FDA’s Pradaxa Safety Conclusion Questioned

Despite being hailed as a better alternative to warfarin, Pradaxa users have experienced serious side effects such as uncontrollable intestinal bleeding, kidney bleeding, brain hemorrhage, gastrointestinal bleeding, internal bleeding, heart attacks and death. If you have suffered one of these serious Pradaxa side effects, you may qualify to join a Pradaxa class action lawsuit.

Pradaxa Poses Significant Bleeding Risks

In 2011, the FDA received reports of more than 500 deaths and nearly 4,000 Pradaxa side effects. That year, Pradaxa was linked to more deaths than any other drug. More than 150 Pradaxa lawsuits have been filed against Boehringer, accusing the company of knowing the serious bleeding risks posed by the drug. The federal lawsuits have been consolidated in a U.S. District Court in East St. Louis, Illinois.

In December 2012, the U.S. Food & Drug Administration (FDA) warned medical professionals that Pradaxa should not be used to prevent blood clots or stroke in patients who have mechanical heart valves. In patients with mechanical heart valves, the use of Pradaxa increases the risk of blood clots, heart attacks and stroke.

When the bleeding risks became known worldwide, concern grew that there was no effective way to reverse the anticoagulation effects. A recent study from the Cleveland Clinic found that patients who use Pradaxa may experience an increased risk of heart attack and irreversible bleeding complications. Unlike warfarin, there are no available antidotes available to reduce internal bleeding, a serious Pradaxa side effect.

FDA Research Methods Subject to Criticism

The FDA recently released a report that showed Pradaxa bleeding risks to be comparable to warfarin. However, the FDA’s research methods have been criticized. The FDA relied on data from insurance claims to reach their conclusion. While the FDA warns of the Pradaxa bleeding risk, the agency does not mention that there is no antidote. This information is important for doctors and patients to understand when they are making important health care decisions.

The Pradaxa bleeding risks are difficult to control and can cause significant damage to patients. The previous drug, warfarin, has an antidote that can reduce the drug’s bleeding risk, making warfarin a generally safer treatment following a stroke.

If you have suffered a Pradaxa injury, you may be able join a class action lawsuit. Visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation to see if you qualify. A Pradaxa lawyer will review your claim at no cost to you and let you know if you qualify to take legal action against Boehringer. If the class action lawsuit is successful, you may receive financial compensation for your Pradaxa injuries.