Almost everything about the new blood-thinning drug, dabigatran (Pradaxa) is novel.
In February, I wrote about the drug’s unusually short (thirty-day) expiration time. This week, the FDA has released a new communication concerning dabigatran. It included practical safety tips for patients, pharmacists and doctors, and is nicely summarized by Larry Husten, on Cardiobrief.
Here are a few of the more important points that jump out at me:
- Now, the FDA says that the potency of dabigatran is sixty days, not thirty.
- The potency of the drug relates to exposure to humidity. Dabigatran capsules should be left in the pre-packaged bottle and the lid closed tightly when not in use. This means the capsules should not be placed in pill boxes, nor should they be dispensed in regular amber pill vials.
- Patients who get ninety-day supplies of dabigatran should label the three bottles, and not open them until they are ready to start that month.
At first glance, you might think all this detail constitutes too much minutia.
Let me make two points:
Patient’s perspective:
For most patients, the strongest selling point of dabigatran is not its superior effectiveness in preventing stroke, but its convenience. Keep in mind that AF-patients with stroke risk factors often take other medicines. Something I learned from helping an elderly neighbor with her medicines is the complexity of compliance with multi-drug regimens. Though the short expiration dates, need for sealed containers and prohibition of organizing pill boxes aren’t deal-breakers, they certainly decrease the convenience gap between dabigatran and warfarin.
Doctor’s perspective:
In the use of dabigatran as a potent blood-thinner, doctors are clearly in the getting-used-to-phase. We know that dabigatran is superior to warfarin for AF patients that require a blood thinner. But the thing that we all are wrestling with is the notion of not being able to measure the thinness of the blood. “How do you know the blood is thin,” is a question that always comes up. The answer is: if the patient takes the dabigatran capsule (as directed) the blood is appropriately thin. This very new (and novel) paradigm emphasizes the importance of patient compliance. For dabigatran to be effective, real-world patients have to mirror the closely scrutinized patients that participate in clinical trials.
I am still solidly behind dabigatran, as are many of my heart-rhythm colleagues.
In fact, as of this writing, I have successfully done more than a few atrial ablations on patients taking dabigatran.
Stay tuned.
JMM
Carolyn Livingston says
April 8, 2011 at 12:45 pmWhat are the food restrictions with pradaxa as compared to Warfarin? Is grapefruit still on the NO list? I am currently stopping Warfarin to get it out of my system; will start with pradaxa when INR gets below 2. Some of the hazards listed in these sites are a bit scary.
Carolyn Livingston says
April 8, 2011 at 12:46 pmMy message disappeared — are there any food restrictions with pradaxa, such as grapefruit. I am off Warfarin until INR under 2. Should start on pradaxa next week.
Dr John says
April 8, 2011 at 3:43 pmThere are no food interactions with dabigatran. Drink all the GF juice that you would like.
Julia McAninley says
April 8, 2011 at 9:24 pmI am very concerned with not knowing how thin my blood is. How is this known without periodic checks as with couomadin?
Dr John says
April 8, 2011 at 10:15 pmThat’s the thing with dabigatran; it’s novel. Dabigatran thins the blood enough to prevent more strokes with fewer intracranial bleeds than warfarin–as demonstrated in the 18,000 patient RE-LY trial, 12,000 of whom took dabigatran.
Julia McAninley says
April 8, 2011 at 9:25 pmHow does one know how thin your blood is without check-ups?
george henderson says
April 9, 2011 at 8:02 amhow long do you have to wait to get off warfarin to take pradaxa. how many days
Dr John says
April 11, 2011 at 12:47 am36-48 hours.
lori says
April 9, 2011 at 7:27 pmAre green lefty vegies allowed . Also is this durg allowed when undergoing Chemo and radiation for cancer? I was on coumadin and required to replace that with Lovenox injections ? would i be able take this med and stop the injections Lovenox which the doctors have me on in place of coumadin while on treatment.
Cindy Delaurentis says
April 10, 2011 at 2:56 pmAfter 2 PE’s, one DVT & 3 TIA’s the doctors FINALLY called in a hematologist.
I have a Lupus like Anticoagulant/inhibitor s.He said the only treatment was coumadin the rest of my life! I’m wondering why he didn’t tell me about this new drug! Especially since I’m having severe side effects that are now worse the second time around. I am just now researching this new drug so maybe I should just keep on my search but would appreciate a faster answer from someone who knows the latest info on it. Thanks so much! Cindy
Dr John says
April 11, 2011 at 12:38 amCindy,
Theoretically speaking, dabigatran should be effective in your case. That said, I know of no rand.controlled clinical trials demonstrating a benefit. And, the FDA has approved dabigatran for the treatment of stroke prevention only in patients with AF.
Stay tuned for more news on expanding indications of the novel new blood thinner.