FDA OKs Kcentra: New Drug to Quickly Stop Acute Coumadin Bleeds

For those of us who take the blood thinner warfarin (brand name Coumadin) or similar drugs to prevent prevent clots, one of the scariest of life’s scenarios is an accident or fall. It’s especially scary for patients like me who, because of an acute tendency to clot, must keep their blood extra thin to prevent stroke or heart attack.

In the twelve years I’ve been taking warfarin, I’ve had many bleeding incidents, three of them serious.  One,  which my doctor feared was approaching the dire “compartment syndrome,” kept me in bed for five weeks.

Now, there’s a new weapon in our battle to keep healthy.

Yesterday,  the U.S. Food and Drug Administration  approved Kcentra (Prothrombin Complex Concentrate, Human) for the “urgent reversal” of vitamin K antagonists like warfarin  in adults with “acute major bleeding.” Plasma is the only other product approved for this use in the United States, the agency said.

Like plasma, Kcentra is used in conjunction with vitamin K to reverse the anticoagulation effect and stop bleeding. The advantage of the new drug is that, unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma. In addition, Kcentra is administered in a significantly lower volume than plasma at recommended doses. This will benefit patients who may not tolerate the volume of plasma required to reverse the anti-coagulation.

So, for someone with a life-threatening bleed, Kcentra may offer a advantage. I’ll be anxious to talk to my doctor to hear his thoughts.

The down side of Kcentra is the possibility of blood clots,  even when used properly.  That’s a special concern of mine, since the disease that caused my stroke—Antiphosoholipid Syndrome (APS)—is especially prone to clotting under traumatic conditions. Sudden reversal of anti-coagulation could put me at very high risk of another stroke. So my personal strategy, worked out with my doctor,  won’t change: watch my blood thinning like a hawk; get my INR (a measure of blood thinning) tested frequently; try to avoid falls or accidents; and in case of  bleeding that’s not life-threatening, reduce or stop the warfarin (in close consultation with my doctor) and let my INR  drift down gradually.

But for those of us taking Coumadin, life-threatening bleeding is a real possibility. So even though I’ll try hard never to need it, I’m glad for the treatment alternative Kcentra presents.

You can read more about Kcentra here.