood in the urine)
- Red or black stool that looks like tar (which may be signs of blood in the stool)
- Unexplained bruises that grow over time
- Coughing up blood or blood clots
- Vomiting blood or a substance that looks like coffee grounds (which may be a sign of internal bleeding)
January 2012: A study published in Circulation, the medical journal of the American Heart Association, suggested that the rate of heart attacks on Pradaxa may be higher than with warfarin. Researchers evaluated results of a prior clinical trial known as the RE-LY study, which compared Pradaxa and Coumadin (warfarin). Researchers found that the rate of heart attacks was slightly increased at both high doses and llow doses among patients being treated for stroke prevention.
January 2012 The Institute for Safe Medication Practices released another report, which evaluated the adverse event reports submitted to the FDA between January 2011 and March 2011. During the second quarter Pradaxa was available in the United States, the FDA continued to receive an increasing number of adverse event reports, with more than 932 serious adverse event reports involving Pradaxa were reported, including 120 deaths, 25 individuals who were permanently disabled, 543 hospitalizations and 505 reports involving bleeding with Pradaxa.
February 2012: According to a study published in the Journal of the American College of Cardiology, Pradaxa was found to increase the risk of bleeding events when compared with warfarin among patients treated with radiofrequency ablation of atrial fibrillation. Researchers from the University of Kansas Hospital and Medical Center found that 16% of patients treated with Pradaxa experienced bleeding complications and strokes, compared to only 6% of those given warfarin.
PRADAXA BLEEDING LAWSUITS
Unfortunately, the history of Pradaxa bleeding risk is still developing. As a result of the drug maker’s failure to adequately research the medication or warn about the bleeding risk, the Pradaxa lawyers at Saiontz & Kirk, P.A. are no longer reviewing potential lawsuits for individuals throughout the United States who have died or suffered serious bleeding complications.