What is Pradaxa?
Pradaxa (Dabigatran) is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant (”blood thinner”) medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
History of Pradaxa
The FDA approved of the use of Pradaxa less than 2 years ago in October 2010. Several intense and fatal side effects have been associated with the use of Pradaxa and include:
- Severe Bleeding
- Gastrointestinal Bleeding
In 2011 the FDA announced a plan to look into reports that Pradaxa is considerably more dangerous than another drug in the same class (blood thinner), warfarin. The FDA wanted to see whether the serious side effects were occurring at higher rates than they were at they initial clinical trials approved by the FDA.
On March 6,, 2012, The Journal of Neurosurgery discussed a case where an elderly man entered an emergency room due to excessive bleeding caused by Pradaxa. Unlike warfarin, a drug similar to Pradaxa, whose anti-coagulant effects can be reversed with vitamin K injection, Pradaxa has no such reversal agent, creating a far higher risk.
On June 6, 2012, The Philadelphia Inquirer reported Pradaxa led all medications reported to the FDA when it came to cause of death, killing 500+ people in 2011. Warfarin was the cause of only 72 deaths in 2011.
As of June 25, 2012, the FDA has not required a “black box label” on Pradaxa. A black box label is the strongest warning that the FDA requires. However, in January 2012, the FDA did require an update on the bottle increasing the consumer warning about potential side effects of taking Pradaxa.
As of June 25, 2012, 21 cases involving Pradaxa have been filed across the country against drug manufacturer Boehringer Ingelheim. There is a motion being considered on July 26, 2012 to determine whether these cases should be consolidated in the U.S. District Court for the South District of Illinois, the motion seems likely to pass. Many family members continue to bring lawsuits on behalf of injured or deceased loved ones, and this trend seems likely to increase moving forward.
Contact an experienced Pradaxa Lawyer Today
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate injuries resulting from the risks of Pradaxa. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using Pradaxa. If you or a loved one has been injured as a result of Pradaxa, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog