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FDA investigating the safety of Benicar
 Moderated by: Prof Trevor Marshall Page:  First Page Previous Page  1  2  3  4  5  6  7  8  ...  Next Page Last Page  
 

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gart
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 Posted: Sun Jun 27th, 2010 09:42

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I had collected  a  stockpile for 6 months of Benicar samples given me by my cardiologist and physician.It doesn't says when I should to discard and I don't know how long it stayed in doctor's offices.It is factory packed with aluminum seal on the top , seven tablets in bottle. They looks absolutely perfect, white and solid.Can I use them?

 Thank you.Gene



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Freddie Ash
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 Posted: Sun Jun 27th, 2010 10:20

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HI GENE

This is Fred in WV.  I get some of these samples from my family doctor from time to time to make sure I do not run out.  If you look on the side of the bottle there should be:  

                  LOT NUMBER
                  EXP DATE - Like the one I am looking at right now has 05/11

So you should be able to find an exp date telling you when you should not use it.  I hope this helps.

Remember, we are all in this together and I am pulling for us.

Your friend in Sarcoidosis
Freddie



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gart
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 Posted: Sun Jun 27th, 2010 14:49

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Hi Freddie.

Yes,  I found it.

Thank you very much.

Gene



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madhouse
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 Posted: Sun Jun 27th, 2010 18:57

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There is a discussion about this over on Bacteriality with Amy and a research scientist. He says it is most likely going to get pulled. It is not a very widely used drug and Daiichi Sankyo is not going to put up much of a fight.

There are many other anti-hypertensives on the market so who cares!



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Phillyguy
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 Posted: Sun Jun 27th, 2010 19:57

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madhouse wrote: There is a discussion about this over on Bacteriality with Amy and a research scientist. He says it is most likely going to get pulled. It is not a very widely used drug and Daiichi Sankyo is not going to put up much of a fight.

There are many other anti-hypertensives on the market so who cares!


With respect to a comment made to Amy by this researcher:

Tim Ayers made the following comment: 

"I do however find it hard to believe that it would do alot of interaction invivo. Olmesartan is very tighly bonded to the AT1 receptor as it was designed to do. Considering the volume of distribution of olmesartan and the amount of AT1 receptors that sample the blood stream it is unlikely that any of the drug is available for interaction with other weaker ligands…..remember that at typical doses (even 3 times the normal dose as you suggest) there is still 100s of times the AT1 receptors as there is drug in the serum. This is further compromised as blockade of AT1 leads to an up regulation of AT1 on vascular SM cells…thus as time goes by there are more and more recptors available for bonding."

http://www.ncbi.nlm.nih.gov/pubmed/18078928

Moreover, angiotensin AT(1) receptor antagonist dose-dependently inhibited TNF-alpha-induced PAI-1 production. Interestingly, high-dose olmesartan, but not candesartan, reduced the increased expression of the angiotensin AT(1) receptor.

Of course we now know per the Kidney International paper that VDR activation downregulates the AT1 receptors....

Prof Trevor Marshall
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 Posted: Sun Jun 27th, 2010 21:42

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Dody wrote: I just think we need to keep our cool and view this as what it is: a potential problem requiring problem-solving skills. We are collectively and individually very good at problem-solving.

I have just arrived in Maryland, ready for the presentation I will be giving at the FDA on Tuesday. Amy is joining me here tomorrow.

The video should be on YouTube by the weekend...

..Trevor..

positiveminds
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 Posted: Sun Jun 27th, 2010 21:57

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I had a read of this discussion which is very interesting indeed. Tim Ayers makes some excellent points and it's interesting to hear about the "grumblings" that have been going on about olmesartan for years. He is an industry insider and predicts olmesartan will be pulled within 6-12 months. This has now put us all in a terrible position, because once pulled it will take many years and lots of $$$ to do the studies to get it back. Why would a big pharmaco do that when, according to Tim, sales aren't very good anyway? Tim makes some good points about the lack of proper research to convince these scientific bodies of the safety of olmesartan. I can't imagine the FDA deciding to allow continued use of olmesartan because of the theories put forward by ARF when there is clinical evidence mounting against it's safety.

I think we all need some answers now. We have trusted that the ARF is doing everything in our best interests, but the fact this is happening is proof ARF is behind the 8-ball. People have long been asking for proper clinical proof, and because none have been produced, we are in trouble.

I, for one, can't imagine surviving long without the MP. I have no desire to function like that again. I'm not sure if others are thinking similarly, but I had made a decision before I started the MP that if I couldn't find a cure for whatever the he'll was going wrong with me, I would take my life. That was the only hope I had of escaping the suffering, and now that seems a real prospect again. I'm sorry Trevor, but we need answers.

What happens if olmesartan is pulled from the market? What do we do?



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Prof Trevor Marshall
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 Posted: Sun Jun 27th, 2010 22:09

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Look, I don't have time to look into this Tim fellow, and who he is, but he is dead wrong when he postulates that all the Olmesartan would be bound by the Angiotensin receptors. The obvious reason he is wrong is that if so, all the ARBs would be identical in their actions, which they are not. Clearly they affect other receptors, each ARB in its own particular way.

Sankyo sells a billion (1000,000,000) dollars worth of Olmesartan a year. To the USA alone they ship 26 tons of the product every year. He is wrong about the size of their market. take a look at the market sizes I posted after i got back from the sartans summit in Shanghai earlier this month :)
 
http://marshallprotocol.com/view_topic.php?id=13788&forum_id=39

I am still taking Olmesartan. My brain is still getting clearer (and calmer) month by month. I suggest it would be a good idea to wait until you see me start to get worried, and not listen to some self-appointed 'industry-insider' :)
 
 

Last edited on Sun Jun 27th, 2010 22:17 by Prof Trevor Marshall

Joyful
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 Posted: Mon Jun 28th, 2010 02:00

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It should be obvious that the types of studies that would get the attention of the FDA nearly always require funding levels only available to the researchers that work within the current mindset on chronic disease. And the foundation has worked hard to get what they could with the orphan status designation on two antibiotics for sarcoidosis in March of 2006. Countless hours have been spent working on applications and then reworking each time they are rejected.

Please do note that Dr. Marshall has already said the foundation is working hard behind the scenes to be proactive in this. I have a great amount of confidence that the foundation will find a way to deal with whatever comes down the line.

Let's not borrow from tomorrow's trouble ... may I suggest that we all keep "positive minds" concerning the issue. :)



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positiveminds
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 Posted: Mon Jun 28th, 2010 02:43

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I should change my monicker to "realistic minds." I don't mean to be negative, but these are some valid concerns, I think.

What you say Joyful is exactly what I fear - that those bodies with the money will spend it on proving Benicar's dangers before any research will be produced confirming the MP's hypotheses and hence Benicar's safety, and if Benicar is withdrawn we and the ARF are firmly on the back-foot and I doubt the ARF has the funding to do anything much about it.

If "tomorrow's trouble" wasn't related to my health and ability to function in the world and live a life free of suffering, I wouldn't worry so much. I really do hope the ARF have a back-up plan for the worst-case scenario of Benicar being withdrawn from the market, but I just don't see how they could do anything about it if that happened, with all due respect. Again, the FDA would not be investigating were they not considering withdraing the drug. At this stage, it appears the evidence is in our favour, but that could change.

I'll butt-out for now, and will try to stop worrying. But I've held these concerns for some time and now that this FDA investigation is happening, wanted to air them.



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Joyful
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 Posted: Mon Jun 28th, 2010 02:49

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Your concerns are all of our concerns as well. It's just so damaging to our diseased bodies to allow anything to provoke a stress response. :?



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Prof Trevor Marshall
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 Posted: Mon Jun 28th, 2010 03:10

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Positiveminds, let me repeat what I said above. Wait for the announcement. We are best to work within the system right now, and the cogs of progress turn very slowly. But there has been progress, and my first priority has always been to protect our members...

Dody wrote: I just think we need to keep our cool and view this as what it is: a potential problem requiring problem-solving skills. We are collectively and individually very good at problem-solving.

I have just arrived in Maryland, ready for the presentation I will be giving at the FDA on Tuesday. Amy is joining me here tomorrow.

The video should be on YouTube by the weekend...

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 Posted: Mon Jun 28th, 2010 03:59

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Keep in mind also that just because a med is taken off the market in the US doesn't mean that it is a death sentence for the drug. 

For example in 1994 when my son was an infant he was diagnosed with colitis and severe GERD and by 3 months was taking a new drug that had been recently approved by the FDA.  The drug was called propulsid. 

 http://www.rxlist.com/propulsid-drug.htm


It was the only drug that worked in the way the GI docs wanted for him at the time to control his severe GERD.  He used it for about 3 years until I read a new study regarding its safety in connection with LQTS.

http://en.wikipedia.org/wiki/Long_QT_syndrome

My family has a history of LQTS and eventhough my son had tested negative by EKG I hadn't had the genetic screening done yet to eliminate the possiblity of him having a genetic marker.  Since he had made great strides by then I discontinued his taking the drug.  By 2000 the drug was voluntarily withdrawn from the US market but the maker didn't stop selling it.  Today it is still available via the internet and used in many countries.  Looks like I could buy it if I wanted and have it sent in.  This is just one example I could give you more.  I even found Vioxx online and we all know the story of that.

As long as there is a market for a drug someone will produce it and sell it.  That is the economics of it regardless of what the FDA says.

So even in what would be the worst case scenario.  Where there is a will there is a way. 

Karen





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 Posted: Mon Jun 28th, 2010 06:04

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I do not post very often, but I can't sit on the sidelines on this one.   Having worked for the FDA for most of my career I can tell you that once a drug is on the market it is very difficult to get it removed, and here I am talking about some real bad stuff.  Putting that aside for a moment you have to recognize, and if you don't or can't, you have to trust that what I am about to tell you is correct.  Olmesartan, was and  still is one of the safest drugs on the market.  Even the so called experts have come out on this recent study release saying that they will not be changing how they prescribe this medication.   Unfortunately, "Tim" does not have a good grasp or understanding about what he is talking about.   At the moment I must drop this dicussion because I am in the middle of something else.  I will be on later today.  In the meanwhile for those of you worried, and to those of you needlessly worrying others, there is no need for this alarm.  I ask you to trust me on this one and get back to your real lifes.   I will be on later today.  Joyful, if this message needs to be also placed on Bacteriality, please do so.  I really have to go for the moment, but you can reach me on my cell if you need to.    Thank you



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titta
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 Posted: Mon Jun 28th, 2010 06:06

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Hello all,

whatever happens, in this forum there are so many people with different backgrounds and abilities that we all together will find ways.

I want to mention that I am full of respect for what the ARF has done.
Despite a lack of money so much has been achieved by those active.
Thank you for that.

Titta



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positiveminds
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 Posted: Mon Jun 28th, 2010 06:45

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I don't think i'm needlessly worrying others. I think what i'm doing is airing valid concerns I have, and trying to get answers for myself and others with similar concerns about this, which I believe i'm entitled to do on a public discussion forum. Many of us have had to take our health into our own hands and do not trust medical professionals. I have much respect for Dr Marshall and his team, but that does not mean we cannot be critical or question what is happening. We didn't have this information before. I don't know how the FDA works from the inside so I think my concerns were valid. Also, there is a lot of criticism out there about the MP and ARF, including from people previously working for the ARF, so it's hard to know what is what from a lay-perspective and I think we are entitled to be critical and ask for answers and more transparency in what the ARF is doing, since our lives (or quality of life) depend on it.

Joyful - I wouldn't say i've provoked a stress-response over this one, just airing some reasonable concerns, in my opinion.

Perezt, I'm living my life, still working etc, thank you. I just think we need some answers to settle worried minds, and your post, giving us a little insight into the workings of the FDA, helped.

Perhaps i'm the only one with these concerns? Perhaps i'm being completely irrational and neuro-herxing? If so, I apologise for taking up this thread with my worries. 

Last edited on Mon Jun 28th, 2010 11:04 by positiveminds



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 Posted: Mon Jun 28th, 2010 07:51

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The discussion on this subject at the bacteriality site can be read, starting with the third post down, at:

http://bacteriality.com/2010/06/01/symbiosis/

Sherry

Personally, I feel much better after reading the discussion at bacteriality.



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Aunt Diana
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 Posted: Mon Jun 28th, 2010 09:12

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Question: can the shelf-life of Olmesartan be extended by freezing it, or refrigeration?



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Prof Trevor Marshall
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 Posted: Mon Jun 28th, 2010 09:27

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Lowering the temperature of a chemical reaction will slow its rate. I would expect the same with Olmesartan Medoxomil, which tends to form an Olmesartan dimer, and other decomp components which are not harmful, in any case. Freezing a drug is a little dangerous, as there is a good chance that moisture will enter the equation at that point :)

The problem is that the medoxomil ester is trying to break the olmesartan backbone in half:


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 Posted: Mon Jun 28th, 2010 15:54

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I had the sales rep ask the pharmacist whether freezing or refrigeration of Benicar was a good idea.  He recommended that I do neither as long as I had air conditioning or a cool place (like a cool closet or dry basement).  Whatever the case, freezing was definitely out.  Just relaying what I heard today....



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