Before taking a blood thinner, you should know about Pradaxa uncontrollable bleeding side effects.

The FDA approved Pradaxa for use as an anticoagulant in October 2010.

More commonly known as a blood thinner, the medicine reduces the chances of a stroke by reducing blood clotting mechanisms.

Pradaxa Uncontrollable Bleeding Side Effects Can Result in Death

Even though Pradaxa has prevented blood clots from forming, it has also led to Pradaxa uncontrollable bleeding side effects.

After just about one month on the market, 260 patients fatally bled out after taking Pradaxa. An additional 540 patients died in 2011 after taking it.

The FDA says that Pradaxa uncontrollable bleeding side effects is one of the top drug-related adverse events it receives in overall reports.

In 2012, Pradaxa maker Boehringer Ingelheim finally warned that Pradaxa-induced bleeding was irreversible and that there was no reversal antidote available at that time.

However, the company allegedly had developed an antidote even before Pradaxa was approved to be sold in the United States.

Boehringer Ingelheim didn’t seek approval of Praxbind, the antidote/reversal agent, until February 2015. Praxbind finally was introduced in the fall of 2015, but it was too late for many patients.

Institute for Safe Medication Practices Warns of Pradaxa’s Dosing Issues

Dr. Curt Furberg is a medical advisor to the Institute for Safe Medication Practices (ISMP), a nonprofit organization dedicated to educating the healthcare community and the public about medication safety.

Dr. Furberg says that Pradaxa has a wide variety of clot-preventing effects, depending upon the patient.

Pradaxa comes as only a single-dose medication in the United States, but it approved in two different dosages in Europe.

Even though Pradaxa is marketed as a one-dose-fits-all medication, Dr. Furberg says that Pradaxa might effectively prevent strokes in some patients, but the dose is too low to be effective in other patients.

In yet other patients, the dose can be too high, which means an increased risk of Pradaxa uncontrollable bleeding side effects for those people.

“If you’re a patient on Pradaxa or Xarelto, I think you should talk to your physician and ask whether the drug should be switched to a safer and more effective oral [anticoagulant],” Dr. Furberg says.

Pradaxa Uncontrollable Bleeding Side Effects Include Brain, Gastrointestinal Hemorrhaging

Pradaxa uncontrollable bleeding side effects can include intracerebral hemorrhage (brain bleeding) and hematoma expansion.

When a blood vessel wall or vein is damaged, it can leak blood into surrounding tissues, creating a hematoma, which can be small or can be large enough to cause swelling and pain.

Hematomas in the brain are the most dangerous because the skull is enclosed and cannot expand like skin can. When a hematoma develops in the brain, it increases pressure and impairs brain function.

In 2011, a study using mice confirmed the connection between Pradaxa and hematoma expansion. Stroke online magazine by the American Heart Association provided details of what happened when mice received Pradaxa.

Researchers observed intracerebral hematoma expansion during the first three hours. A higher dose of Pradaxa increased the hematoma volume substantially within that three-hour period.

Pradaxa works by blocking thrombin, a clotting protein. When this clotting protein is not working optimally, side effects include bruising, minor bleeding, indigestion and heartburn.

When too much of the clotting protein is halted from doing its job, gastrointestinal bleeding can be the result.