It's coming!!!!! FDA considering changing the label on Plavix
Posted Jan 07 2009 4:37pm
Did you hear? The Food and Drug Administration is in discussions with BMS and SanofiAventis to change the label in Plavix.....But here's the rub...
What do they say? The studies definitely show patients are at risk. The question is how many???
With Plavix being the second most prescribed drug in the nation this has left cardiologists jaws agape!
"life just got very confused and much more complex" for cardiologists and patients, said James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
"Once you know the answer what do you do?" said Douglas Weaver, head of the department of cardiology at Henry Ford Hospital in Detroit and president of the American College of Cardiology. He said there aren't any alternatives to Plavix approved in the U.S. A potential alternative, ticlopidine, is rarely used because it has been associated with serious blood disorders.
Oh, Doctor Weaver, if you only would read the Sherpa,I recently gave you 4 options of things you could do......just because we don't have rock solid evidence behind it doesn't mean we can't do these things....and when the FDA label changes, you better get ready for the trial lawyers!!
"Clearly I think just the blind administration of these drugs is rapidly coming to an end," said Paul Gurbel of Baltimore's Sinai Hospital
That's music to my ears!!!!
To quote my very first post:
So I have no idea where to begin. Which is why I will just start with the Stats.......
Only 17% of patients with familial colon cancer risk were referred to appropriate genetic counseling according toa study at Harvard.
We have a lot to cover and I look forward to sharingmy solutionto this huge problem. How in the world can we expect to implementPersonalized Medicine in all its glorywithout having some Genome Savvy physicians? Oh....Those geneticists? Too bad almost 90 percent are pediatricians and have no clue what ischemic heart failure is.(Or Plavix )
The Sherpa Says: I see that lawsuit creeping closer and closer......We need some educators and damn fast! The durg -drug interaction with PPIs has been a possibilty for years, the gene-drug interaction too....now what about the gene-drug-drug????