Aa
Oxycontin having probs with new formula
Hi all-
After years of working with my doctors we finally found a medication combo that has worked well for my chronic head pain.
I take Oxycontin 30 mg, three times a day, Hyrdromorphone 4 mg (up to 4 a day) for break through and Topamax 50 mg at might. Last Friday I got my meds. All week, I've been suffering and the pain relief has been only about 1/2 of what it was before. And yet, I am also feeling more sedated than before.
Today, I called my doctor and I will see him on Monday. The nurse mentioned that a lot of patients have been having problems with the new formula of oxycontin. So AHA, that's what it might be.
Are other patients having this problem? And if so what are your doctors doing to help? I just want some ideas for when I see my doc on Monday. Thanks
Horselip
So my question is
After years of working with my doctors we finally found a medication combo that has worked well for my chronic head pain.
I take Oxycontin 30 mg, three times a day, Hyrdromorphone 4 mg (up to 4 a day) for break through and Topamax 50 mg at might. Last Friday I got my meds. All week, I've been suffering and the pain relief has been only about 1/2 of what it was before. And yet, I am also feeling more sedated than before.
Today, I called my doctor and I will see him on Monday. The nurse mentioned that a lot of patients have been having problems with the new formula of oxycontin. So AHA, that's what it might be.
Are other patients having this problem? And if so what are your doctors doing to help? I just want some ideas for when I see my doc on Monday. Thanks
Horselip
So my question is
Hi Designgyrl-
Thanks for your post. And yes I have tried other things but unsuccessfully. I don't have migraines though.
An area of nerves in my brain were damaged from a pituitary/hypothalamic cyst that exploded. The doctors at the Pain Center where I go have explained my situation as being something similar to trigeminal neuralgia but with slightly different nerve branches,
They have tried several nerve blocks. The sphenopallatine nerve is one of the culprit in my case. They are looking into doing a radio frequency ablation of this nerve, but the technique is not fully developed yet.
So while not perfect, the narcotic medication provides welcome relief. I have also been trained in how to apply lidocaine into my sinuses with long q-tips through my nose. This numbs out the area when I am at a "10". The problem with that is that it numbs my whole face and is really weird as a long term thing.
Are you aware of other treatments for this type of head pain? I am more than open to any and all suggestions!
Horselip
Thanks for your post. And yes I have tried other things but unsuccessfully. I don't have migraines though.
An area of nerves in my brain were damaged from a pituitary/hypothalamic cyst that exploded. The doctors at the Pain Center where I go have explained my situation as being something similar to trigeminal neuralgia but with slightly different nerve branches,
They have tried several nerve blocks. The sphenopallatine nerve is one of the culprit in my case. They are looking into doing a radio frequency ablation of this nerve, but the technique is not fully developed yet.
So while not perfect, the narcotic medication provides welcome relief. I have also been trained in how to apply lidocaine into my sinuses with long q-tips through my nose. This numbs out the area when I am at a "10". The problem with that is that it numbs my whole face and is really weird as a long term thing.
Are you aware of other treatments for this type of head pain? I am more than open to any and all suggestions!
Horselip
Have you tried anything else than narcotics for your head? The reason why I'm asking is my friend has headaches (migraines from unknown source daily) and they told her narcotic is the worst thing that she can take for them. They have been able to medicate her with benadryl, Savella, DHE, Ativan, and a muscle relaxer and her headaches are almost gone. She does them by injections but I just wondered because you were talking about all the medication that you take for your head and just thought I'd mention it to you. It does seem though you're at a very comfortable stage with your medications so I'm glad you seem happy.... Take care and keep posting.
Saw my doctor today.
He is keeping me on Oxycontin. He increased the dose from 30 mg three times a day to 60 mg three times a day. Just in case anyone is in a similar situation, i thought that I would share.
Horselip
He is keeping me on Oxycontin. He increased the dose from 30 mg three times a day to 60 mg three times a day. Just in case anyone is in a similar situation, i thought that I would share.
Horselip
Hi Again NiteByrd-
So then what are you going to do?
Thankfully I am not sick to my stomach from the change. But rather, I feel undermedicated. The one positive is that I do feel that the new formula does last longer which is a good thing if I stay on this med. It just does not feel like the dose is high enough now.
I'm still wanting to hear from others who are in this situation as to whether a dose change or different med is what has worked for you. Thanks
Horselip
So then what are you going to do?
Thankfully I am not sick to my stomach from the change. But rather, I feel undermedicated. The one positive is that I do feel that the new formula does last longer which is a good thing if I stay on this med. It just does not feel like the dose is high enough now.
I'm still wanting to hear from others who are in this situation as to whether a dose change or different med is what has worked for you. Thanks
Horselip
Thank you. No, I did not have a substantial dose change. I contacted my Pharmacist because I got terribly sick and noticed that the new prescription Oxycontin OP looked different from the old Oxycontin OC prescription. The Pharmacist told me that he has received a lot of phone call's from people who have been getting very sick due to the change in the new formula. There have been a lot of patient's hospitalized with congestive heart failure, trouble breathing, etc. He recommended Opana and told me that I should contact my Doctor ( who was not even aware of the new formula change), the manufacturer, Purdue, and the FDA MedWatch.
I hope this information is helpful.
I hope this information is helpful.
Thank you for the info, so to be clear: you had a substantial dose change and your pharmacist recommended Opana?
Thanks
Horselip
Thanks
Horselip
I just want to add that I had no intent to discount anyone's experiences with the OP's. I just wanted to put out there my understanding of one documentable aspect of the change.
I am also a pain patient who has been impacted by needing a significant dose change due to undocumented/unexplained aspects of the reformulation. And my own physician has many patients who have experienced a plethora of widely varying types of problems with the new drug.
And it is, in fact a new drug. It should not be called OxyContin. It is as mechanically different from the drug that has been known as OxyContin for the past 15 years as either drug is to Proladone.
Purdue pulled a huge win with the FDA over this. They waited until just before they were about to lose the ability to sue over patent infringement to submit a carefully worded application for a newly patented drug that would still be called OxyContin.
And they have done so without having to go through the usual prerequisites for a new drug application. The only extensive In Vivo testing was in Rats! There were none of the usual Phase 1, Phase 2, and Phase 3 clinical trials. Instead, an emergency FDA committee met to vote on approval of this new drug to stem the tide of Oxycontin abuse by drug abusers. The vote was not unanimous. The results were: yes: 14, no: 4, and abstain: 1. Many of those who voted yes said that they had done so with regret. Those who did not vote yes gave these reasons:
•MR. YESENKO: I voted no because I'm horrified of the fact that there is no REMS available and the lack of clinical safety presented by the sponsor.
•DR. FLICK: I voted no. I think the company sponsor has done a good job of presenting their product. They did good work. I think they came here in good faith. And I think the new formulation does, indeed, do what they set out to achieve. Unfortunately, by approving this drug, we lose leverage. We no longer can demand -- or at least our ability to demand is less than it was before. We can't have them come back with a REMS or ask them to reduce the dose availability. So I think for that reason, I reluctantly voted no, recognizing that the old formulation would have remained on the market.
•DR. ZITO: I found it difficult to vote yes without conditions, namely improved oversight of benefit, study of benefit, and then around the issue of whether the educational program with given the same name is really going to be effective.
•CHAIRMAN: This is Dr. Kirsch, and I voted no because I felt that, although the data was much better than it was at the previous presentation, I think it's unconscionable to move forward without a well-defined REMS.
•DR. DAY: I abstained because I think there are strong needs of patients for this drug and proper use in prescribing, yet there's incredible risk in other situations, and it got deadlocked for me. And if it had been binary and I was forced to choose, I probably could have narrowed the question more to just is it no worse than the original, and I would have voted yes.
So, the ayes won, and a new drug has been introduced as Oxycontin.
And, oh yes, the anti-abuse measures have been effective. So effective, in fact, that former Oxycontin abusers have switched over to using Heroin. (Most had previously been using OxyContin, even though it was more expensive than heroin, because they always knew what they were getting).
And now, Purdue Pharmaceutical's name can be disassociated from drug abuse, a huge win for the company, although the biggest win is another fifteen years of patent coverage for a drug named OxyContin. I encourageeveryone to call Purdue 1-888-726-7535 and the FDA MedWatch 1-800-332-1088. When I contacted them they seemed very concerned and they were very helpful. My Pharmacist recommended Opana.
I am also a pain patient who has been impacted by needing a significant dose change due to undocumented/unexplained aspects of the reformulation. And my own physician has many patients who have experienced a plethora of widely varying types of problems with the new drug.
And it is, in fact a new drug. It should not be called OxyContin. It is as mechanically different from the drug that has been known as OxyContin for the past 15 years as either drug is to Proladone.
Purdue pulled a huge win with the FDA over this. They waited until just before they were about to lose the ability to sue over patent infringement to submit a carefully worded application for a newly patented drug that would still be called OxyContin.
And they have done so without having to go through the usual prerequisites for a new drug application. The only extensive In Vivo testing was in Rats! There were none of the usual Phase 1, Phase 2, and Phase 3 clinical trials. Instead, an emergency FDA committee met to vote on approval of this new drug to stem the tide of Oxycontin abuse by drug abusers. The vote was not unanimous. The results were: yes: 14, no: 4, and abstain: 1. Many of those who voted yes said that they had done so with regret. Those who did not vote yes gave these reasons:
•MR. YESENKO: I voted no because I'm horrified of the fact that there is no REMS available and the lack of clinical safety presented by the sponsor.
•DR. FLICK: I voted no. I think the company sponsor has done a good job of presenting their product. They did good work. I think they came here in good faith. And I think the new formulation does, indeed, do what they set out to achieve. Unfortunately, by approving this drug, we lose leverage. We no longer can demand -- or at least our ability to demand is less than it was before. We can't have them come back with a REMS or ask them to reduce the dose availability. So I think for that reason, I reluctantly voted no, recognizing that the old formulation would have remained on the market.
•DR. ZITO: I found it difficult to vote yes without conditions, namely improved oversight of benefit, study of benefit, and then around the issue of whether the educational program with given the same name is really going to be effective.
•CHAIRMAN: This is Dr. Kirsch, and I voted no because I felt that, although the data was much better than it was at the previous presentation, I think it's unconscionable to move forward without a well-defined REMS.
•DR. DAY: I abstained because I think there are strong needs of patients for this drug and proper use in prescribing, yet there's incredible risk in other situations, and it got deadlocked for me. And if it had been binary and I was forced to choose, I probably could have narrowed the question more to just is it no worse than the original, and I would have voted yes.
So, the ayes won, and a new drug has been introduced as Oxycontin.
And, oh yes, the anti-abuse measures have been effective. So effective, in fact, that former Oxycontin abusers have switched over to using Heroin. (Most had previously been using OxyContin, even though it was more expensive than heroin, because they always knew what they were getting).
And now, Purdue Pharmaceutical's name can be disassociated from drug abuse, a huge win for the company, although the biggest win is another fifteen years of patent coverage for a drug named OxyContin. I encourageeveryone to call Purdue 1-888-726-7535 and the FDA MedWatch 1-800-332-1088. When I contacted them they seemed very concerned and they were very helpful. My Pharmacist recommended Opana.
If you are accustomed to having to "wait for it to kick in", then there's another problem.
The old formula was documented as being able to last 12 hours per dose, but in fact adequate serum levels were only maintained for about 8 hours. Purdue tried to obscure this in the prescribing package insert by presenting a serum level chart using a logarithmic scale which made it appear that serum levels did not drop significantly for 12 hours, when actually a linear scale would have shown that to be closer to nine hours. It was in fact, really an eight hour medicine, and at q12h, a patient either had to be overprescribed, or had to take a significant amount of breakthrough medicine. Most doctors, upon seeing how their patients responded, wrote scripts for 3 doses per day, to be taken every eight hours. Taking it every eight hours meant that the drug in the next pill started to contribute to your serum level of the drug before the level coming from the previous level dropped enough for you to notice. And (again at eight hour dosing) if you took your breakthrough medicine an hour or two before your regular OC dose, you might even have a brief bump (increase) in serum level instead of a small dip.
The new "OP" formula replaces the old mechanism, which was based primarily upon a combination of ammonio methacrylate copolymer and hypromellose (HPMC), with a new mechanism based primarily upon a combination of PolyOx (tradename for polyethylene oxide, or PEO) and HPMC.
The new mechanism is more easily tuned for longer, more evenly distributed release periods, and a dose that used to be released mostly within the first eight hours is now released evenly over a twelve hour period. This means that you have smaller peaks and troughs, but if you are being underprescribed, you've probably been taking it as a PRN medicine instead of relying on sufficient constant levels of the drug.
If you were getting sufficient constant levels, the concept of OxyContin "kicking in" would be totally alien and meaningless. The only thing you would notice "kicking in" would be the breakthrough medicine when you needed it.
Conceptually, the new OP's are better if they are being prescribed right. Which means both taking into account that each dose contributes to bringing your serum level up to effective levels for a 12 hour period and also that the level it is raised to is only (on average) a little more than 2/3 of the level that an OC had formerly raised it to.
The goal of the prescriber is to provide a continuous effective serum level all month. With OC's you needed to prescribe them every 8 hours, otherwise they became effectively a PRN medication. With OP's you can prescribe them for every 12 hours, but you must take into account that a constant quantity of drug released over 12 hours is necessarily going to produce lower serum levels than the same quantity released at a faster rate over 8 hours.
Just as a side note: The gelling that people complain about is not just an anti-abuse mechanism, but is in itself the dose metering mechanism that produces a constant rate of drug release. You can find documentation on it by googling for "PolyOx".
The old formula was documented as being able to last 12 hours per dose, but in fact adequate serum levels were only maintained for about 8 hours. Purdue tried to obscure this in the prescribing package insert by presenting a serum level chart using a logarithmic scale which made it appear that serum levels did not drop significantly for 12 hours, when actually a linear scale would have shown that to be closer to nine hours. It was in fact, really an eight hour medicine, and at q12h, a patient either had to be overprescribed, or had to take a significant amount of breakthrough medicine. Most doctors, upon seeing how their patients responded, wrote scripts for 3 doses per day, to be taken every eight hours. Taking it every eight hours meant that the drug in the next pill started to contribute to your serum level of the drug before the level coming from the previous level dropped enough for you to notice. And (again at eight hour dosing) if you took your breakthrough medicine an hour or two before your regular OC dose, you might even have a brief bump (increase) in serum level instead of a small dip.
The new "OP" formula replaces the old mechanism, which was based primarily upon a combination of ammonio methacrylate copolymer and hypromellose (HPMC), with a new mechanism based primarily upon a combination of PolyOx (tradename for polyethylene oxide, or PEO) and HPMC.
The new mechanism is more easily tuned for longer, more evenly distributed release periods, and a dose that used to be released mostly within the first eight hours is now released evenly over a twelve hour period. This means that you have smaller peaks and troughs, but if you are being underprescribed, you've probably been taking it as a PRN medicine instead of relying on sufficient constant levels of the drug.
If you were getting sufficient constant levels, the concept of OxyContin "kicking in" would be totally alien and meaningless. The only thing you would notice "kicking in" would be the breakthrough medicine when you needed it.
Conceptually, the new OP's are better if they are being prescribed right. Which means both taking into account that each dose contributes to bringing your serum level up to effective levels for a 12 hour period and also that the level it is raised to is only (on average) a little more than 2/3 of the level that an OC had formerly raised it to.
The goal of the prescriber is to provide a continuous effective serum level all month. With OC's you needed to prescribe them every 8 hours, otherwise they became effectively a PRN medication. With OP's you can prescribe them for every 12 hours, but you must take into account that a constant quantity of drug released over 12 hours is necessarily going to produce lower serum levels than the same quantity released at a faster rate over 8 hours.
Just as a side note: The gelling that people complain about is not just an anti-abuse mechanism, but is in itself the dose metering mechanism that produces a constant rate of drug release. You can find documentation on it by googling for "PolyOx".
Sorry I was having trouble with my computer and pushed the wrong thing. LOL
Anyway, as to your question - there have been several people that have complained about the new formula with the Oxycontin. It doesn't seem to work as well and in some cases it even upsets there stomachs. I don't know it their doctors have been able to do much other than to change them to something diffeent.
Hopefully, there will be some members that are on Oxycontin that can tell you exactly what they did to compensate for the change in the Formula.
Best of luck and PLEASE keep us informed!!!!.....Sherry :)
Anyway, as to your question - there have been several people that have complained about the new formula with the Oxycontin. It doesn't seem to work as well and in some cases it even upsets there stomachs. I don't know it their doctors have been able to do much other than to change them to something diffeent.
Hopefully, there will be some members that are on Oxycontin that can tell you exactly what they did to compensate for the change in the Formula.
Best of luck and PLEASE keep us informed!!!!.....Sherry :)
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