Pradaxa is the brand name of a generic drug called dabigatran and is manufactured by Boehringer Ingelheim. Pradaxa is an oral medication intended to stop the formation of blood clots and to reduce the chances of a stroke. It is a form of anticoagulant, a type of drug often called a “blood-thinner.”
Although Pradaxa was just approved by the FDA for sale in 2010, the drug has already been blamed for causing more than 500 deaths. The deaths occur when patients bleed uncontrollably as a result of the medication.
If you or a loved one has suffered uncontrollable bleeding or experienced other dangerous side effects of Pradaxa, you could be entitled to compensation for your losses. A Pradaxa injury attorney at Roberts & Roberts can help you determine if you have a case and how best to proceed with your claim.
According to the FDA Medication Guide, Pradaxa is a prescription drug administered to patients with atrial fibrillation (irregular heartbeat). An irregular heartbeat can cause blood clots, which can, in turn, increase the risk of a stroke if the blood clots cut off oxygen to the brain.
Pradaxa reduces the chance that clots will form,which reduces the risk of a stroke. Pradaxa works by inhibiting the normal action of a clotting protein called thrombin. The drug is taken in capsule form, normally twice per day, and is part of a class of medications known as direct thrombin inhibitors.
Pradaxa was the first significant advancement in blood-thinning medications in almost half a century. When the drug came on the market, it was offered as an alternative to warfarin, a blood-thinner known to increase the risk of dangerous bleeding and brain hemorrhages.
Boehringer Ingelheim spent around $464 million in 2011 to market Pradaxa as an alternative to warfarin. The marketing efforts worked; within just one year of coming onto the market, the drug was prescribed to 16 percent of patients with an irregular heartbeat.By 2012, more than $1 billion worth of Pradaxa had been sold and thousands of patients were taking the anticoagulant medication.
The Dangers of Pradaxa
Although Pradaxa was hailed as a safer alternative to other blood-thinners, it became very clear that Pradaxa has some serious dangers of its own. In 2012, a report from the Institute for Safe Medicine Practices named Pradaxa as one of the top 10 drugs reported to the FDA by patients complaining of adverse side effects or bad reactions.
According to the Institute for Safe Medicine Practices, a large number of complaints were made to the FDA about Pradaxa in 2011 alone.
- A total of 3,781 complaints were made about dangerous side effects of the drug.
- In 2,367 of the complaints, it was reported that a hemorrhage had resulted from Pradaxa.
- In 542 of the complaints, it was reported that death had resulted from Pradaxa.
- In 644 complaints, a stroke was linked to Pradaxa.
- In 291 of the complaints, it was reported that acute renal failure had developed as a result of Pradaxa.
- In 15 cases, the complaint indicated that Pradaxa had potentially contributed to liver failure.
The FDA indicated in a 2012 report that the risk of bleeding with Pradaxa was not higher than the risk of bleeding in patients taking warfarin. However, warfarin works differently from Pradaxa. Warfarin works by reducing the effectiveness of vitamin K, which is necessary for the formation of blood clots. When a hemorrhage occurs in a patient on warfarin, a dose of vitamin K is an antidote. No such option exists for patients hemorrhaging due to Pradaxa, and there is no easy effective way to stop the bleeding.
Pradaxa Side Effects
When patients experience problems as a result of Pradaxa, they may exhibit a number of symptoms and face many potential risks.
- The FDA indicates that patients on Pradaxa may experience unusual bruising or bleeding; vomiting or coughing up blood; tarry or discolored urine or stools; uncontrolled bleeding from the gums or nose; problems clotting if cut; heavy menstrual bleeding; swelling or pain in the joints; fatigue or weakness; a feeling of being dizzy or lightheaded; hives; rashes; and swelling.
- Cleveland Clinic Researchers found that Pradaxa increases the risk of heart attack or severe heart disease symptoms by 33 percent when compared with patients taking warfarin. A study from the American College of Cardiology also found an increased risk of heart attack after reviewing trials of more than 30,470 patients.
The FDA issued a MedWatch communication on the risk of serious bleeding in November 2012. In other countries, government regulatory agencies have taken strong action, with both Japan and Australia issuing safety warnings related to the risks presented by Pradaxa.
Taking Legal Action for Pradaxa Injuries
There are currently more than 250 lawsuits pending against Boehringer Ingelheim by patients or family members of patients who suffered complications as a result of Pradaxa. The lawsuits against Pradaxa have been consolidated into multi-district litigation so certain questions of fact can be resolved in a way that will apply to multiple cases. If you or a loved one has been injured by Pradaxa, you may wish to join the multi-district litigation or you may wish to bring your own lawsuit.
An experienced Pradaxa injury attorney at Roberts & Roberts can help you to understand your legal rights and can work on your behalf to obtain the compensation you deserve if you were hurt as a result of taking Pradaxa. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.
- Institute for Safe Medication Practices– “Why Reports of Serious Adverse Drug Events Continue to Grow”
- FDA– Pradaxa Medication Guide
- CBS News– “Study: Higher heart attack risk from Pradaxa”
- Reuters– “Pradaxa And Xarelto: Top Heart Doctors Concerned Over New Blood Thinners”
- FDA– “Pradaxa (dabigatranetexilatemesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events”