brand vs. generic

[Ter]

This may have been addressed before, but I am new to the forum.
I believe the FDA allows 20% variation above and below the stated drug level for generic drugs, and this worries me. Of course, insurance companies charge much less for generic drugs, and I am using warfarin from Barr. Sometimes, the generic drug is produced by the same company that makes the brand drug. Does anybody have any thoughts on the subject.

I have been on warfarin for a month now, and have had many, many INR's drawn, as we try to stabilize my INR. Had to go off it for the cardiac cath, then restart after the procedure, and will have to go off again for the valve repair surgery - and then go on it again. Can't wait to reach a point when I don't have to get stuck constantly, but am grateful that my primary care doctor is working with me and is so careful and attentive (and the nurse who calls me does listen to my input as well).

Thanks, Terry

 

[ALCapshaw2]

There have been MANY discussions of this topic in the past.
Do a Search (see the Blue Line at the top of the page) for "Generic" in the Anti-Coagulation Forum and you should find links to many posts on the subject.

Bottom Line: MOST of us report NO Difference.

BARR (USA) and TARO (Israel) are two of the be better manufacturers of Generic Warfarin. I've used both with NO CHANGE.

Also see AL Lodwick's website www.warfarinfo.com to learn all you need to know about living on/with anti-coagulation. His Dosing Guide ($5) is the best money you could spend on anticoagulation care.

'AL Capshaw'

D

 

[BDMc]

Hi Terry, My experience is like Al's. Years ago there was a class action suit against Dupont because they told doctors the generics were not safe. The legal consensus is that they are equivalent. Brian

 

[KristyW]

Ter,

I don't believe that the variance is as much as 20%. I think it's more like 10%, but check www.warfarinfo.com to be sure. With that said, we all absorb and process warfarin/coumadin at different rates. It's more important that you stay with one manufacturer if possible. If you're taking generic warfarin, just monitor your INR when your pharmacy switches manufacturers. My supposition is that the amount of medication per dose is consistent for each manufacturer ie. Barr, Taro, etc..

 

[Eva]

Terry,

Welcome aboard and good luck with everything. Before I left the hospital I asked the doctor in charge of ICU about Warfarin and that my body does not like in many cases generic meds...his answer was that Warfarin is made by the same company of Coumadin!!

 

[ChouDoufu]

http://counsellingresource.com/medications/discount-drugs/generics.html

1. Bioavailability

Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioequivalence is a comparison of products with respect to their bioavailability. Bioequivalency means that the same amount of active ingredient is delivered to the body by the generic medication as by the brand-name drug.

The FDA requires that the generic medicine have a comparable bioavailability to that of the brand-name drug, but NOT the exact bioavailability. Legally, bioequivalence of different versions of a drug can vary by up to 20%, because for most drugs, such variation does not noticeably alter effectiveness or safety. This means that one generic may have achieved values that lie between 80% and 100% and another values that lie between 100% and 125%.

http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr320_00.html

Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

 

[Ter]

Thank you all for your advice. I am obsessed with my INR at the moment, and expect that over time I will be able to calm down.

 

[olefin]

Question

Question

I get my drugs at a discount through VA. I've noticed in the last year or so that I don't see DuPont on my Coumadin pills.

So is this a generic that I'm getting from VA?

In the past when I was paying full price I would get a sealed container of 100 pills labeled Coumadin from DuPont. Each pill was label Coumadin and DuPont.

 

[catwoman]

I get my drugs at a discount through VA. I've noticed in the last year or so that I don't see DuPont on my Coumadin pills.

So is this a generic that I'm getting from VA?

In the past when I was paying full price I would get a sealed container of 100 pills labeled Coumadin from DuPont. Each pill was label Coumadin and DuPont.

What shape are your pills?

Coumadin (brand name) tablets are round and (I'm sure) say Coumadin.
Barr tablets are elongated and pointed at the ends and say barr (with a lower-cased b).
Taro tablets are elongated and the ends are rounded and say TARO (all caps).

 

[afraidofsurgery]

been there done that

been there done that

I used Coumadin the first 2 years post-surgery then got tired of paying the extra $$ for the brand name. I consulted with my cardiologist, who is conservative and aware of the theoretical issues with generics. BUT he wrote a 3-month Rx (also useful for mail-order or Walgreens deals) to minimize variations. Most of the issues arise with differences between brands or lots when refilling - one refill will all come from the same big bottle.

I've had rock solid INR since switching and have more $$ in my pocket

Patty

 

[Tbone]

I,m not sure of the variation tolerances; however, if you are worried talk to your pharmacist to see what he carries. Than talk to your doctor to see what is best for you. It is important not to switch brands. You can always have your doctor write DAW on the prescription. DISPENCE AS WRITTEN

 

[Bina]

I only pay 25% of my Rx and I don't mind paying the extra for Coumadin....whether generic or brand name, just make it consistent.