Oxycontin Op New Formula Contact Info

Updated

Hello I am writing in regards to the new OP formula that is making all of us so sick and awful side effects There is a number with the email address to contact these people from purdue pharma. They are not spokesmen but are there to take feedback and complaints. Here are there names and emails to contact them. I got their info from another web site on the new effects people are suffering from there newly formulated Oxycontin pills OP. Good Luck to you all. If we don't say anything or take actions then they will not know or do a thing to fix this MAJOR Problem with this new poison they are distributing to us. Contact call or write to these men if you are having problems with this new medication.

"The new OP (all strengths) will be replacing the regular OC version by the end of 2010. Many people are having problems with this new medication. Here is Purdue's official statement and the reps you can contact with any concerns/complaints, or questions you may have.

James Heins
(203) 588-8069 (office)
(203) 856-2121 (mobile)
email [email protected]

OR

Libby Holman
(203) 856-7670 (office)
(203) 609-1291 (mobile)
email [email protected]

April 5, 2010 - The U.S. Food and Drug Administration (FDA) approved Purdue Pharma L.P.'s New Drug Application for a reformulation of OxyContin ® (oxycodone HCl controlled-release) Tablets.

The reformulation has met FDA criteria for bioequivalence to the original formulation, which means there is no significant difference in the rate and extent of absorption of the therapeutic ingredient.

While similar in appearance to the original formulation, the reformulated tablets have a different marking ("OP") than the currently marketed tablets (marking "OC") and the 60 mg and 80 mg tablets are slightly larger in size than the currently marketed tablets.

Purdue elected to reformulate OxyContin ® to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.

OxyContin ® continues to be a CII controlled substance with all the attendant risks of Schedule II opioids, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as "psychological dependence"). In addition, alteration of the tablet in any manner poses significant risks of overdose and death. The Full Prescribing Information contains warnings about the potential for abuse, diversion, overdose and addiction, including a boxed warning ..."
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1

I suffer from CPS (central pain syndrum) which occured after i suffered a cerebral hemmmorage. The pain is the worst imaginable. when i eas put on oxycontin is was like a miracle drug. My dose was eventually increased to 6 80 mgs a day and the same dose helped me live a tolorable pain level for 10 yrs. I had heard after several years most opiates needed to be increased at least every few years but with OC 80s they were effective for about ten yrs with no need for a higher dose. I was by no means pain free but I was able to live a tolorable existance. when they changed after 2 months I had to try something else 'cause the OPs sucked. The last 6 mos. have been hell and there is no way the OPs are even close. Please bring the old OCs back or at least get it right - I only swallow as directed but the difference is assounding and tough on my system.

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2

MajorPain thanks for providing that information. We have had many posts from people complaining that the new Oxycontin formulation is not as effective, as well as complaints that is causes unusual side effects. It was great of you to provide more contact information to help people report these problems.

In addition to reporting to Purdue Pharma, I also encourage everyone to report the problems to the FDA, so they will take notice of the issue. They can make Purdue change the medication, if enough problems are seen with the new one. Their MedWatch number is:

800-332-1088


Frank, I am very sorry to read of the problems you are having, however, this is an information only website and are not in any way affiliated with any prescription drug manufacturer, therefore, your problem and request will not reach them.

You should follow the advice of the original post for reporting the issue and also report your problem to the FDA at the phone number I have provided.

https:/­/­www.medschat.com/­wiki/­OxyContin/­

Are there any other questions or comments?

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3

I am writing this to help the support of removal of the OP version of OxyContin frrom the market.

I am a mid twenties male who has been relying on OxyContin to work for the last 3 years. Taken as directed and managed to maintain at a very reasonable level of 3x20mg / day. My job is extremely physical so some days are a struggle to not take an extra but I supplement nsaids or breakthrough Vicodin as needed.

However, since they (Purdue) has switched to the new version of OxyContin, I have missed more work than acceptable. While I understand my conditions are worsening, I've not had a problem until October 2010 (when the new formula was merged into my market) with work attendance at all. The new formula does NOT work the same.

I'm not sure what type of clinical trials they used but I feel as though, Purdue's decision (or whoever's) to change the formula for abuse potential problems, is a terrible attempt to correct a problem. As, it has taken away from those of us who NEED these medications to maintain a tolerable life. It has not taken away from the abusers. They have or will figure out a way to abuse them, it's almost insulting. Actually, it IS insulting to me, and I'm sure a lot of you as well.

When I google for this new formula "problems" I see several suggestions in the google box for "how to abuse new formula" etc, so there's plenty of people looking and probably succeeding.

This new formula has caused me a very strange side effect. I have pain in my leg when I take them. I take them for back pain/nerves/spondyissues, so the doctors are generalizing it as sciatica. I spent a day using only my Vicodin, breaking them as dosing them slowly throughout the day to the amount of 40-50mg. I had no leg pain. The pain I refer to feels like poor circulation, as if the OxyContin formulation coagulates in my vein. I can take OxyContin and work/walk/stay on my feet and I experience NO leg pain whatsoever. It is only when I take them and I'm idle.

Ironically, I take less (2x20mg) on 'idle' days, such as weekends, or days where I do not need them but the leg pain worsens the more my leg is active. Again, this has never been an issue until the new formulation.

So, after all this, I am doing a self-detox taper to get myself off of OxyContin and hopefully opiates all together. I have made it to 50% daily intake. It was/is an extremely rough road, considering the less-effectiveness of the new formulation, it is still very good at causing withdrawal symptoms. And, my career HAS to change, because I can physically not do my job without 'something'.



Unfortunately, I have tried every other opiate with minimal or negative success. MSContin, Fentanyl, Darvocet, Codeine, etc etc etc. I discontinued use of each of those because of their side effects and now I will discontinue use of OxyContin, assuming I beat the withdrawal battle, but it's no longer serving me.

I appreciate the info posted and hope a change is made for all current and future chronic pain sufferers.

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Taper2Kick, while we appreciated your post on our site, however, this site does not have anything to do with the manufacturing of any medications.

If you really want your problem to be noticed and try to help make a difference, then you should report your experiences to the FDA and Purdue Pharma.

You can reach them at the following numbers:

Purdue Pharma number for drug safety/medication issues:

888.726.7535


FDA MedWatch number:

800-332-1088

https:/­/­www.medschat.com/­wiki/­OxyContin/­

Are there any other questions or comments?

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5

Taper2Kick, I can certainly relate to many things in your post. I also experienced quite unusual adverse events when supplies changed to OP formula, and I have been telling everyone who will listen including Purdue multiple times as I experienced more and more side effects and the FDA. Its great that Verwon is so diligent in making sure everyone has the info they need to contact those people that might actually be able effect a change rather than people bitching online to each other.

I personally experienced many symptoms I have seen many others reporting such as GI problems (alternating episodes of diaherea and extreme bouts of constipation sometimes experiencing severe episodes of those two polar opposite events within the same 24 hours it was like my body could never stabalize andI felt like I was on a roller coaster) and my GI symptoms continued to increase in intensity while on the OP formula, as I was convinced at first that these symptoms were 'just' side effects that my body would adjust to in a few weeks time...boy was I WRONG! After the Ethex etc "generic" stock dwindled to nothing in my area, I tried for about three and a half months to muscle through the 'side effects' caused by the OP. I DID lose about 25 lbs, which is great but the OP diet was sssoooo not the way to do it! I just could not keep anything doen or in my system for too terribly long so the lbs just 'melted' off albeit in a really really icky manner; my husband started teasing me that I started spending more time in the bathroom than with him, and honestly he was probably not too far off during that time.

Headaches were terrible and never really seemed to altogether go away the whole time I was on OP.

I developed these nasty little ulcers in the mucus membranes located at or near the entrance to my nostrils, around the tear duct area of my eyelids and skin around inner part of eye and eyelids, and most frustrating of all were the ones at the corners of my mouth that would NEVER F-ing HEAL, for basically the whole three months the corners of my mouth were cracked and bleeding. These ulcers all over my face would just not heal and they certainly didn't look or feel like rainbows and kittens!

I began having some mild mental confusion, especially when. First woke up in the morning. Many mornings I woke up in a panic feeling like I had overslept and everyone was going to be so upset with me for missing that important....uh, that important, uh, like thing I was supposed to do, or maybe I was supposed to be somewhere? But for several minutes many mornings I must have jolted myself awake and spent 5 - 10 minutes freaking out because I had such intense feeling that I was really late for something, or missing something vital, or just somehow letting someone down but for several minutes I had absolutely NO IDEA why I felt that way, or what I had forgotten potentially, or on a couple of really confused mornings I honestly could not rember what day of the week it was until I looked it up on the computer and that is a bad feeling, let me tell you! I never forgot my name or who I was or anything like that, and Looking back now I think what was happening was that I must have been really really deeply asleep and was jolted awake abruptly somehow and the disorientation caused anxiety.

And the other obvious symptom many others are reporting was the first indication OP wasn't my OC no mo', was the decreased pain relief. I had been on Oxycontin for most of the last 10 years except for a few short periods where I tried something different either per the doc or insurance issues etc, and like the last poster I had been stable at my dosage for at least three years without additional increases. So it seemed as if the OP either didn't deliver the amount of oxycodone as indicated, or something in the new design prevented me from accessing all the oxycodone in the pill.

Some of the strangest reactions I had included huge systemic, inexplicable hive break outs and an episode of shingles (which I've never had before and I'm in my early 30s).

*** WARNING - if your doc is trying to find a new regimen for you because OP isn't working for you, please beware of Exalgo, a pretty newly released extended release hydromorphone pill because I have read that Exalgo's inactive ingredient's are the same as the OPs and my doc thinks I must be allergic to something in the inactive ingredient list to have these adverse events and with that theory I would do no better with Exalgo. Just something to askyour doc about if you are considering Exalgo. ***

Taper2Kick, I have had pretty miserable last several months trying pretty much most pain meds available to replace the OPs like you too. We tried Opana, hydromorphone, morphine sulphate, Kadian, fentanyl patches and was really running out of options. Thankfully, knock on wood, methadone has worked really well for me. I am not at the same level of functioning as I was before the OP chsnge, but thank god something is finally making a marked improvement and I think the dose just needs to be played with to fine tune it (I had been at a total dose of about 500mg Oxycontin per day and BT oxycodone IR p.r.n up to 120mg stable dose for a few years). So I just wanted to make a possible alternative suggestion if tapering doesn't work out. It is important that your doc is experienced in prescribing methadone for chronic pain because it is a tricky, difficult to convert drug even for the opioid tolerant.

My doc wants me to consider having a spinal cord stimulator trial, but I have reservations because #1 - I already have an intrathcal drug delivery pump implanted which inadvertantly caused more problems, and do I really want MORE hardware in me? and #2 - my husband and I would really like to figure out a feasible way for us to raise children with some of my limitations and a stimulator implant only introduces new things I wouldn't be advised to do because the stim lead could potentially shift position, important restrictions like don't get pregnant and don't lift a toddler...important things to consider if one wants to be a parent. My doc ended up advising me NOT to even consider a stim placement until any children we might have/adopt/fallfrom the sky were about 4 or 5 years old and the necessity of lifting them is much smaller than in their younger years.

Good luck to all suffering adverse reactions to OP, and PLEASE, PLEASE, PLEASE take the time to call the #s Verwon provided for Purdue and the FDA because the OP formula will most definitely NOT change if they don't get legit patient feedback and those are the means set up to report those things so that your experience does get counted and looked at in context.

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