Pradaxa is a blood thinning drug that has been successful in treating stroke risks in patients with atrial fibrillation. However, blood thinner side effects with Pradaxa have adversely affected hundreds of patients.

Pradaxa, generically known as dabigatran, is a direct thrombin inhibitor. This means that this drug attaches itself to a blood clotting agent called thrombin. Pradaxa reduces the ability of the blood to form clots.

If the blood in the body cannot form clots as easily as before, conditions such as stroke and deep vein thrombosis are less likely to occur. Atrial fibrillation is a dangerous condition in which the blood of the heart does not pump normally. Blood pools in one of the heart’s chambers and is at risk of clotting.

Pradaxa, and other similar blood thinners, help to keep that blood from clotting, which could lead to life threatening conditions.

Pradaxa was approved by the U.S. Food and Drug Administration in 2010 and then was marketed by drug manufacturer Boehringer Ingelheim as a drug that was superior to the market standard, Coumadin.

Coumadin, generically known as warfarin, was the drug that was used most popularly to treat similar conditions. However, when Pradaxa and other direct thrombin inhibitors were approved, the drug manufacturer promoted Pradaxa as superior to warfarin because it did not require the same level of monitoring or diet changes like warfarin did.

However, the blood thinner side effects associated with Pradaxa may be more dangerous than those associated with warfarin. If a patient taking warfarin became injured or suffered internal bleeding, the attending physicians would need to administer vitamin K as a way to stop the bleeding.

But for many years after Pradaxa patients entered the market, Pradaxa patients did not have such an option. Blood thinner side effects of Pradaxa have included excessive bleeding for patients because there was not a Pradaxa reversal agent until just recently. Before then, Pradaxa patients who suffered an emergency situation or became injured did not have an antidote available to them.

Many Pradaxa patients suffered excessive blood thinner side effects such as dangerous bleeding. In fact, in just the first three months that Pradaxa was on the market, there were 307 reports received by the FDA reporting gastrointestinal bleeding, excessive internal bleeding and other serious blood thinner side effects.

The FDA received reports of 260 deaths in the first year of approval. These reported deaths resulted from internal bleeding, gastrointestinal bleeding, hemorrhage and stroke. By the end of the year 2012, Pradaxa was associated with more than 500 fatalities.

It wasn’t until recently that a Pradaxa antidote was approved to treat blood thinner side effects such as excessive internal bleeding. In October 2015, a Pradaxa reversal agent, Praxbind, was approved by the FDA. This allowed those with extreme Pradaxa side effects such as dangerous internal bleeding to have access to an antidote.

But for many patients, this reversal agent came too late. Praxbind wasn’t approved until five years after Pradaxa had been on the market and after countless patients had been affected by blood thinner side effects from Pradaxa.