Doctors from Harvard Medical School and Brigham and Women’s Hospital released a new study last week further questioning the safety of blood thinning drugs like Pradaxa, based on the risks of internal bleeding.
The study comes as the maker of the drug, German pharmaceutical giant Boehringer Ingelheim, prepares to defend thousands more lawsuits from injured patients and their families after paying out an initial $650 million settlement in 2014.
Harvard Study Highlights Pradaxa Bleeding Risks
The results were released in notable publications British Medical Journal on May 24th and Journal of the American Pharmacists Association on May 26.
Led by Dr. Shirley Wang, an epidemiologist at the facility, the team of six researchers followed data from nearly 22,000 patients who were taking either Pradaxa or warfarin for atrial fibrillation between 2009 and 2013.
Of these, approximately 6,500 were taking Pradaxa and 15,500 were taking warfarin. The researchers found that the rate of blood clot injuries were largely consistent with that indicated in clinical trials used for FDA approval. However, they also discovered that the rate of major internal bleeding injuries were significantly underestimated by these clinical trials.
Pradaxa Internal Bleeding Underreported in FDA Trials
Overall, the data showed an alarming 4.6% of patients experienced major internal bleeding for each year the blood thinners were used. The doctors found this rate was around 66% higher than what was indicated to the FDA in clinical trials.
Pradaxa, released in 2010, has been marketed along with Xarelto as a safer alternative to the traditional blood thinner warfarin. However, the manufacturer failed to inform patients for years that Pradaxa didn’t have an antidote to stop bleeding in emergencies, as warfarin did.
FDA records show more than 10,000 patients have suffered severe gastrointestinal bleeding while taking the drug, requiring hospitalization. Worse, more than 1,000 patients have died from internal bleeding.
New Pradaxa Lawsuits Filed After 2014 Settlement
In 2014, after a federal court found Boehringer Ingelheim had concealed Pradaxa safety data from the public, the company paid $650 million to settle the first phase of over 4,000 internal bleeding lawsuits.
Since then, thousands more have filed suit after suffering similar injuries or the loss of a loved one.
Currently, lawyers from several top law firms are helping Pradaxa victims in all 50 states file lawsuits against the manufacturer, and they expect the company will face trials in the coming year unless they agree to another settlement.
For more information on the bleeding risks of Pradaxa, or to speak directly with a lawyer about a lawsuit, contact DrugNews today.
Wang, S. et al. Prediction of rates of thromboembolic and major bleeding outcomes with dabigatran or warfarin among patients with atrial fibrillation: new initiator cohort study. BMJ. (May 24, 2016). Retrieved from www.bmj.com
American Pharmacists Association. Prediction of thromboembolic and major bleeding outcome rates with dabigatran or warfarin for AF. (May 26, 2016). Retrieved from www.pharmacist.com
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