Is the FDA Endorsing Risky Blood Thinner Medications?

This past week, the United States Food and Drug Administration (FDA) concluded a year long study into Pradaxa (dabigatran etexilate) and determined it was no more dangerous than its competitor, Warfarin. In a letter to the public, the FDA recognized a number of popular blood thinners as having beneficial effects to help patients ward off strokes. This included Warfarin, Pradaxa, and Xarelto.

None of these drugs are perfect, and no medication can realistically claim to be, but the amount of reported deaths and severebleeding events reported by Pradaxa users is a cause for serious concern. With similar characteristics and similar trial results, Xarelto has become a concern for some industry watch dogs.

What is Xarelto

Xarelto (Rivaroxaban) is a blood thinner medication prescribed to patients with atrial fibrillation, the most common form of cardiac arrhythmia. This condition affects an estimated 3 million Americans and 15% of elderly Americans over the age of 80. In these patients, there is significant increased risk for developing a blood clot in the heart due to blood pooling in a storage chamber of the heart, which can travel to the brain, causing a stroke.

Xarelto acts by inhibiting the Factor Xa protein.  The Factor Xa protein is generated by both the extrinsic and intrinsic coagulation pathways and it activates prothrombin to thrombin, which activates the final components of the coagulation pathway to form clots. Factor Xa inhibitors are generally used as prophylaxis in patients having hip and knee replacement surgery, where blood clots can form and lead to deep vein thrombosis and pulmonary embolism.

Traditionally, blood thinners worked by inhibiting vitamin K production in the blood to prevent blood clots.  Xarelto works differently by inhibiting the Xa protein in the blood and therefore does not have a reversal agent like its competitors (i.e. Warfarin) which inhibit vitamin K production in the blood.

What Were the Observed Complications that Caused Researchers Concern

In the drug trials, researchers named a number of severe complications which could be caused by Xarelto.  Similar to Pradaxa’s observed side effects and complications, Xarelto is equally concerning considering its lack of a reversal agent.  In the first quarter alone, Xarelto had 356 reported adverse health complications.  Among these reported adverse health complications were the following:

·         Fatal bleeding event

·         Brain hemorrhage

·         Liver abnormalities

·         Kidney abnormalities

·         Collection of clotted blood in the organs or tissue

·         Jaundice/ yellowing of skin due to liver problems

·         Spinal epidural hematoma

·         Bleeding in the abdomen

·         Hemorrhage within the skull

·         Blockage of normal bile flow

·         Stevens- Johnson Syndrome (a skin disorder due to allergic reaction or infection which can be characterized by herpes, skin lesions, sores, vision problems)

·         Life threatening allergic reaction

·         Severely decreased blood platelets

·         Deficiency of Granulocytes (white blood cells)

If You Have Been Injured By Your Blood Thinner Medication

Unfortunately, because Xarelto and Pradaxa both lack reversal agents, these severe complications could turn deadly with little to no recourse for doctors treating these patients.  In comparison, Warfarin’s side effects can be treated with a vitamin K shot to clot the blood.  Patients and their families who have suffered Xarelto blood thinner injuries are encouraged to seek a talented product liability attorney to determine their eligibility for compensation. 

Do I Have a Pradaxa Case

To patients suffering with atrial fibrillation, blood thinner medication can be life saving.  By stopping potentially fatal blood clots from forming, patients are able to avoid strokes and heart attacks.  However, the latest blood thinner medication to come under scrutiny has been Pradaxa. 

Sold as a new and improved version of Warfarin, Pradaxa was supposed to thin the blood and require less doctor oversight.  Instead of blocking Vitamin K production like Warfarin and similar drugs, Pradaxa worked by inhibiting thrombin, the clotting agent in the blood. Unfortunately, because of this significant difference, if patients experienced fatal bleeds, they could not clot the blood with a shot of Vitamin K.  In fact, Pradaxa had no reversal or clotting agent to offer patients.

If You Have Been Injured By Pradaxa

Pradaxa patients could face serious and lasting injuries as a result of taking their medication as prescribed.  This could include:

·         Potentially fatal bleed outs

·         Increased risk of heart attacks

·         Increased bleeding in the kidneys

·         Bleeding in the brain

·         Purple spots under the skin, abnormal bleeding from the gums, mouth, vagina, and rectum

·         Blood in your urine or stools

·         Coughing up blood or vomit

·         Intestinal bleeding, ulcers

·         Death

How Strong Is Your Pradaxa Case

If you've suffered adverse reactions to Pradaxa, your product liability attorney will want to know whether these began before or after January, 2012, when the FDA mandated changed warning labels. Incidents occuring prior to January 2012 are likely to lead to a stronger case than those experienced after the FDA mandated changed labels.

Patients who suffered the following will have stronger cases:

·  gastrointestinal bleeds

·   a hemorrhagic stroke


· trauma-induced atypical bleeding event

· death


It is important that you seek medical help for any Pradaxa injuries first.  And when you're well, seek the skilled advice of a product liability attorney.