Question about generic drug...

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coffeelover

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Joined
Nov 14, 2011
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Does anybody have any comments/insights on the use of generic warfarin versus name brand Coumadin? Any advantage in using the name brand instead of generic? Thanks!
 
I have been on warfarin sodium for a very long time. Back in the "olden" days, and when Dupont Chemicals still owned the patent for Coumadin, they did a good job of "brainwashing" docs into believing that the generic warfarin was inferior to Couadin. As a result, I paid around $100/month(in the '70s,'80s, '90s) because my docs where "scared to death" to allow the generic. I did my own research wih the FDA, Bristol-Meyers-Squibb(current owners of Coumadin) and Barr Labs(one of several warfarin manufacturers) and could find little reason to continue paying the inflated price for Coumadin. I was told that the "active ingredients" in Brand or Generic had to meet the same tolerances, although there could be some differences in the "inactive ingredients". Finally, I found a young cardio who agreed that I could try generic warfarin. I have been on the generic, from at least three different companies, for about ten years with no effect on INR. I actually think I have been more stable under the generic, although I believe that is mostly due to my current docs being better at dosing. The BIG plus is that I now pay only $10/QUARTER for this med.
 
My research showed pretty much what **** outlined above. Then I talked to a few pharmacist friends that I trust and they confirmed that they have seen essentially no problems with the generic forms and would use it themselves if needed. My surgeon said the same thing. Unfortunately, there are still some docs around who will not, under any circumstance, allow the generic form. My mother-in-law has been on Coumadin ( name brand) for quite a few years because of afib and pays a pretty penny for it. When i told her I planned to use the generic form and why, she asked her doc to switch her. He told her she would have to find a different physician becasue he absolutely would not allow the generic and told her it was "rat poison". That flipped her out until i explained the facts to her. Quite a shame, in my opinion, that a practicing physician would act in such a manner.
My generic warfarin has been easy to manage so far with no surprises.
 
My doc automatically put me on the name brand Coumadin, and I appreciate that because chances are there that I will react
badly to inferior dyes or fillers in the generic. Since I don't take alot of meds the Coumadin seems like a good bargain to me,
and my insurance pays 80% of it.
 
Where is Bill B when you need him? ;)

There are patents on lots of drugs that have been released, which initially help companies that created/invented them to recoup their R&D costs. This is a pretty standard practice.
For example ACIPHEX, a proton pump inhibitor, had a 10-14 (I do not recall exactly) years patent which only allowed the inventor to produce and sell that drug. Once the patent expires or if the inventor cannot renew it, other companies can make it. The chemical formula and main ingredients are available and are listed in the patent (of course, this is how they can protect their property and enforce compliance), therefore, any other company can make a generic which would, at least, chemically, and most likely in process, be same as the original.

I am intimately familiar with several drugs, Aciphex included, which did not have generics for a very long time and people had to pay exorbitantly large price for to be on. I am also aware that once generics were available most people switch to them with no issues. Just some food for thought.
 
I have been on both and now have stayed with warafin due to my budget, the co-pay is cheaper, and it works the same as the coumadin. I have had no problems with either one, been on them for 11 years. So it is the chemical makeup that can make a difference also. Hugs for today.
 
.....Coumadin as the only available warfarin product until 1997. At that time, Barr Laboratories became the first company to receive FDA approval to manufacture and market a generic version of crystalline warfarin sodium.

http://pharmacistsletter.therapeuti...e.aspx?pc=06-36&AspxAutoDetectCookieSupport=1

Warfarin wasn't available as a generic until 1997. Doctors were (and still are) slow to warm up to using it. My wife is a pharmacist and wouldn't let me switch to generic until it was out a good five years. So unfortunately, dick0236, you were out of luck in the 70's, 80's, and most of the 90's. Wasn't really anything Dupont did or didn't do beyond making sure their patent stayed in effect for as long as possible. I've been on since late 1990 myself. No trouble with generics at all for the last 10 years or so.
 
Had I written this last week, I would have been on the side of others proclaiming that the generic is as effective as the patent version. I've even gotten warfarin from a pharmacy in India, until the $10 for 90 day generic programs came about at many local pharmacies. These pharmacies dispense basically the same warfarin that I was getting from India, but it actually cost less to get it at my local pharmacies -- was legal -- and was a lot less hassle. When I first received the generic, I was checking my INR more frequently than usual until I was comfortable with the equivalence of the generic and the patent Coumadin.

I few weeks ago, I refilled my 90 Warfarin pills. I was told by the pharmacy tech that the pills may not all look alike because they had to go with two manufacturers to fill my order. I didn't think much about it at the time. Now, I'm not so sure this was a good idea. My 4 mg pills (I have been taking 6 mg -- or 1 1/2 4 mg pills) every night at bedtime for months. My INR was fine when I checked it a few weeks ago.

Last week, I had a stroke. My meter showed an INR of 2.6. The hospital showed an INR of 1.7. I wonder if the generic from one of the manufacturers may have been colored wrong, or something, making it actually less effective than it was supposed to be. I don't know if the problem was a defective meter (which gave a value considerably higher than a hospital lab), or the generic, or just changes in my own metabolism.

Sure, Squibb did a great job of brainwashing doctors about the dangers of prescribing the generic. And, sure, they're using the generics elsewhere in the world without reported problems. IF I had medical insurance, or perhaps a new meter and strips, I may still use the generic unless my co-pay was close to the cost of generics. Otherwise, I'd stick to generic but monitor frequently just to be sure...
 
My doc automatically put me on the name brand Coumadin, and I appreciate that because chances are there that I will react badly to inferior dyes or fillers in the generic. Since I don't take alot of meds the Coumadin seems like a good bargain to me,
and my insurance pays 80% of it.

My system is similar to Bina's...does not tolerate the fillers and the dyes of the generics! Yet, Warfarin is OK. It is ithe only generic medicine I can tolerate and is working well.!
 
My system is similar to Bina's...does not tolerate the fillers and the dyes of the generics! Yet, Warfarin is OK. It is ithe only generic medicine I can tolerate and is working well.!

Eva, thanks for sharing that info. If ever I decide to switch to generic warfarin at least I know that it worked okay for you. (hugs)
 
My cardiologist suggested that generic drugs only have to have a certain percentage of the active ingredient (maybe 80%?) of the brand equivalents. She said this poses few issues for most drugs, but that for anticoagulation a difference of 20% could be huge. So when I recently requested a new prescription she wanted to keep me consistent with whatever I had previously. FWIW.

Best,
pem
 
Generic warfarin is listed as a NTI (narrow theraputic index) drug by the FDA and is considered a bioequivalent to coumadin. The NTI listing means it must meet more rigorous standards than the normal generic drug.....at least that is what my druggist told me. As with most other warfarin users, I have found no problem with using the generic....and the cost savings is nice too.
 
Generic warfarin is listed as a NTI (narrow theraputic index) drug by the FDA and is considered a bioequivalent to coumadin. The NTI listing means it must meet more rigorous standards than the normal generic drug.....at least that is what my druggist told me. As with most other warfarin users, I have found no problem with using the generic....and the cost savings is nice too.

That's great to know - thanks!
pem
 
Our thrombosis clinic was doing a large study of home monitoring. One of the results of that study showed that generic worked just as well as the name-brand.

HOWEVER, they did stress that you needed to stick with whatever brand you were getting if you wanted to maintain your INR because the different generic brands seemed to react at different levels. Therefore, if you noticed that your 4mg pills looked slightly different because it was a different generic brand that your pharmacy started getting, you would need to recheck to make sure that the dosage you were previously on was still working the same for you with the new brand.
 
I just checked online literature from both Bristol-Myers Squibb (owner of name brand Coumadin) and Barr (mfr of one of the generic warfarin sodium products). I have taken warfarin made by BMS, Barr, Taro and one other mfr of generic, never showed a difference in INR results when switching from one to another.

All the dyes are identical for each color. Only the 10mg is dye-free.

All the warfarin products marketed in the US are the same color for each strength. This avoids any confusion. I am not familiar with products marketed elsewhere in the Americas or overseas.
 
Eva, thanks for sharing that info. If ever I decide to switch to generic warfarin at least I know that it worked okay for you. (hugs)

You are most welcome, dear! You have always been of great help to me and to all, so I am glad to be of help to you.

As Marsha mentioned also, I got Warfarin refills from different manufacturers and I did not notice any difference! (hugs back)
:)
 
Had I written this last week, I would have been on the side of others proclaiming that the generic is as effective as the patent version. I've even gotten warfarin from a pharmacy in India, until the $10 for 90 day generic programs came about at many local pharmacies. These pharmacies dispense basically the same warfarin that I was getting from India, but it actually cost less to get it at my local pharmacies -- was legal -- and was a lot less hassle. When I first received the generic, I was checking my INR more frequently than usual until I was comfortable with the equivalence of the generic and the patent Coumadin.

I few weeks ago, I refilled my 90 Warfarin pills. I was told by the pharmacy tech that the pills may not all look alike because they had to go with two manufacturers to fill my order. I didn't think much about it at the time. Now, I'm not so sure this was a good idea. My 4 mg pills (I have been taking 6 mg -- or 1 1/2 4 mg pills) every night at bedtime for months. My INR was fine when I checked it a few weeks ago.

Last week, I had a stroke. My meter showed an INR of 2.6. The hospital showed an INR of 1.7. I wonder if the generic from one of the manufacturers may have been colored wrong, or something, making it actually less effective than it was supposed to be. I don't know if the problem was a defective meter (which gave a value considerably higher than a hospital lab), or the generic, or just changes in my own metabolism.

Sure, Squibb did a great job of brainwashing doctors about the dangers of prescribing the generic. And, sure, they're using the generics elsewhere in the world without reported problems. IF I had medical insurance, or perhaps a new meter and strips, I may still use the generic unless my co-pay was close to the cost of generics. Otherwise, I'd stick to generic but monitor frequently just to be sure...

Protime,

I am sorry to hear about your stroke. I hope all is well now.

Thanks for sharing. As you mentioned, I have become lately comfortable with my INR and thus I had been skipping a week or ten days before I prick myself again. After reading your story, I shall be more consistent with monitoring my INR weekly
 
Per a 2011 paper Institute for Clinical Systems Improvement "Health Care Guideline: Antithrombotic Therapy Supplement" April 2011

"Some equivalency studies have shown that substitution of generic warfarin for brand name Coumadin®
may provide equivalent anticoagulation response if the manufacturer of the generic warfarin has followed
the standards set for the name brand (Weibert, 2000 [A]; Yacobi, 2000 [A]). Care must be taken to remain
with either the brand name product or the same generic product. Do not switch from brand to generic or
between generics."

This is a survey paper, so what is relevant 12 years ago (citations from 2000) may not be true now. Probably a more current concept is that if you switch, test your INR.
 
A couple things -- thanks for the kind words, I'm working through the (fortunately minor) issue of a slight limp and hope to resolve it soon.

I strongly believe in weekly testing. The few times I didn't test that often during the past year or two, my 'late' test was often a surprise. I can't quite understand the belief that, if your INR is the same with a blood draw every month, your INR will be stable all the time between tests. With strips costing just a few dollars each (possibly less than driving to a lab and paying for parking), the idea of self-testing can be compelling to many people. For me, financially, it was the only choice.

When I first switched to generic, I carefully tested to see if there were any changes in INR. I don't recall any. When changing from one manufacturer's warfarin to that from another manufacturer, it's not a bad idea to waste a few strips and just be sure of the effectiveness of the new brand.

They've been using these generics in other countries around the world, and keeping people properly medicated. I don't remember hearing any horror stories about warfarin in other countries causing injury.

Like Reagan once said 'Trust, but verify,' this may be the same approach to take when switching to warfarin from a new manufacturer.
 
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