The U.S. Food and Drug Administration evaluated reports of internal bleeding incidences in patients who were prescribed and took Pradaxa, a blood thinning, or anticoagulant, medication.

According to the FDA, Pradaxa is an anticoagulant that is prescribed to reduce the risk of stroke and blood clots, known as systemic embolism, in patients with non-valvular atrial fibrillation, a type of irregular heart rhythm Atrial fibrillation is the most common type of heart rhythm abnormality.

According to the FDA, internal bleeding from Pradaxa is a well-recognized complication that can lead to serious and fatal outcomes, as it is with all anticoagulant medications. The FDA states that the anticoagulant’s drug label contains warning of serious internal bleeding from Pradaxa that may result.

According to the FDA, “in a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.”

Symptoms of internal bleeding from Pradaxa, according to the FDA, include: frequent occurrences of nose bleeds, pink or brown urine, uncontrolled severe bleeding, usual bleeding from the gums, red or black stools, bruises that happen without known cause, and the vomiting of blood or vomit that looks like coffee grounds.

History of Pradaxa

Pradaxa was first introduced on the market in October 2010. With its arrival, it quickly became one of the most widely prescribed blood thinners worldwide. However, within six months of its approval by the FDA , the agency received 500 reports of internal bleeding from Pradaxa incidents, which includes death and injury among its patients.

In December 2011, after receiving 3,781 reports of Pradaxa side effects and 542 deaths among patients who had taken Pradaxa, the FDA announced that it would review the safety of Pradaxa. The reports that the FDA received were reports of internal bleeding from Pradaxa. These reports included heart attacks, and internal bleeding in the intestines, kidneys, and brain.

The Journal for the American Medical Association had warned in September 2012 that the FDA may have prematurely approved Pradaxa and that severe adverse side effects were overlooked. And in March 2012, an article in the Journal of Neurosurgery described the internal bleeding event a patient suffered from having taken Pradaxa. According to the details of the specific case, “once Pradaxa causes internal bleeding, there is very little they can do to stop it.”

An additional study by the University of Pecs in Hungary further stated that the drug’s risk outweighed its benefits. Researchers reported that patients taking Pradaxa were several times more likely to suffer an internal bleeding episode after suffering from an acute heart condition.