FDA Just Changed Warfarin Label – There’s A Device For Those With Atrial Fibrillation that Can Replace the Drug

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 Watchman implanted 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.

Medicare has Decided Against paying for the Genetic Warfarin Test For Now

This was the post from last year at about this time.

Atrial Fibrillation – What will be the future standard of care, Warfarin or the Watchman Device?

This requires an interventional procedure. After the device is put into place, additional measurements and pictures will be taken to make sure the device is in the correct position. Once your doctor has confirmed the position, s/he will release the device to leave it permanently implanted in your heart. The device may not be the answer for all, and we will still need drug blood thinners outside of AF, but 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. Again, this is potential good news for many, but for the other side of the coin, the 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 enough, evidently, so now, with pretty minimal evidence, FDA 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 exists, as far as I know, is 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 study, meaning that clinical outcomes were not improved by the pharmacogenomic testing.”