Our law firm is now reviewing potential Pradaxa lawsuits. If you believe you may have a potential Pradaxa lawsuit, call 800-553-8082 or get a free on-line Pradaxa claim consultation here.
Overview of Pradaxa
Pradaxa is a blood thinner, which is a product used to prevent the formation of blood clots in people with atrial fibrillation (irregular heart beat). This is important for prevention of strokes and heart attacks. It was intended to replace Warfarin (Coumadin), and drug-makers were hopeful that it would require less monitoring. The generic name of the drug is dabigatran.
Part of the allure of Pradaxa is that, unlike Warfarin, it requires no dietary restrictions, and no blood tests. No doubt, this is a huge deal to patients who can better fit their clotting medication in with their lives. However, cost analysis suggests that the drug, though more convenient, may have a higher total overall medical cost than Warrfarin, a cheaper drug that has been on the market since the 1950’s.
Who Makes Pradaxa?
Pradaxa, released to the market in October 2010, is manufactured by German company Boehringer Ingelheim.
What Is the Injury in Pradaxa Lawsuits?
In early 2011, the FDA received over 500 reports of Pradaxa bleeding injuries—this within months of the drug’s release. Users of Pradaxa may suffer from internal bleeding, hemorrhaging, or other problems. By December of 2011, the FDA announced a Pradaxa safety review, the first step toward determining whether a Pradaxa recall is necessary.
The National Institutes of Health reports 932 serious events between January 2011 and March 2011:
- 120 deaths
- 25 permanent disabilities because of the drug
- 543 hospitalizations
- 505 incidents of hemorrhage or internal bleeding
Warfarin, the drug that Pradaxa was intended to replace, may also cause internal bleeding. However, those problems can be countered by administering vitamin K (because Warfarin interferes with vitamin K, which is essential to creating blood clots). For Pradaxa patients, there is no similarly simple solution for excessive internal bleeding.
Additionally, researchers are investigating whether the drug is effective. The FDA is concerned that the drug may have too little effect, which may cause deep vein thrombosis and pulmonary embolism.
What Did Pradaxa's Manufacturer Do Wrong?
Though the investigation is continuing, there may have been over 500 Pradaxa-related deaths in the first year of use. Experts are concerned that the initial clinical trials were faulty, which may have allowed this defective drug to be rushed to the market. Boehringer Ingelheim conducted a study called the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, and gave that information to the FDA to prove that it was ripe for release to the market.
Warfarin and its generic version, Coumadin, are manufactured by Bristol-Myers Squibb. That company sold over 2.6 million prescriptions in 2006, and had little competition. That’s a huge financial incentive for other companies, like Boehringer Ingelheim, to get a piece of the action. From the time Pradaxa was approved to August 2011, Boehringer Ingelheim sold over 1.1 million prescriptions.
What is the Status of the Pradaxa Lawsuits?
There is no Pradaxa class action or MDL yet although our attorneys suspect it is just a matter of time. Right now, lawyers and their expert doctors are evaluating the claims of Pradaxa patients. These lawsuits will be filed on an individual basis, though plaintiffs’ attorneys will likely seek to combine them (for discovery purposes) later in an MDL.
Do I Have a Potential Pradaxa Claim?
If you are still taking Pradaxa, be sure to talk to your doctor about the risks and benefits of taking the drug. Save all pharmacy receipts, prescription bottles and free sample packages given to you by your doctor. These could be important evidence in your case.
If you believe you have a Pradaxa claim, it is important for you to contact the FDA through MedWatch to report the problems you have had with the drug. These reports will help the FDA to determine whether a Pradaxa recall is necessary. Contact our Pradaxa attorneys at 1-800-553-8082, or get a free evaluation of your potential Pradaxa injury or wrongful death claim.
More Information on the Problems with Pradaxa
- Latest Pradaxa Update: December 26, 2012
- Institute for Safe Medication Practices (Pradaxa has more adverse reports than 98.7% of all other monitored drugs)
- Bloomberg Report: Pradaxa users have a significantly higher risk of heart attacks, compared with Warfarin users
- Comparing Pradaxa and Coumadin: newer may not always mean better
- Pradaxa Medication Guide (2011)
- FDA Drug Safety Communication (Dec. 7, 2011)
- RE-LY trial results, published in the New England Journal of Medicine (September 17, 2009)
- Drug Recall Lawyer Blog (Dec. 7, 2011): FDA Evaluates Pradaxa For Reports of Serious Bleeding Events