Pradaxa, a blood thinning medication, has been linked to over 260 deaths and more adverse events than 98.7% of all other drugs monitored by the FDA.
Pradaxa use has been shown to significantly increase risk of potentially fatal side effects, including:
- Uncontrollable Internal Bleeding (hemorrhaging) of the
- Gastrointestinal (GI)
- Heart Attack/ Cardiac Injury
Death may be caused by heart attacks but is most often linked to fatal bleeding issues such as:
- A traffic accident or bodily trauma after which bleeding cannot be stopped
- Uncontrollable bleeding in connection with medical conditions such as ulcers
- Inability to receive life-saving emergency surgery due to excessive bleeding risks
- Spontaneous brain, GI or kidney bleeding
What is Pradaxa?
Pradaxa (generic: dabigatran) is an anti-coagulant, or blood thinner, that is prescribed to prevent blood clots and reduce the risk of strokes in patients with non-valvular atrial fibrillation. As with many prescriptions, it is also used for off-label purposes.
Manufactured by Boehringer Ingelheim GmbH and approved in October 2010, Pradaxa was the first drug to compete with Warfarin for the blood thinner market. Pradaxa critics believe Boehringer did not thoroughly research the side effects of Pradaxa while rushing it to market to beat the impending competition of Bayer’s Xarelto and Pfizer’s Eliquis. Boehringer had a duty to research and report all dangers associated with Pradaxa use; this responsibility was especially crucial due to the expected popularity of Pradaxa, as the first alternative to Warfarin. Indeed, 1.1 million Pradaxa prescriptions were dispensed between 2010 and 2011, thus putting 1.1 million people at risk for injury or death.
Pradaxa Has No Antidote
Pradaxa produces anticoagulation (blood thinning) through direct inhibition of thrombin. Pradaxa, unlike Warfarin, does not have a reversal agent or antidote that can be administered should a bleed occur. As a result, if a Pradaxa related bleed occurs, the patient is at a high risk for death. Warfarin, on the other hand, works by inhibiting vitamin K-dependent coagulation factors. Should a major bleed occur with Warfarin use, oral or parenteral vitamin K1 can be given which reverses the anticoagulation effects. As a result, while Warfarin also involves a risk of bleeding, the treatment if a bleed does occur is very effective. There is no such solution to Pradaxa bleeding events.
Pradaxa Injuries and Deaths Reported to FDA
Within a month of approval by the Food and Drug Administration (FDA), Pradaxa was linked to more adverse events than 98% of other drugs monitored by MedWatch, the FDA’s reporting system.
In the first quarter of 2011 – mere months after Pradaxa was introduced – the FDA received reports of 120 deaths linked to Pradaxa use. Additionally, there were 505 reports of hemorrhage, or uncontrollable bleeding, during this period, which is triple the number associated with Warfarin.
In August 2011, Boehringer spokesman Reinhard Malin stated that 50 deaths worldwide was “probably in the right range.” By November, the European Medicines Agency (EMA) reported more than five times the expected number of deaths among Pradaxa users. The EMA mandated a change to Pradaxa’s safety label.
Research Against Pradaxa
In January 2012, a study published in the Archives of Internal Medicine found that Pradaxa use leads to a 33 percent increased risk of heart attack. Conducted by researchers at the Cleveland Clinic, the study evaluated data of more than 30,000 patients, comparing Pradaxa to Warfarin-based drugs. Also, in a recent article published in the American Journal of Hematology, the authors discuss the lack of an antidote for Pradaxa related bleeds and describe alternative treatments.
Find Out More About Your Legal Rights
If you or a loved one suffered injury or death as a result of Pradaxa use, contact Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests. You can reach us by calling toll-free at 1-877-446-9001 or by following the link to our free case evaluation form located on this page.