The New Oxycontin With The Imprint Op Compared To The Old Oxycontin With The Old Imprint Oc (Page 2)

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I got my Oxycontin (name brand) today and thought i had gotten the generic because it had OP imprinted on it instead of th regular OC imprinted on it. I ask my phamacist what was going on and he said that Oxycontin had changed their logo. I noticed the pill was slighly bigger so when i took my pill i noticed it give me heartburn really bad just like the generic did when i tried the generic. Now i am in pain, i have the heartburn, and i don't know if i will be able to hold this new formular down because i am so sick at my stomach. Do you think Purdue will ever change the formula of Oxycontin back to the original? I sure hope so. I am going to start a petition to get the old formula back again. Anyone interested in singing it please let me know. Loretta Sloan 630 Bird Road Magnolia, KY 42757.

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21

I have had 4 surgeries and all the nerves in my lower back has been crushed, the only paine med that helps me was oxcy 60, now that they have changed it, it cost more and dose less and cause other problems, such s, headache, heartburn, nausea and very little relief, WHAT do we do now................

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22

Perdue made major changes to a drug that myself and others have taken since 1998 or longer. The origonal formula helped many of us chronic pain sufferers.

Without any warning via the nurse, doctor, pharmacist a Drug called Oxycontin went through major changes and thousands if not millions of prescriptions were given to long time users. The new formulation has made everyone sick in one fashion or the other. The only difference is one side of the pill had the initials OC and after 12 years changed to OP as far as I know the other side remained the same, I did not notice this. It was only after I started getting very ill with stomach cramps, diarhrea head achs and all sorts of strange feelings ranging from wanting to commit suicide to sleeping all day and staying up all night.

At the very least Perdue shoud had sent a letter of change to each pharmacy and or doctor to be posted is an obvious location for x months that wanrned people that took the drug that Oxycontin was being pulled from the market and that Perdue sought and got approval from the FDA to introduce this drug into the public.

Give me a break. I laugh at how impossible Perdue or any drug manufacture could do a major reconstruction of the drug then "slip"it into the publics drink (If you get my analagy) and get away with it.

NO NO NO. Like any drug they should have given the new OP drug a different name, went through the usual 3 pases required to obtain drug approval from the FDA Yet Perdue complately ignored the FDA and or the FDA was in with Perdue to make said changes.

Maybe the People should VS Perdue and the FDA for allowing this major change to the drug without doing appropriate clinical trials.

I would like to know how many people took more of the pills than usual to control their pain and ended up dieing of an overdose because the drug was released from the pill at an unexpected time, say in the middle of the night and certain people have overdosed.

There is a certain obligation that the drug manufactures and the FDA must follow to protect the general public.

I feel (although the intent may have been in the best interest for the abuse factor) that No company has the right to play with human lifes without first giving them some warning that their medication has been completely changed and an explaination of what was done and so forth.

Even that scenario might not hold up in a court of law.

I plea for the attorneys to start posting 1-800-bad-drug style commercials for there are a ton of us people that are ready to sue.

You simply can not do this behind the publics back without some warning.

This reminds me when of when our government injected 12 black men with syphlis drug and allowed them to die knowing that they had injected them with something other than what they had expected.

What drug will be next.

Perdue has nearly lost all of it Medicare payors in Florida. Florida has about 62 Part D drug providers and if you go to Medicare.gov and enter the drug oxycontin you will see few if any companies cover the drug.

Perdue got greedy and recently forced 6 or more other companies that were making generic Oxycodone CR or ER Once a patenet is 15 years old thats it.

Now that Perdue has changed their formula it shouldnt be long until the six companies that were making a cheaper generic resume manufacture of the origonal patenet that now about 18 years old. Perdue can no longer claim no one can copy their OC patenet.

It will be interested to see if others manufactures take over. Perdues GREED with the price has knocked them off almost every list of formulary covered drugs.

Maybe none payed attention but after the generics were being made for $6 retail (80 mg) that Much more Medicare and other insurance companies started covering the 6 non perdue generic drugs.

Perdue with their GREEDY billions got the 6 drug manufactures closed down somehow. I'll never know why unlless someone in the FDA is taking some big kickbacks.

The Oxycodone war has got to be the most outragious war on drugs between drug manufacturesin history.

I Emplore the 6 generic drug manufactures to reintroduce your generic Oxycodone ER and CD (Sameas the Oxycontin OC) with some mild differences.

TEVA did the best. They produced a generic that could not be abused at all. Why would the FDA and Perdue shut down TEVA and keep production of a pill that could be abused on the market???? Figure that one out.

I have no idea of the backdoor politics that went on between Perdue, the FDA and the other 6 generic drug manufactures but eventually this will all come out in the wash.

I don't want to name names but 3 head executives of Perdue have already been hit with Federal drug fines in the millions, some spent time in Prision and we wonder how this could happen to Oxycontin? People I ask you to look sho we are dealing with.

They are nothing but drug lords. What some of you are yet to realize is how important the statement is in the inserts that state tollerance may develope.

What they dont tell you is that when you hit that tollerance mark and it could easily take 20to 30 years that the drug simply and slowly stops working. You think its in your head but as time passes you notice that you must take more and more to obtain the same pain reduction. Before you know it you can no longer control the pain all you know is that you must take the meds everyday just to feel half way normal.

Sure Oxycontin was a God Send in many cases where people only have a few years to live due to cancer but now that I myself have hit this platue or maximum absorbson dose all I can tell you is I never thought I would be facing such a devil in all my life.

Then again a lot of what I am going through might be related to the new formula but I think I hit the max about a year ago. All I can say for sure is this new formulation has sure made gettting use to this NEW DRUG pure hell.

I pray my body will get used to it but I think this drug is going to have to be placed in a class of its own.

In other words, allow reintroduction of the origonal OC drug but teach doctors hw to dispense the drug and make new guidelines on hoiw the drug should be given.

The strange this is Perdue used to mae this drug in the 160 mg form.

When I first started taking Oxycontin in 1998 I took 2 pills in the am and 2 pills in the pm.

Now the average person would assume that 4 pills a day 2 12 hours apart wouldnt be considered a massive dose.

Hell Perdue had me hooked way before they were forced or agreed to take the 160mg off the market.

If the FDA is smart they will force Perdue to place a detox treatment center in every major city and keeps said clinics going unti most people have been haumainly detoxed from this drug so we can find some other drug thats not so addictive to help control our pain.

I feel you would have a 6 to 12 month wiating list at every clinic.

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23

Hey look at the layout of these sites that comeback when keywords OC and OP are used. They are nearly replicas. I thing FDA and PERDUE is monitoring them to judge reactions. By lay they should have changed the name of the drug. There is a 3 phase process. You can just go change a drug and give it to the people and cross your fingers.

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24

To the last poster - we are not sure if this community is actively visited by individuals working for the FDA and/or Purdue ... but what we can say is that this site is owned and operated independent of those organizations. Hope this helps to clear some things up...

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25

I dont think these new oxcys are as good as the older ones. They give you heartburn and do NOT take the pain away like the old ones, They make me very sick to my stomach as well. I have even tried to take two pills at onceand there still not as good as one of the old ones.I have even started to get Headaches and i haven had headaches in a very long time.
I would be glad to sign a petition if it got started///////////

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26

I also think that we should not bbuying the new oxcys, this would make purdue lose one hell of a lot of money and that would force them to do something different. If people are stupid enough to take these pills in a way that they shouldnt, then to heck with them, why PUNISH us. Let stick together on this and see how long it takes for purdue to change.

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27

I was a state worker for 14 yrs a PUBLIC SERVANT. I was severely injured while performing my duties and ended up with 3 neck surgeries and at 37 yrs old was forced to retire. The only med that helps me get out of bed due to severe swelling everyday is oxycontin. I also noticed side-effects of the new product OP. Heartburn, headaches, and sick to my stomach. At first i thought i had the flu because despite my neck injeries I have never had any of these other problems. Now I'm told because of drug addits who like to snort, shoot or whatever else with this drug the rest of us that depend on it to get out of our beds and function are forced to take these new plastic pills that do not last and take forever to kick in. FYI druggies always have done this to any drug they can get. Do the pharmacy goo roos think this has changed. Thanks for putting us all in the same catagory, i for one recent this and am suffering. The OC oxy was the only pain reliever that was giving me quality life. and FYI-druggies will always find a way around it anyway. please change it back or go case by case at least.

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28

Misty Said: All you need is a Pedi-paw and grind them up (powders up better than the old OC's!) and snort!!!!

After reading this, does anyone wonder any more why they changed it?

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29

Taken off of a Purdue Company Board:

The clinical trials that were performed are available for all to see, much to the FDA's chagrin. Please go to clinicaltrials.gov and enter "reformulated oxycontin" in the search box.

If you can call them clinical trials, that is. They were all open label. No blinding was done, whatsoever. Only phase 1 trials were performed.

All study subjects were healthy volunteers with no medical problems, and all were opiate naive. Pain relief was not assessed (The subjects did not have pain that needed to be relieved).

In all studies the method was the same. Except when comparin manufacturing plants (studies 7 and 8), "test" referred to the new formula, and "reference" referred to the old formula.

In each study the subjects were divided into two groups. In group A, subjects were given one tablet of the reference drug, and then a week later they were given one tablet of the test drug. In group B, the order was reversed: subjects were given one tablet of the test drug, and then a week later they were given one tablet of the reference drug.

In tests 7 and 8, tablets made in the Wilson Plant were labeled "reference", and tablets made int the Totowa plant were labeled "test".

Study 7 compared 80 mg tablets made in two plants, "Wilson" and "Totowa".

At high opioid levels (a single 80 mg dose contains the oxycodone content of sixteen percocet tablets) where all of the (opiate naive) subjects would be expected to experience adverse events, a statistically significant number of subjects receiving tablets made at the Wilson plant did not experience any adverse events, while all subjects receiving tablets made at the Totowa plant experienced adverse events, as would be expected.

Study 8 was similar to study 7, except that subjects were given 10 mg tablets instead of 80 mg tablets. In this study 50% more subjects experienced adverse effects with pills made in Totowa than in Wilson. Statistically speaking, this is huge.

Taken together, the results of both studies would tend to indicate that the Wilson plant was not producing tablets that functioned as they would be expected to function when administered to opioid naive patients.

The remainder of the studies compared old and new versions of 80, 40, and 10 mg tablets. It is unknown which plants manufactured the tablets used in any of these studies. In some studies the tablets were given to fasting subjects, and in in others, to fed subjects, In most of the studies, there were more adverse events with the new formula than with the old.

Here are the adverse event numbers (I hope that this board does not mess with the columns)

(study / dose / fed or fasting)

1. 40 mg Fed: 88 / 35 / 22 (subjects/new / old )

2. 40 mg Fast: 92 / 30 / 32 (subjects/new / old )

3. 80 mg Fed: 79 / 53 / 43 (subjects/new / old )

4. 10 mg Fast: 84 / 23 / 14 (subjects/new / old )

5. 10 mg Fed: 85 / 41 / 29 (subjects/new / old )

6. 80 mg Fast: 84 / 47 / 69 (subjects/new / old )

In 4 of the 6 studies, subjects given the new formulation tablets had more adverse events than those given the old formulation. This included all studies where the subjects had been fed and the 10 mg fasting study. While this tends to show a trend, the studies are uncontrolled, and we don't even know how the results may have been influenced by which plant the test tablets were manufactured in (see discussion of tests 7 and 8).

As far as calling the FDA, I did so months ago, at the urging of my doctor, who told me that the majority of those patients he had been prescribing oxycontin to were were experiencing problems of one sort or another. He said that I was one of the lucky ones who haven't been experiencing worse problems, but should call anyway.

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30

Also taken from the "Company Boards/Purdue" section of the same Pharmaceutical forum, this one was actually posted prior to the other one. This one, written before it's author had read all of the studies in detail, just elaborates on studies 7 and 8:

Please examine the reformulated Oxycontin trial results at clinicalaltrials.gov, particularly:

The basis of these studies is questionable, as the drug is specifically not intended to be taken on a PRN basis, yet the study patients were given no more than one tablet each per week.

While the basis is questionable, how the results made it past FDA scrutiny is probably a matter for the courts.

These were 2 studies (one for 10 mg pills, and one for 80 mg pills) performed to determine whether pills manufactured at 2 different plants were bioequivalent to *each other*.

The drug used for one study was reformulated Oxycontin 10 mg. Over a twelve hour period this is roughly equivalent to the amount of Oxycodone in one percocet tablet, plus the amount of oxycodone in a second percocet tablet taken 6 hours later, for a total amount of oxycodone equivalent to that found in two percocet tablets.

For the other study, it was reformulated Oxycontin 80 mg. Over a twelve hour period this is iroughly equivalent to the oxycodone in eight (8) percocet tablets, plus the amount of oxycodone in an additional eight (8) percocet tablets taken 6 hours later, for a total amount of oxycodone equivalent to that found in sixteen percocet tablets.

In one study, there were 22 females and 36 males among which the number of participants affected by adverse events from taking 80 mg pills made in Totowa was 58 and the number of participants affected by adverse events from taking 80 mg pills made in Wilson (North Carolina) was 48.

I think it would be highly unlikely for an opioid naive patient who was actually administered an 80 mg tablet to not experience any adverse effects whatsoever. Remember, this is the equivalent of sixteen percocet tablets!

For 10 patients taking 80 mg tablets made in one plant to experience no adverse events whatsoever, either (A) most or all of these 10 misrepresented themselves as being opioid naive when they were not, or (B) the tablets did not truly contain 80 mg, or (C) something was interfering with the absorption of API from tablets made at that plant. Unless the patients had been untruthful, it is likely that there was some kind of problem in the manufacturing process at that plant.

Either the study was tainted, or the study caught a manufacturing defect to which no attention had been paid. In either case, an investigation should have been initiated.

In the 10mg tablet study, there were 26 females and 29 males among which the number of participants affected by adverse events from taking 10 mg pills made in Totowa was 25 while the number of participants affected by adverse events from taking 10 mg pills made in Wilson (NC) was 17.

The 10mg study is as interesting as the 80 mg study in that it is both the case in the 10 mg study that a sizable portion of participants did not have adverse events, and the case that the number of patients reporting adverse events for pills made in Totowa was 50% higher than for pills made in Wilson.

Given that two studies were performed at dosage extremes, some comparative analysis can be done.

At high opioid levels (a single 80 mg dose containing the oxycodone content of sixteen percocets) where all patients were likely to experience adverse events, a statistically significant number of patients receiving tablets made at the Wilson plant did not experience any adverse events.

Second, at the relatively low level of 10 mg for a 12 hour dose, 50% more patients experienced adverse effects with pills made in Totowa than in Wilson. Statistically speaking, this is huge. Taken together, the results of both studies would tend to indicate that the Wilson plant is not producing tablets that function as they are specified to function.

This may account for conflicting reports from the field, where some patients achieve adequate pain control, while many do not and some patients experience adverse events that imply withdrawal.

I think that some people are receiving tablets made in the Wilson plant, and these are the people for whom the new formula does not provide pain relief, while others are receiving tablets made in the Totowa plant, and so are getting pain relief.

A separate issue that I've only glossed over is that while the drugs are intended for continuous, non-stop use, the only testing done used methodology more appropriate to PRN pain medication. No provision was made for evaluating the possibility of the drug failing to be biocompatible with the original formula in long-term usage.

At best, patients receiving the newly formulated drugs are effectively part of a hugely multi-central clinical trial of the drug's effectiveness and safety when used as intended. Or in other words, Oxycontin patients are serving as uncompensated Human Guinea Pigs.

------------------

Not having to do with the results of those two studies, a consideration I have not read discussed anywhere else, (that may be a non sequitur, but then again, may not) is of whether the new formulation might affect the absorption of other drugs differently than the old formula did. The new formula uses polyethylene oxide, which provides for limitation of drug absorption in several ways including diffusion through the gel. The gel itself reportedly has a high affinity for mucous tissue, such as the mucosa of the small and large intestines where foods, drugs, and water are absorbed. If the particular gel matrix used were to move through the intestinal tract by sliding across the intestinal mucosa, how might it delay or prevent absorption of other drugs at their intended absorption points within the intestinal tract?

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31

[QUOTE who=Loretta] Loretta Sloan wrote: Anyone interested in singing it please let me know. Loretta [/QUOTE]

I'm not sure, Loretta. Could you hum a few bars?

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32

I used to get migraines and thought they were just back again. Now looking back to when they started again it was when the op came out. The last two months taking them I've also had chest pain heartburn and massive headaches w vomiting. My pain level has shot up through the roof. I need to be able to function I need a job before I lose my car and my house, I would love to play w my three grandbabies, I can't even pick them up they are all under six mos old, and my relationship is falling apart he says I can't even touch you anymore and you sleep w a pillow between us. Thanks perdu I would like to know what we are supposed to do to get out of pain go back to the original. The drug addicts will find ways to abuse it anyway. They already have. They can abuse sugar for God sakes so why punish us.

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33

Ill sign it too

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34

Much more effective than a petition will be lots of individual letters to your Senators and congressperson.

Good advice on writing such a letter can be found at: http:/­/­www.inthefaceofpain.com/­show.aspx?name=26

Avoid speculation as to why the reformulated drug no longer works and/or is causing side effects that were not previously experienced.

Just describe your experience. The pattern that they see will be way more important than your speculation as to the mechanism involved.

Ironically, the site is sponsored by Purdue.

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35

Hi Loretta, you can count me in as well. It is Dec.12, 2010, I have been on the new medication for about a week and have not been able to get a good nights rest because of the pain and now added stomach problems. I also have noticed a hot sensation on the back of my head. I'm in tears from pain and frustration, how could they do this to us? Why should we have to suffer because there are idiots in this world? They obviously are selfish people who only care about getting high (we all have choices to make), if they want to abuse them, they are going to NO MATTER WHAT. I have taken the Oxycontin OC's the way they are prescribed and never have had bad side effects (but constipation). This drug has given me a decent quality of life, not the best but decent. Now chronic pain patients are the only ones suffering (the druggies will just find another high or a way around it). Purdue shame on you, you have to know that this new formulation isn't good for us chronic pain patients. You gave us our life back and now have just about killed us. we can't live like this. Please bring back the original.

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36

the new OP pills are giving me upset stomach and I throwup my other medication.

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37

my urine has also been smelling like amonia.

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38

ive been on oxycontin oc for 6 months now i have DDD (degenerative disk disease) lyme disease, wich makes your joints hurt uncontrolably and arthrites... the 60mg oc i was taking was working just fine... two month ago i noticed they switched them and taking these new ones do not work near as well.. im finding i somtimes have to take 1 more than i am prescribed to get the relief i am in need of. i cant do the things i once did and it really bothers me.. i pray that the old ones the oxycontin oc will come back to the market its hard to live with this pain. not to mention im having alot harder of a time going to the bathroom and heart burn on occastion.. so please if any one has control of helping please do so... thank you

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39

I called Purdu and they told me they STOPPED MAKING THEM AND THEY WILL NEVER MAKE THEM AGAIN. SOME ONE SAID IF IT HAD OP INSTEAD OF OC ON IT, THE MEDICINE IS STILL THE OLD OXYCONTIN, I DONT KNOW IF IT IS OR NOT. SOME ONE ELSE SAID SHE CALLED THEM AND THEY ARE SENDING HER A FORM TO GIVE TO HER DOCTOR AND IF HE ADDED THE OP TO THE SCRIPT AND FILLED THIS PAPER OUT SHE WOULD GET THE OLD ONE'S. I DO NOT BELEIVE WHAT IS GOING ON, BUT LET'S LET AND SELL TO PEOPLE GO GET DRUNK WHICH IS LEGAL, BUT IT IS THEIR CHOICE TO DRINK AND DRIVE AND KILL A WHOLE FAMILY GOING TO THE STORE, BUT PEOPLE THAT NEED LEGAL MEDICINE THAT WORK'S FOR THEM THEY ARE NOT ALLOWED TO HAVE THAT. THIS IS SO SCREWED UP IT IS NOT EVEN FUNNY. WHAT DO PEOPLE THINK WE ARE SUPPOSE TO DO AND I HAVE NEVER ABUSED ANY THING IN MY LIFE. THIS IS JUST NOT FAIR.

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40

Its not about helping us anymore. The government wants the old Oxy off the market for good and if we suffer thats just too bad. Until they suffer the same pain we have now it wont change. I can only see it getting worse and to the point that Dr's will not write for any pain pill for chronic pain. Its all in our heads right ? We can thank our government not purdue for this change.

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