Tuesday, 20 of November of 2018

FDA Publishes Study Regarding Pradaxa’s Risk of Bleeding

By Randy Appleton, Virginia Medical Malpractice Lawyer

What Happened:

According to the Food and Drug Administration, the risk of serious bleeding among new users of Pradaxa appears to be no higher than in patients on other widely used blood thinners. The announcement by the FDA concerned the controversial blood-clot preventer made by Boehringer Ingelheim and said that Pradaxa’s risk of bleeding is in line with the more commonly prescribed drug, warfarin.

The news was meant to reduce worries among the many patients, including those in Virginia, who have used the drug, however the results were not based on any new clinical study. Instead, the FDA said they based their assessment on insurance claims and other data about patient healthcare outcomes.

The regulatory agency said over a year ago that it would launch an investigation into reports of serious bleeding among patients who had been prescribed Pradaxa. The drug was originally meant to prevent strokes in patients with an irregular heartbeat, a condition known as atrial fibrillation. Reports surfaced describing instances of gastrointestinal bleeding and uncontrolled bleeding in the brain, some of which resulted in death, which prompted a new look at the drug.

The FDA has said that while the information they reviewed indicates that there is a bleeding risk associated with Pradaxa, it is similar to the risk posed by warfarin. This does not mean the end of the investigation into the drug. On the contrary, the FDA announced it was planning to assess Pradaxa’s bleeding risks by other means and would report back on its findings.

Despite this seemingly good news about Pradaxa, another recent announcement highlights the lingering concerns about the blood thinner. A report issued by the Institute for Safe Medicine Practices’ QuarterWatch reveals that prescription drug complaints to the FDA have risen 90% in the past four years, and two drugs, Pradaxa and Chantix (a smoking cessation drug), are responsible for 37% of that increase.

The Virginia Injury Lawyer’s Perspective:

Since the news of the negative affects of the drug came to light, Pradaxa has been in the spotlight as thousands of lawsuits have been filed against the drug’s manufacturer, Boehringer Ingelheim. Sickened Virginia patients have alleged that the drug led to serious and even fatal bleeding, a problem that they say they were never properly warned about.

Given the recent studies showing the downsides of Pradaxa, it’s a wonder that the drug is still being marketed to patients. If you or a loved one has been seriously injured by a dangerous or defective drug, you should contact an experienced VA personal injury lawyer as soon as possible. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries. 

Helpful Info:

If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.

Have Questions? 

We maintain a library of attorneys’ answers to frequently asked questions regarding defective or dangerous drugs.


About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.