Internal Bleeding Treatment

All anticoagulants (blood thinners) carry the risk of internal bleeding. But there are usually countermeasures known as “reversal agents” – treatments to stop internal hemorrhaging and save a patient’s life. Except when it comes to Pradaxa internal bleeding. Because with Pradaxa, there’s no ready cure.

When Pradaxa was introduced to the U.S. market in October 2010, it was the first oral blood thinner approved by the FDA in 50 years. It’s only competitor was Coumadin (warfarin), a drug which had been used for half a century. Coumadin and Pradaxa are both prescribed as anticoagulant medications to reduce the risk of stroke and blood clots in patients with a heart rhythm disorder known as non-valvular atrial fibrillation. The major difference between the two is that Coumadin requires periodic blood tests and dietary restrictions, whereas Pradaxa requires no regular testing.

Initially, Pradaxa’s one-size-fits-all approach was appealing. It provided patients freedom from regular doctor visits, and a greater range of food choices. And manufacturer Boehringer Ingelheim spent $460 million in 2011 alone on advertising telling doctors and patients alike how easy and convenient Pradaxa was. But then patients started to experience Pradaxa hemorrhaging events, and doctors began to realize that there was no readily available internal bleeding treatment to counteract the effects of the drug.

During the first six months that Pradaxa was on the market, the FDA received more than 500 adverse event reports of Pradaxa internal bleeding and deaths. To put that in perspective, Pradaxa had received more complaints than 98% of all other drugs in the United States. Pradaxa hemorrhaging events are most commonly linked to gastrointestinal bleeds, rectal hemorrhages, and cerebrovascular accidents (brain hemorrhaging).

Typical internal bleeding treatment

When a patient suffers internal bleeding due to an accident or wound, doctors respond with emergency care: make sure the patient is breathing and apply pressure to any external wounds. Then, they can assess hemorrhaging and treat any injury, sometimes with surgery.

Treatment is different for bleeding not caused by physical trauma. For example, Coumadin (warfarin) reduces the risk of blood clots by moderating a patient’s vitamin K levels – less vitamin K equals a reduced risk of blood clots and, in turn, stroke. But Pradaxa works differently: the drug is a thrombin-inhibitor, meaning that it inhibits (blocks) thrombin, the enzyme responsible for blood clotting.

Though the two drugs share an end result – blood thinning, or anti-coagulation – the difference between them is key to developing an effective internal bleeding treatment. To counteract hemorrhaging events related to Coumadin, doctors can inject a patient with vitamin K. Raising these vitamin levels effectively reverses the effect of Coumadin and allows the blood to clot, stopping bleeding. But there is no easy, readily available method to un-inhibit the thrombin enzyme, so there is no simple cure for Pradaxa bleeding. This is why the FDA has received so many reports of life-threatening and fatal Pradaxa internal bleeding injuries.

Over time, protocols have been established to treat internal bleeding from Pradaxa. They are not as effective as reversal measures for other anti-coagulants, but they can help slow bleeding and save lives.

Treatment options include:

• Surgery
• Fluid replacement
• Hemodialysis
• Oral charcoal application
• Consideration of rFVlla or FFP

How to identify Pradaxa internal bleeding

Several symptoms can help you identify internal hemorrhaging.

If you are taking Pradaxa and experience any of these warning signs, seek immediate medical attention.

• Bleeding gums
• Bloody cough
• Dark red, black or tarry stools
• Dizziness or vertigo
• Frequent bloody nose
• Headaches
• Joint pain
• Lethargy or unexplained exhaustion
• Pink or brown urine
• Unusual bruising or bleeding
• Vomiting blood, or vomiting a substance that resembles coffee grounds
• Weakness and/or swelling in your extremities – arms, hands, lower legs, feet, and ankles

FDA weighs in on Pradaxa bleeding

In December 2011, just 14 months after Pradaxa hit U.S. shelves, the FDA had received adverse event reports for 500 Pradaxa-related deaths, 900 gastrointestinal hemorrhages, 300 rectal hemorrhages, and more than 200 brain hemorrhages. That month, the FDA issued a Pradaxa Safety Communication and informed U.S. consumers that the agency was evaluating post-marketing reports into the risk of Pradaxa internal bleeding.

Just a month later in January 2012, the FDA ordered Boehringer Ingelheim to update the drug’s warning label. Requested changes included a warning for patients with renal impairment (kidney problems), and to indicate that Pradaxa incurred an increased risk of bleeding. In November 2012, the FDA stated that Pradaxa bleeding events did not seem more common than those associated with Coumadin/warfarin. The federal agency did not address the lack of internal bleeding treatment for patients taking Pradaxa.

Pradaxa lawsuits filed

The first three lawsuits citing Pradaxa internal bleeding were filed in March 2012. That number climbed quickly, and by August 2012 at least 48 federal lawsuits were pending. In July 2012, the Judicial Panel on Multidistrict Litigation (JPML) consolidated federal cases into multidistrict litigation in the U.S. District Court for the Southern District of Illinois. Individual and MDL Pradaxa lawsuit plaintiffs seek damages for Pradaxa bleeding injuries, including the death of loved ones.