Every medication carries risks for certain side effects, some more severe than others.

Patients taking blood thinner medication should be fully aware of Pradaxa internal bleeding symptoms associated with the drug, as they can be life threatening.

What is Pradaxa?

Dabigatran, sold as Pradaxa, is a blood thinning (anticoagulant) medication. It is prescribed for patients who are at risk of stroke and have nonvalvular atrial fibrillation. This is a heart rhythm abnormality that is caused by something other than abnormal atrial heart valves. Of all types of heart rhythm abnormalities, atrial fibrillation is the most common.

As an anticoagulant, Pradaxa is meant to replace the use of warfarin, an anticoagulant with decades of use “under its belt.” Pradaxa is claimed to be an improvement over warfarin because it allegedly requires less monitoring by the treating physician.

From October 2010 (the time it was approved for use as an anticoagulant) through August 2011, a total of 1.1. million prescriptions of Pradaxa were filled and about 371,000 prescriptions were given to patients from U.S. outpatient retail pharmacies.

Pradaxa Internal Bleeding Symptoms

Internal bleeding symptoms vary depending on where in the body the bleeding is taking place, and how much blood is beign lost.

Patients taking Pradaxa who have any of the following symptoms may be suffering from internal bleeding and should contact their doctor immediately:

• Vomit containing blood
• Vomit that has the appearance of coffee grounds
• Bleeding gums
• Nose bleeds
• Red or black stools
• Coughs that produce blood or clors
• Menstrual bleeding that is heavier than usual
• Urine that is tinted pink or brown
• More bruises than usual, or bruises that get larger

Pradaxa Linked to Internal Bleeding

In December 2011, the U.S. FDA issued a safety announcement about Pradaxa to healthcare professionals and their patients. The FDA indicated that it was currently evaluating the reports it received from patients that indicated Pradaxa internal bleeding symptoms were a problem. These reports at issue were all filed after the release of Pradaxa onto the market.

The safety announcement also stated that the FDA believes the drug offers substantial health benefits to its users when it is used as directed. The communication encouraged physicians to carefully follow the dosing instructions and relevant information that appear on the Pradaxa product label.

The FDA safety communication went on to explain that Pradaxa internal bleeding symptoms that can cause serious damage or even death are “a well-recognized complication of all anticoagulant therapies.” The FDA stated it is continuing to evaluate if patients are experiencing Pradaxa internal bleeding symptoms at a higher rate than is to be anticipated.

As it stands, the Pradaxa label instructs physicians to test the kidney function of their patients before prescribing the medication and to maintain annual testing of patients who are 75 years or older. Additionally, for patients undergoing surgical procedures or otherwise invasive procedures, the medication should be discontinued beforehand and then restarted after the procedure.

The FDA safety release explained that bleeding that might cause serious and even fatal results is “a well-recognized complication of all anticoagulant therapies.” It said it is working to determine if bleeding is occurring in patients taking Pradaxa more often than would be expected.

Contact a Pradaxa Attorney

If you or someone you love has suffered because of Pradaxa internal bleeding symptoms, an attorney may be able to help you seek compensation. To learn more, schedule a free case review with a qualified Pradaxa lawyer today.