FDA Just Changed Warfarin Label – There’s A Device For Those With Atrial Fibrillation that Can Replace the Drug
Posted Feb 11 2010 7:48pm
As is indicated again the Warfarin dosing for blood thinning label has changed. Perhaps the future is an implanted device? Last year I did a post about the Watchman and a year later there are actually 5 people walking around with a Watchmanimplanted in the UK. This was also a set back for the pharmacogenomic test with Medicare deciding not to pay. Here we are back to money. Last year I can’t count the number of stories on Warfarin.
This was the post from last year at about this time.
This requires an interventional procedure. After the device is put into placeadditional measurements and pictures will be taken to make sure the device is in the correct position. Once your doctor has confirmed the positions/he will release the device to leave it permanently implanted in your heart. The device may not be the answer for alland we will still need drug blood thinners outside of AFbut it does represent a potential winner for those affected with Atrial fibrillation that take blood thinners.
In the UK all patients who have AF and are prescribed warfarin are eligible for the implant on the NHS an you know we won’t get anywhere near that deal here. It has not been approved by the FDA here in the US yet. Againthis is potential good news for manybut for the other side of the cointhe genomic testing for the drug seems to be up in the air and getting more complicated by the day as far as what is an appropriate dose for one of the most difficult drugs to monitor. BD
“The changes in 2007 suggesting pharmacogenomic testing didn't go far enoughevidentlyso nowwith pretty minimal evidenceFDA has gone ahead and upped the ante with specific recommendations for starting doses depending on the VKORC polymorphism profile. They cite "multiple studies" to justify a dosing table (!)which is news to me. The only evidence that existsas far as I knowis a 2009 clinical trial that showed patients stayed within a therapeutic INR for more time when pharmacogenomic dosing was used. There was no difference in bleeding or thrombosis in that studymeaning that clinical outcomes were not improved by the pharmacogenomic testing.”