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Local families urge FDA to clarify risks in OxyContin reformulation

Original post made on Aug 3, 2010

Don't be fooled by the reformulation of OxyContin and the claims that it is less dangerous than before. That's the message behind the citizen petition to the Federal Drug Administration, which was signed and filed Monday by Danville resident Bob Pack and San Ramon resident April Rovero, as well as two others.

Read the full story here Web Link posted Tuesday, July 20, 2010, 10:17 PM

Comments (9)

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Posted by Groucho
a resident of Blackhawk
on Aug 3, 2010 at 6:06 am

Articles and people like this are going overboard. I cannot imagine the pain you must have gone through losing a child, let alone more. However, Purdue's marketing material is in no way implying that it is abuse resistant, tamper resistant or any other such clap trap. Doctors are asked to write to their medical department for specific answers, but reps cannot address things like they used to. On one hand people are begging for a slight improvement, on the other they are saying that nothing is safe. They are correct, nothing is safe...ever. Why don't you do everyone a favor and stop acting as though there will be a miracle drug and any attempts to get closer to it are not acceptable? THERE WILL NEVER BE AN ABUSE RESISTANT DRUG! EVER! But does that mean companies shouldn't try to get close? And regarding enough people in a test group to show results, that is a catch 22 and if you have the answer, everyone would love to hear it. To see if a clinical trial proves your theories, you spend hundreds of millions of dollars and about 3 - 5 years to run that trial. Now, is everyone saying that the drug should have been delayed by 3 - 5 years so the results could be seen? What happens if someone dies in the meantime that could have been saved had this formulation been available? The post marketing surveillance being done will cover its efficacy and be reported in all upcoming Package Inserts.

So, tell me. If a person dies because they didn't have a drug that may be slightly more deterrent than another, but that drug wasn't available because it still wasn't proven to be a deterrent, would that be acceptable to you?

In my mind there will NEVER be a drug you can't abuse, so to pretend there is and not put out any others who are trying to chase this fictitious unicorn is ridiculous. I have been a doctor for 21 years and still find articles like this shallow and not well thought out. All or nothing medicine has caused the deaths of many people. Things like what happened to your children are unfortunate and should never happen, but the drug didn't cause this. If it wasn't this it would have been something else.

I beg of you, before you start yelling about something do your research. The marketing, promotion and position of Purdue has been an admirable one. And before you look to the FDA for help, remember that the FDA approved this drug and did so enthusiastically. Why? Because it offered a glimmer of hope and they saw that Purdue was saying that it was not the "end all be all". The warning about this drug are in larger print than the add for the drug in every journal I read. No one is getting anything over on anyone. If your doctor gets confused like this and feels that OxyContin doesn't have enough warnings, switch doctors. If you really want to see warnings, look at the release form for the Hepatitis B vaccine some time.

To come to a conclusion, the price has not changed, nor has the formulary coverage. There is no extra money in it for anyone. The FDA had several meeting with Purdue and rightfully said that any help at this point would be good help. So, please. Before you slam a drug that helps millions upon millions each day live a normal life, do some research. Because for you to scare away a patients who needs it due to unwarranted fears makes you worse than anyone.

Dr. Frank Simons
Grand Rapids, MI

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Posted by Deana
a resident of Danville
on Aug 4, 2010 at 2:59 pm

Dr. Simons of Grand Rapids, MI - please clarify your credentials. You are a doctor of what, exactly?

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Posted by Not Fair
a resident of another community
on Aug 7, 2010 at 3:47 pm

If you had as many problems as i do, been through every medication on the market, realized absolutely NONE of them worked for you, and that Oxycontin in general gave me SEVERE stomach pains (allergy? shrug, i donno why) -- then to find out i was taking Generic oxycontin, i was told to try i tried brand (paying an extra $2500/mo cause i cant get brand coverage) i find out that the medication works VERY VERY VERY well on me, but the generic "Footballs" only cause me more pain and suffering in my stomach/bowel (which is the same time release being used in the reformulation, by the research ive done atleast, calling and talking to their pharmacists)

Before i found a medication that worked for me, i wished to end my life, now i find one, been on it for about 5 years, been forced to take the generics randomly within that time (out of stock or to broke to afford my relief) i ran into times with the generics where i couldnt do anything but take care of the opiate withdrawls with the pill and then toss and turn crying with my stomach pain in bed....its fkin redicilous....

so those of us who dont abuse have to suffer, in my case, medications like Dialudid - dont have ANY effect, ive had an injection of over 50mg at a hospital, it did absolutely nothing, no relief, no sedation, nothing, several other medication do barely anything to me, i dont know why but oxycontin (and fentanyl, but to a much lesser extent) are the only 2 medications that work for me......

im frantically trying to find a pharmacist thats willing to stock some of the old brand so atleast i have a few months before i finally kill myself, cause im just tired of all this [edited], its bad enough the [edited] and expenses we have to go through while in pain and suffering, now i have to go into withdrawls OR add a pain to get rid of a different pain, which i allready have stomach/bowel problems so im sure it will be worse than just a pain, for all i know its an allergy and it will cause long term damage to my stomach.....and because i wont have any choice but to take it to stay from the nasty withdrawls at my dose... if im gona be in that pain, i sure hope it causes perm damage, so i can [edited] sue the livin shit out of them for [edited] the only god damn medication thats been released that actually works on me!

i hated life, oxycontin gave me a life back, i was able to move, walk, leave the house, ect, i was still difficult to take care of, hated bothering other people with my problems, but with oxycontin i was able to DO stuff, not just watch or cry about not being able to...and now the rug is being pulled right from under my feet, this is some pure [edited]....

[edited] all you oxy abusers out there, [edited] FDA, [edited] it all - gona go back to hating life and wishing for death, i hope they get seriously sue'd or [edited] over by this reformulation, they deserve it, [edited] charging an arm and a leg for somehting so [edited] cheap wasnt enough, now they have to [edited] up our stomachs too and make random people sick.....

[edited] this god damn country and its FDA....
[edited] the world,
[edited] whatever left me in pain like this from birth
[edited] all of you complaining and ruining oxycontin for those of us who ARE truely suffering....

just [edited] and mind your own god damn business, i leave my death on your hands....for i wont be able to handle it anymore going back to the way i was before i found brand name oxycontin.....

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Posted by Deana
a resident of Danville
on Aug 9, 2010 at 7:58 pm

Not Fair - that truly sounds unbearable. I don't know if this will help at all, but my sister-in-law has gotten around getting some of her meds that are no longer available here by ordering online from Mexico and (I think) Canada.

I hope you find a solution.

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Posted by Jeff
a resident of Vista Grande Elementary School
on Sep 13, 2010 at 1:11 pm

Reformulation? Good for who? A junkie will just find something else. Those of us that get our medication via a prescription are stuck with what's available. So all they have done is to make abusers to go find something else and those of us that had found relief with Oxycontin have lost it. I had finally been able to take a deep breath, it was nice to actually have some relief, now that's gone. My pain doctor told me over 50% of people in severe chronic pain committ suicide. So now they think they are saving lives so people don't OD but for the real people in pain our only out is a bullet.

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Posted by davzway
a resident of another community
on Sep 28, 2010 at 11:08 am

As someone who has had four spine surgeries, two that were deplorable failures making the problem, ie PAIN incredibly worse to the point of not caring whether you live or not, the Oxycontin Brand name by Purdue has been a life saver. A switch to generics by insurance company since they don't WANT to pay higher cost, raises the pain levels back to unacceptable levels (you could offer five 80mg generic tablets or three Brand name 80mg, and I would gladly take the three Brand Name).

Criminals, or those so inclined to abuse a medication, ANYTHING CAN BE ABUSE, you cannot pass a law which will change that. You have tons of laws against heroin and other illegal drugs and it still comes into the country. FDA and government, with lawyers making money at both ends continue their GAMES without any consideration for the people in Pain who need the Brand name Oxycontin medication. After having tried EVERYTHING IN OVER 32 YEARS, the only regimen which works is Brand Name Oxycontin.. Now it changed again.

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Posted by hellonearth
a resident of another community
on Oct 25, 2010 at 1:03 pm

I totally agree/w davzway!D E A!!!F D A!!!!! GOV!!!!unconcerned americans have got to start bieng concerned!The gov has got too much control, We the people who are in too much pain and have our only hope pulled out from under us,are littaray screwed!I've had 8 back surgurys and had!! found relief in oxycontins I'm currently on the new REFORMULATED oxycontins and now SUFFER from extreme headaches,loose bowels(sorry only trying to be honest),and stomache aches!What now,A BULLET MAYBE!I pray somthing good comes out of this for thos of us who abuse drugs,but also pray for those like myself who ar truley in pain!God bless!

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Posted by Ronald Blong
a resident of San Ramon Valley High School
on Dec 27, 2010 at 5:34 am


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Posted by Sherry
a resident of another community
on Mar 12, 2013 at 7:40 am

Iwould like to say the ones who are really suffering are the ones,who truly have pain,and have to get injections that are tainted or just gives relief for a moment but it always comes back,seems to me the people that are complaining are families who suffered a lost family member,for that I understand,maybe this member was getting stuff off the streets,this is just another weapon like guns.this is so unfair for people like myself that has to go to a pain clinic and actually sit with addicts BELEIVE me you can tell who's abusing ,they be right there talking about how to do this with that,and in the long run ,someone like myself who has had over 33 surgeries and has chronic pain has to be hulmiated in front of people,get treated like your no one and this is so wrong,this is what it comes down to.the town I was living in all my meds came from one Dr. And every state is different on laws.I even had a Dr. Tell me take what I give you or go buy your crap off the street.I left there crying.why should I get treated that way.Oh I had just got out off ICU for ten days for a fractured skull,bleeding on frontal lobes a stroke many seizures and 5 broken ribs.Should I have been treated this way.I don't think you would like this said to you.some jump the gun....I had a uncle who said just let me go because I can't take the pain anymore....they make the right meds but give it to the wrong people.or doctors like in Florida who are selling all kinds of meds and they get paid in cash punish them not the patient that needs that one pill a day to move,u need to be in our shoes for just one day before you put us down.......sincerely..........

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