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A new study suggests that the bleeding risks from Pradaxa may be increased when the blood thinner is used in combination with the cholesterol drugs Zocor, Mevacor or Altoprev.
Canadian researchers indicate that combining Pradaxa with the statin-based cholesterol drugs led to a higher risk of major hemorrhaging. The findings were published this week in the Canadian Medical Association Journal (CMAJ).
Pradaxa is part of a new generation of oral anticoagulants, which has already been plagued by concerns about a high risk of bleeding problems, especially since the drug was originally released without an effective antidote that would allow doctors to reverse the blood thinning effects of the drug in an emergency.
At one time, Boehringer Ingelheim faced more than 4,000 Pradaxa lawsuits brought on behalf of individuals nationwide who suffered severe and sometimes fatal bleeding problems, alleging that the drug maker failed to adequately warn consumers or the medical community about the serious risk or lack of a reversal agent.
While the decades-old anticoagulant warfarin has a known and effective antidote, Pradaxa was introduced without an approved antidote, leaving many doctors helpless to treat bleeding patients who were prescribed the new anticoagulant. However, the reversal agent Praxbind was approved by the FDA last year, and became available in March, making the drug substantially safer.
In this latest study, researchers conducted two population-based, nested case-control studies involving nearly 46,000 patients age 66 or older who began taking Pradaxa between May 1, 2012, and March 31, 2014, and who also took a class of cholesterol drugs known as statins, which includes Lipitor, Crestor, Zocor, Mevacor, Altoprev and others. They looked at the rate of strokes and major bleeding events.
Researchers found no increase in the risk of strokes, but found a nearly 50% increase in the risk of major bleeding events among those who also took Zocor (simvastatin), Mevacor and Altoprev; both of which have lovastatin as the active ingredient.
The researchers theorize that these three drugs led to higher bleeding rates on Pradaxa than other statins because they are more potent inhibitors of P-glycoprotein and carboxylesterase. Both of those compounds cause the body to resist the absorption of Pradaxa’s active ingredient, dabigatran.
“In patients receiving dabigatran etexilate, simvastatin and lovastatin were associated with a higher risk of major hemorrhage relative to other statins,” the researchers concluded. “Preferential use of the other statins should be considered for these patients.”
Blood Thinner Litigation
Boehringer Ingelheim has faced sharp criticism and a number of product liability lawsuits alleging that they never should have sold Pradaxa without an available reversal agent. Similar Xarelto lawsuits and Eliquis lawsuits have also been filed against the makers of those other members of the same new class of anticoagulants, which still do not have antidotes approved by the FDA.
In 2014, Boehringer Ingelheim agreed to pay more than $650 million in Pradaxa settlements to resolve thousands of claims brought by individuals throughout the U.S. However, the drug maker has continued to face new lawsuits as injuries and wrongful deaths have continued to occur as a result of uncontrollable bleeding.
In December 2015, Portola Pharmaceuticals submitted a drug approval application to the FDA for a reversal agent that the company says will work on Xarelto and Eliquis bleeding problems as well. Known as Annexa (andexanet alfa), that drug was submitted after phase III clinical trials indicated it could stop most cases of Xarelto and Eliquis bleeding in minutes. However, the FDA has refused to approve the drug so far, saying it has questions about its effectiveness and manufacturing processes.