Posted in 
Previous: 
: 
10 Things Your Primary Care Doctor Does That Should Make You Run for the Hills
Sign In >>
Dr. Orrange received her BA in Biology at the University of California, San Diego, and a Masters Degree in Health Sciences at the Johns Hopkins University School of Public Health. She received her MD from the USC Keck School of…
FAST FACTS
Advertisement
Will the New OxyContin (OxyContin “OP”) Tablets Prevent Abuse?
”I'd like a doctor's opinion about new Oxycontin "OP": why are real chronic pain patients suffering so much?
I've had RSD for over 11 years and am severely allergic to any other long acting opiate pain reliever. I never got sick on the old formula and now this new one that is to prevent abuse is making me very ill, is less effective in pain control, and I would like to know what doctors opinions are on this subject as true chronic pain patients seem to be the ones who are suffering the most due to this change.”
Every week we read about a comedian, actress, spokesperson or athlete who has overdosed on prescription drugs, often OxyContin. Most of us also know someone who suffers from chronic pain where oral opiates provide the only hope for a pain free life. There is proper use and there is misuse, and nobody can argue with that.
This question from a DS user with chronic pain is a good one: how do physicians feel about the new OxyContin “OP” which may replace previous forms of OxyContin and hopefully make abuse less easy? Well, if this really is a bioequivalent formulation (a drug with the same active properties) I like it.
On April 5, 2010, Purdue Pharma and the FDA announced the approval of a new formulation of OxyContin (controlled-release oxycodone) oral tablets. Purdue elected to change the drug in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse. The reformulated OxyContin is supposed to prevent the medication from being cut, broken, chewed, crushed, or dissolved to release more medication.
OxyContin is such a popular drug of abuse and misuse because of its controlled-release properties; this means each OxyContin tablet contains a large quantity of oxycodone. With the previous formulation you could release high levels of oxycodone all at once, a situation that contributed to a high rate of abuse as well as increased the potential for fatal overdose.
The new formulation (OxyContin OP) has met the FDA criteria for bioequivalence to the original formulation so it should have the same effectiveness and same side effects. Purdue Pharma has started shipping the reformulated OxyContin product and the company will cease shipping the original formulation. So, the previous OxyContin tablets (OxyContin “OC”) will no longer exist.
This was a change made without any evidence. In other words, no evidence currently exists to show that this reformulation of OxyContin is less subject to misuse, abuse, overdose, or addiction. The FDA is requiring Purdue Pharma to conduct a postmarket study to help determine whether the new formulation reduces the drug's abuse and misuse. I would also add that if you are having side effects with this formulation your doctor should report it to Purdue Pharma.
Dr O.
I've had RSD for over 11 years and am severely allergic to any other long acting opiate pain reliever. I never got sick on the old formula and now this new one that is to prevent abuse is making me very ill, is less effective in pain control, and I would like to know what doctors opinions are on this subject as true chronic pain patients seem to be the ones who are suffering the most due to this change.”
Every week we read about a comedian, actress, spokesperson or athlete who has overdosed on prescription drugs, often OxyContin. Most of us also know someone who suffers from chronic pain where oral opiates provide the only hope for a pain free life. There is proper use and there is misuse, and nobody can argue with that.
This question from a DS user with chronic pain is a good one: how do physicians feel about the new OxyContin “OP” which may replace previous forms of OxyContin and hopefully make abuse less easy? Well, if this really is a bioequivalent formulation (a drug with the same active properties) I like it.
On April 5, 2010, Purdue Pharma and the FDA announced the approval of a new formulation of OxyContin (controlled-release oxycodone) oral tablets. Purdue elected to change the drug in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse. The reformulated OxyContin is supposed to prevent the medication from being cut, broken, chewed, crushed, or dissolved to release more medication.
OxyContin is such a popular drug of abuse and misuse because of its controlled-release properties; this means each OxyContin tablet contains a large quantity of oxycodone. With the previous formulation you could release high levels of oxycodone all at once, a situation that contributed to a high rate of abuse as well as increased the potential for fatal overdose.
The new formulation (OxyContin OP) has met the FDA criteria for bioequivalence to the original formulation so it should have the same effectiveness and same side effects. Purdue Pharma has started shipping the reformulated OxyContin product and the company will cease shipping the original formulation. So, the previous OxyContin tablets (OxyContin “OC”) will no longer exist.
This was a change made without any evidence. In other words, no evidence currently exists to show that this reformulation of OxyContin is less subject to misuse, abuse, overdose, or addiction. The FDA is requiring Purdue Pharma to conduct a postmarket study to help determine whether the new formulation reduces the drug's abuse and misuse. I would also add that if you are having side effects with this formulation your doctor should report it to Purdue Pharma.
Dr O.
RELATED SLIDESHOW
Browse through our health and wellness tips. There is something for everyone to enjoy and learn from. Topics include: Parenting, Aging, Exercising, Sleep, Surgery, and more.
View the Slideshow
View the Slideshow
RELATED POSTS
Just wondered how many members on the fibro board take Oxycontin?? Is it good for fibro pain??
Posted on 04/25/08 06:38:25 pm
MORE ARTICLES
CATEGORIES:
Answers
CONDITIONS AND COMMUNITIES:
Back Pain
•
Chronic Pain
•
Cocaine Addiction & Recovery
•
Families & Friends Of Addicts
•
Fibromyalgia
•
Heroin Addiction & Recovery
•
Lupus
•
Medicaid
•
Medical Mysteries
•
Medical Research and Clinical Trials
•
Medicare
•
Myofascial Pain Syndrome
•
Prescription and Synthetic Drug Abuse
•
Reflex Sympathetic Dystrophy
MEMBER COMMENTS
TOTAL COMMENTS: 19
-
View All Comments »
Add a Comment
Displaying comments 19-1 of 19
Got a Question?
POPULAR POSTS
Back Pain
(2,790 Discussion Topics)
(2,790 Discussion Topics)
Chronic Pain
(16,245 Discussion Topics)
(16,245 Discussion Topics)
Cocaine Addiction & Recovery
(1,269 Discussion Topics)
(1,269 Discussion Topics)
Families & Friends Of Addicts
(5,384 Discussion Topics)
(5,384 Discussion Topics)
Fibromyalgia
(34,642 Discussion Topics)
(34,642 Discussion Topics)
Heroin Addiction & Recovery
(723 Discussion Topics)
(723 Discussion Topics)
Lupus
(5,852 Discussion Topics)
(5,852 Discussion Topics)
Medicaid
(54 Discussion Topics)
(54 Discussion Topics)
Medical Mysteries
(157 Discussion Topics)
(157 Discussion Topics)
Medical Research and Clinical Trials
(128 Discussion Topics)
(128 Discussion Topics)
Medicare
(69 Discussion Topics)
(69 Discussion Topics)
Myofascial Pain Syndrome
(1,818 Discussion Topics)
(1,818 Discussion Topics)
Prescription and Synthetic Drug Abuse
(1,489 Discussion Topics)
(1,489 Discussion Topics)
Reflex Sympathetic Dystrophy
(251 Discussion Topics)
(251 Discussion Topics)
While cutting and pasting, I introduced a semantic error in the first sentence of part 3. It should end ''that they have really accomplished it'', not ''that they have really done so''.
I also wish to apologize for my grammatical and spelling errors, before anyone complains about them.
One should be careful when assuming that merely because the manufacturer has represented full bio-equivalence to the FDA, that they have really done so. They have provided a huge amount of paperwork to support that assertion, without proper clinical trials to back it up.
When an FDA committee met to vote on approval of the new formulation, a quarter of the committee members (including the chair) either abstained or voted ''nay'' because they were not satisfied with the data, while many said they voted ''yes'' only because it ''appeared to be no worse than the original'' and ''may impart a minor benefit''. One member stated that he voted yes despite being ''terrified over unintended consequences.
To read the committee meeting minutes, google for UCM187082.pdf
It's 300 pages, so if you just want to read the reasons given for each vote, jump to page 294.
I'd include the URL, but that would bring this over 1024 characters.
Second, please peruse studies 7 and 8, particularly noting the
disparity between adverse effects of patients receiving tablets made at 2 different plants, designated ''Wilson'' and ''Totowa''.
Third, note that despite effective use of the drug being predicated upon achievement of steady state serum levels (a process that takes from 24 to 48 hours of continued dosing to realize) serum levels were evaluated only based upon absorption of the content of lone tablets.
No attempt was made to demonstrate that steady state levels could be achieved as a result of repetitive dosing.
The new ''excipient'', polyethyene oxide, although referred to as an ''inactive ingredient'', is what now controls the rate of drug release, and as such, cannot really be considered ''inactive''.
Polyethylene oxide is a mucoadhesive hydrophilic polymer, with a molecular weight in the millions and having properties that may be compatible with the kind of complaints that have been reported by patients.
Dear Dr. Orrange,
Please read the actual clinical trial reports. I think you may wish to reassess the basis of your assertion about bio-equivalence after you read them.
You can easily find the reports as follows:
Go to clinicaltrials.gov, and enter ''Reformulated Oxycontin'' in the search box. This will bring up links to 8 clinical trial reports. When reading them, please note 3 things.
First please note that all trials were phase 1 studies using only healthy subjects who were required to be opiate naive.
Each subject was given one and only one tablet of each formula spaced a week apart. No evaluation of pain relief took place. This would not have been pssible anyway, because all subjects were required to be healthy and free of pain.
To be continued (1024 limit).
By the way do you know why you are in pain? I do I was poisoned by gadolinium based contrasting agents that are used for MRIs and MRAs and I didn't have kidney disease either. And they continue to use this product and continue to poison the population with this poison. Please become more informed about what is going on. We all suffer when the population is clueless about how corrupt big Pharma is.
On the chronic pain board, under "New Oxycontin OP Q&A ask the expert" on p.2 I cut and pasted an article on the new oxy formulation and other new anti-drug-abuse formulations. The news is from the American Chemical Society, of which I am a member. This is the world's largest society of professional scientists and very credible.
Hi mountainmom, this change in the reformulation has everything to do with Purdue Pharma wanting to make more money off a new product so they can continue to charge the same patent protected charges and gouge their customers. OxyContin is about to lose patent protection which means any pharmaceutical company can sell it and the price drops and the consumer benefits. In order to prevent that from happening they have bought the FDA’s protection made something up. To do this they opportunistically embellished the drug abuse issue while tapping into societal hate of drug abusers. This type of spin has worked so well for decades and we continue to buy into their propaganda. You have no reason to hate drug abusers do you? I wish people would understand what goes on and stop being naïve, sigh.
It wasn't. Two weeks of severe migranes, projectile vomiting and diaherea, extreme pain, the doctor had to take me off of it. She believed it was the same problem with the others, a reaction to something in the filing of the new formula. Until I called her, she didn't even know about the change in formula, or that generic oxycontin was no longer available.
I sure hope that it doesn't work for the druggies and was worth what it is doing to the chronic pain patients lives like mine...
And I speak from experience, they poisoned me. I am about to enter the world known as Nephrogenic Systemic Fibrosis or more appropriately stated Gadolinium Associated Systemic Fibrosis. There is no cure and no treatment. And because this gadolinium based contrasting agent used in MRIs and MRAs has ruined my liver and kidneys I can no longer take their toxic drugs.
Pardon me if I am skeptical about anything they say after so many of us have been poisoned by them with the approval and blessing of the FDA. I did not have renal disease. I was completely healthy.
I have used OxyCodone for years for severe pain. I wish I had kept the label of the old kind. It showed something like "Oxycodone/APAP 5/XXX (a three-digit number that I don't remember.) I think APAP is like Tylenol. The old kind came in a large round pill and I always had to cut it in half because a whole one would give me such a head rush I could hardly stand up - but boy, it took care of the pain!
I recently called my doctor for a refill. I don't ned the stuff very often but I like to have it on hand when I do. The kind he called in is different: Oxycodone 5mg IMM REL." It is in a small round tablet. I can take an entire tablet and not get a head rush, but it doesn't do nearly as much for the pain, either. Just wondered if anybody else knew about this stuff.