May is Stroke Awareness Month: Pradaxa and Other Blood Thinner Risks Assessed

The Centers for Disease Control and Prevention (CDC) announced that May is Stroke Awareness Month.  According to the CDC, someone has a stroke in the U.S. every 40 seconds.  In 2008, one person every four minutes died of a stroke, making it the fourth leading cause of death in the U.S. 

Strokes occur when blood flow to the brain is blocked, or when a blood vessel in or near the brain bursts.  Though most often associated with older Americans, strokes can happen to people of any age. 

Aside from death, strokes can lead to several serious complications.  These include the following:

  • Paralysis
  • Weakness on one side of the body
  • Difficulty understanding speech or speaking
  • Problems with thinking, awareness, attention, learning, memory, and judgment 
  • Problems expressing or controlling emotions
  • Numbness
  • Hand and foot pain
  • Depression

Although the CDC notes many factors play a part in a patient’s risk of stroke, such as age, sex, ethnicity, and family history, there are steps that can be taken to minimize those risks.  These include avoiding smoking and secondhand smoke, having an appropriate aspirin therapy, keeping blood pressure under control, managing cholesterol, exercising, eating healthy, limiting alcohol consumption, preventing or controlling diabetes, and maintaining a healthy weight. 

One new medication which has been approved for patients at risk of having a stroke is Pradaxa (dabigatran etexilate mesylate).  A blood thinner, or anticoagulant, Pradaxa is used in patients with non-valvular atrial fibrillation (AF) at risk for developing blood clots that can cause stroke. 

However, this medication is not without its side effects.  Because it reduces the risk of blood clot formation, the oral antithrombotic therapy also presents patients with an increased risk of fatal bleeding.  The U.S. Food and Drug Administration (FDA) is currently working with Pradaxa’s manufacturer to determine if the reports of bleeding associated with this medication are higher than should be expected.   

A Bloomberg article from earlier this year also points out that Pradaxa has been identified in several clinical trials as increasing the risk of heart attacks and acute coronary syndrome (ACS).  According to the news source, 237 out of 20,000 patients taking Pradaxa had a heart attack or chest pain.  This is in comparison to 83 out of 10,514 patients who took a placebo or the standard drug warfarin.  

In response to these concerns about Pradaxa, the drug’s manufacturer, Boehringer Ingelheim, recently announced the launch of the GLORIA(TM) -AF Registry Program.  According to the manufacturer’s press release, this program “is set to become the largest worldwide registry with the aim of understanding the long-term use of oral antithrombotic therapy in the prevention of non-valvular atrial fibrillation (AF)-related stroke in a real-world setting.”    

The press release explains that 56,000 patients across 2,200 sites in 50 countries are planned for enrollment.  The manufacturer's announcement said it will provide more details regarding the “unique study design” of this registry program later this year.       

Patients currently taking Pradaxa are encouraged to discuss any and all concerns about this medication with their doctor and seek immediate medical care if any of the following symptoms of bleeding are developed:

  •   Strange bleeding from the gums
  •   Frequent Nose bleeds 
  •   Heavier than normal menstrual or vaginal bleeding 
  •   Severe, uncontrollable bleeding 
  •   Pink or brown urine
  •   Red or black stool
  •   Unexplained bruises that enlarge
  •   Coughing up blood or blood clots
  •   Vomiting blood or vomit that looks like coffee grounds