Pradaxa® was first approved in October 2010 by the U.S. Food and Drug Administration (FDA) to help prevent strokes. About 16% of patients with atrial fibrillation (irregular heartbeat) were taking Pradaxa® after the first year on the market, compared to the 44% of patients who were taking warafin, the more traditional blood thinner medication.
XARELTO® then joined the anticoagulant market when it was first approved in July 2011 by the FDA for use in patients who had undergone hip or knee replacement surgery. The drug’s purpose was to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolisms (PE). Following a fast-track regulatory review, the FDA approved expanded use of the drug for patients with atrial fibrillation (A-Fib), DVT, and PE to reduce the risk of stroke.
In 2012, more than 3.7 million prescriptions for Pradaxa® had been issued to patients across the U.S., after the manufacturer spent $464 million to promote the drug in 2011. By this time Pradaxa® was alleged to have caused more than 500 deaths as patients reported instances of hemorrhaging and uncontrollable bleeding. According to QuarterWatch, 500 adverse events related to bleeding occurred in 2011, all of which resulted in serious injury or death. Additional reports in 2012, published by the Journal of the American College of Cardiology, revealed there is a higher risk of a heart attack for patients taking Pradaxa® compared with warafin.
In regards to XARELTO®, its expansion of use was granted despite the fact that in May 2012 an FDA advisory panel recommended against doing so because “concerns over dangerous bleeding outweighed evidence that the drug helped reduce the risk of blood clots in patients with serious heart problems.”
Steven Nissen, MD, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was a panel member who voted against expanding the use of XARELTO® in patients with acute coronary syndrome. This condition occurs when a blood clot blocks a vessel leading to the heart, depriving the heart muscle of oxygen.
“We really want to have very compelling evidence” that the XARELTO® helps patients, Dr. Nissen told The New York Times. “Evidence of increased bleeding should not be taken lightly. When the bleeding is in the brain it can lead to irrevocable damage, a complication that some consider worse than death.”
The panel was also concerned about a study that Johnson & Johnson submitted in which 15 percent of the patients dropped out, leaving the data’s reliability in question.