warfarin (coumadine / marevan) and the modern world

[pellicle]

Hi

my sister-in-law (who works for a pharmaceutical company) mentioned to me the other day that she was told that warfarin would probably be unlikely to be approved were it introduced today.

I thought this was interesting, and wondered if this is because it is somehow more dangerous than alternatives (like Xarelto) or if our procedures are now so tight that many things which are helpful would not be allowed.

I recall reading some years ago that if Petrol (the Americans will know it as Gas even though its a liquid normally ;-) were proposed as a fuel source today it would not be approved.

thoughts?

 

[Gary Miller]

I have been on Coumadin since the surgery (15months) and recently bought a 90 day supply of warfarin (Tero I believe) to see if it was comparable for me and didn't change my INR dosage that drastically. It is considerably cheaper than Coumadin and if my prescription benefits change when I reach 65 and go on Medi-Care I will surly have to consider it very seriously.

 

[tom in MO]

What does she base that statement on?

It certainly has been proven effective and safe when used as directed.

I don't know about Australia, but in the US every drug is reviewed once a year to see if it is still viable. That's why some drugs come out, are used for many years, but then disappear.

 

[pellicle]

Hi Tom

What does she base that statement on?

well she's in sales and so has no pharmacology or pharmacokinetics knowledge. Its probably some biased viewpoint pushed by the pharmaceutical company she works with...

I should update my status, I'm in Finland now. I've come to where my wife was from to be with family here.

 

[Protimenow]

Actually, we call it gasoline (which still makes it liquid, rather than vapor). Of course, if you spill some on the ground when you pump it on a hot day, the name 'gas' is pretty accurate.

I've been using generic 'coumadin' for years. When I changed from patent Coumadin to generic Warfarin, I tested my INR to confirm drug equivalence. The manufacturers of warfarin are careful to make sure that their numbered tablets have the same biological effectiveness as Coumadin. There may be differences in dyes and binders in the pills, and some people MAY have had sensitivities to these components, but the functional effectiveness of generic and patent warfarin MUST BE equivalent for the manufacturers to be able to continue making the medication.

Coumadin has a very small window of effectiveness - this may make it a bit hard to regulate, but as others have said, when used properly it is both safe and effective.

I doubt that the approval of warfarin - even if it was developed today - would find a lot of regulatory hurdles. True - it's an interesting drug, with a small window of being ineffective or overly effective, and with a wide range of doses being offered (which may confuse the FDA), but I don't see it NOT being approved.