Injury Spotlight: Pradaxa Bleeding Dangers
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
The growing crisis involving the blood thinner Pradaxa can be described in one word – scary.
The Pradaxa fiasco has all the makings of another major pharmaceutical injury epidemic. First a little background on Pradaxa. This drug is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots. It is a huge money maker for manufacturer Boehringer Ingelheim, with Pradaxa sales of over $603 million in 2011 alone.
The problem is, Pradaxa can cause bleeding at a truly alarming rate, which can be serious and lead to death. And it is not an uncommon problem.
There have been 260 reports of fatal Pradaxa bleeding among patients worldwide. The Pradaxa bleeding deaths included 21 in Europe. There were at least 14 in Japan. However, there is an unknown number of Pradaxa bleeding deaths in the US. And the number is growing every week. What makes things even more alarming is that the reported deaths occurred within a very small window for such a large number of incidents, with the 260 figure of Pradaxa bleeding deaths occurring between March 2008 and October 31, 2011.
Pradaxa Injuries and Deaths
Update: Pradaxa tied for first place as the drug most linked to adverse event reports filed with the FDA in 2011. It is the highest risk of all drug treatments, reportedQuarterWatch, a non-profit drug monitoring organization. In 2011, the FDA received reports of 3,781 serious, harmful events. This also includes 542 deaths in the U.S. alone. Pradaxa surpassed all other drugs for negative reports involving hemorrhage, acute renal (kidney) failure and stroke.
Worldwide Reaction to Pradaxa Dangers
Countries around the world have sought to limit the dangers of Pradaxa bleeding injuries by requiring action on behalf of the manufacturer to warn of bleeding dangers. In August 2011, Japanese regulators told Boehringer Ingelheim to issue a warning for the drug after 81 of the almost 64,000 mainly elderly patients taking the drug there suffered excessive Pradaxa hemorrhaging. In May 2012, the European Medicines Agency acknowledged fatal bleedings with Pradaxa and encouraged clearer guidance for usage.
As always, I will keep my readers apprised of developments in this case. Click here for in-depth information on Pradaxa, including the FDA announcements and the serious risks being linked to the drug.
The Help You Deserve
If you or a loved one have taken Pradaxa and suffered internal bleeding / hemorrhaging, stroke, heart attack and/or other serious complications, please contact The Michael Brady Lynch Firm for a no-cost, confidential evaluation of your case. We will explain your legal rights and options. This way you can make the best decision for you and your family.