A stroke occurs every 40 seconds in the U.S. and stroke is the third leading cause of death, according to the American Stroke Association.
During a stroke, the blood flow to the brain is blocked. The interruption can cause paralysis, difficulty speaking, thinking, numbness, depression, or death.
Anticoagulants are prescribed to reduce the risk that a patient will suffer from blood clots or a stroke. For more than 50 years, Coumadin (warfarin) has been the standard drug that decreased the function of the clotting factors in the blood that cause stroke. But in October 2010, Pradaxa – dabigatran etexilate mesylate – was added to the stroke prevention drugs roster for patients with non-valvular atrial fibrillation (AF), an irregular heartbeat that puts patients at risk for developing a blood clot that can cause stroke.
A March study published by the Archives of Internal Medicine warned that Pradaxa use may increase the risk of fatal bleeding and serious heart attack. The study found Pradaxa users had a heart attack or chest pain in 237 out of 20,000 patients compared to 83 out of more than 10,000 patients taking Coumadin or a placebo.
To get a better handle on the complications, Pradaxa’s manufacturer, Boehringer Ingelheim is hoping to register about 56,000 patients in 50 countries to launch the GLORIA ™ – AF Registry Program, established to understand drugs to treat AF-related stroke “in a real world setting.”
Knowing that the side effects of the anticoagulant, Pradaxa, present a serious risk of excess bleeding and heart attack, it will be interesting to see how many patients the drug company can add to the registry. Other side effects associated with Pradaxa use include: