Nearly a year after looking into the safety of the blood thinner, Pradaxa, the U.S. Food and Drug Administration (FDA) reports that it appears to be as safe as its nearest competitor, the 50-year-old standard blood thinner, warfarin, commercially available as Coumadin.
The agency says in a statement dated November 2 that:
“The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).”
What is the FDA thinking about a drug that has been associated with more than 900 reports to the FDA of gastrointestinal bleeding, 300 reports of rectal bleeding, more than 200 reports of cerebrovascular bleeding and 542 deaths?
The Institute for Safe Medication Practices said Pradaxa had more reports of death or injury than any of the 800 drugs it regularly monitors.
Part of the problem may be with the way the FDA analyzed the risk. Using unadjusted incidence rate ratios, found in insurance and hospital claims, the FDA’s monitor, called the Sentinel Initiative, began in 2008 as a way for the FDA to monitor the safety of medical devices electronically.
Approved October 2010, Pradaxa was heralded as an improvement over warfarin because it did not require careful monitoring of the drug in patients with a heightened risk of stroke due to atrial fibrillation. But unlike Coumadin, whose effects can be reversed with a dose of vitamin K, there is no antidote for Pradaxa, which accounts for the more than 540 fatalities.
Instead of vitamin K, Boehringer Ingelheim recommends dialysis to flush the drug from the body, which may not be a practical solution is someone is bleeding to death.
The bad news/good news report have not put a damper on profits.
Pradaxa now makes up about 17 percent of the market compared to 44 percent for Coumadin.
Boehringer Ingelheim has seen this blockbuster drug generate more than a $1 billion in sales from the 725,000 patients who are using the drug, reports Pharmalot.