A recent study found no severe hemorrhagic complications in patients who underwent cutaneous surgery while continuing to take the anticoagulant Pradaxa.

The study was conducted by researchers at the Mayo Clinic. They reviewed the medical records of 27 Pradaxa patients who underwent either Mohs micrographic surgery or basic excision at Mayo between January 2010 and September 2013.

Both types of surgery are used to remove potentially cancerous skin growths. In Mohs micrographic surgery, one thin layer of tissue is removed at a time. In basic excision, an oval-shaped section of skin is cut out and the remaining void is sutured shut.

In the 41 cutaneous surgeries performed on the Mayo Clinic patients, there was only one minor Pradaxa bleeding complication, resolved after application of a pressure dressing. Based on the absence of serious Pradaxa complications and the potential for severe thrombotic complications if Pradaxa were stopped, the researchers concluded that continuing Pradaxa during cutaneous surgery seems reasonable.

What is Pradaxa Used For?

Pradaxa, also known by its generic name dabigatran, is an anticoagulant medication made by Boehringer Ingelheim Pharmaceuticals. It has been on the market since the FDA first approved it for sale in October 2010.

Pradaxa is now indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat pulmonary embolism and deep venous thrombosis, and to reduce the risk of recurrence of both those conditions.

Atrial fibrillation often calls for treatment with anticoagulant medications like Pradaxa. By disrupting blood flow through the heart, atrial fibrillation increases the risk that blood clots will form and travel to the brain, possibly causing a stroke. Pradaxa reduces that risk by inhibiting the blood’s ability to clot.

Pradaxa Bleeding

Pradaxa is the first of a new generation of anticoagulant medications that recently entered a market long dominated by Warfarin. Since 1954, Warfarin (also sold under the brand name Coumadin) had been the go-to anticoagulant medication for preventing stroke in atrial fibrillation patients.

Warfarin had a disadvantage, though, in that patients were required to undergo regular blood tests and dosage adjustments. Newer anticoagulants like Pradaxa do not require such ongoing testing.

The Mayo Clinic study addressed a problem that Pradaxa shares with all anticoagulants: they increase the risk that any bleeding that occurs during anticoagulant treatment may be excessive. This risk of excessive bleeding can make surgery more complicated.

Patients who need surgery while on anticoagulants may have to temporarily discontinue that medication, which may increase the risk of thrombotic complications.

The potential for excessive Pradaxa bleeding during surgery is exacerbated by the unavailability of any other drug that will reverse its anticoagulant effect – a so-called “reversal agent.” Bleeding caused by Warfarin can be counteracted by administering Vitamin K. However, when excessive Pradaxa bleeding starts, the patient must discontinue treatment and wait for the body to completly metabolize the drug.

Boehringer Ingelheim Pharmaceuticals is developing a potential Pradaxa antidote called idarucizumab. The company filed for FDA approval of that drug in March 2015, and that approval process is still going on.