How the reformulation of Oxycontin has affected patients

Having a healthy level of respect for opioids is critical for any physician. For those of us who prescribe or recommend this class of medicines on a daily basis, this statement rings all the more true.Recent events and research reinforce this reality.

“Oxycontin, Other Opioid Painkillers Tied to Higher Health Risks” was the title of a recent BusinessWeek article that references a study in Archives of Internal Medicine about opioid safety in patients with non-cancer pain. In this study, 6300 patients taking one of five analgesics for chronic (non-cancer) pain were followed between 1996-2005.

Rus Portenoy, Chair of Pain Medicine and Palliative Care at Beth Israel Medical Center in NYC and former President of AAHPM responded to the study with caution, recognizing the confounding factors that could influence the data – including clinician knowledge of effective and safe opioid titration rates.

In the same journal, Daniel Solomon and colleagues evaluated the safety of opioids compared with NSAIDS and coxibs in elderly patients with arthritis, and finding that patients on opioids had higher incidence of falls, cardiovascular events, hospitalizations and all-cause mortality.

How the reformulation of Oxycontin has affected patients

The study was released 9 months after Purdue announced its reformulation of Oxycontin, a move made to attempt to prevent abuse. The new formulation makes crushing the pill difficult: instead of turning to a fine powder, it gelatinizes. Despite its release in April, patients have only started to routinely receive this new formulation in the last 6 weeks or so. Since that time, a MedWatch alert has already been released, announcing:

The following events have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet.

Furthermore, alive on the webchats, patients have discussed lack of efficacy of the new formulation, increased side effects – including GI symptoms and new headaches. As a physician prescribing Oxycontin, I have had patients whose breakthrough opioid demand increased dramatically with the change in formulation, with or without the other stated side effects. My approach has been to convert the long-acting oxycodone to another opioid in each case: to methadone or morphine extended release, based on patient’s pain pattern, history of opioid side effects and using principles of opioid conversion.

I wonder whether others of you have had any recent experience with this and how you are addressing the concern.

So far, my experience with these problems has only been related with patients whose Oxycontin requirements were exceptionally high (> 1 g per day). My concern with what I am starting to see is the risk of undertreatment of pain – the potential assumption that patients who have been on higher doses of Oxycontin for a longer period of time might be labeled as “drug seekers” if they suddenly have an increased need for breakthrough pain medication due to lower efficacy of Oxycontin.

Pain and palliative care physicians may be increasingly under the gun to teach our colleagues, make our EDs, oncology and primary care centers aware of this possibility, educate about safe opioid conversion practices, and alert the FDA of observed side effects or change in efficacy through the MedWatch mechanism.

Christian Sinclair is a palliative care physician who blogs at Pallimed.

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  • Smart Doc

    I am not buying the claim that this new Oxycontin is anything less of an extremely dangerous drug.

  • http://allbleedingstops.blogspot.com shadowfax

    Huh. I would suggest that if the decreased efficacy is only evident on the tiny fraction of patients on ENORMOUS doses, then for 99% of people who take this drug the change should be transparent. If it really decreases deaths from overdose and abuse, it’s totally worth the tradeoff. Of course if it just pushes abusers to heroin, then maybe it was more of a mixed blessing.

    Also, seriously? >1g/day of oxys? Wow.

  • ninguem

    What’s the advantage of the new formulation, I’m not clear on this.

    Turning into a gel is irrelevant if someone smokes it. When the drug is abused, at least the patients presenting to my practice, they are either taking PO, or smoking.

    This gel thing does not seem to make a difference. Maybe I’m missing some subtlety.

    It would seem to me, adding naloxone would make a difference. Like in suboxone. Naloxone is not absorbed orally, so a pill taken properly PO would work. Smoke the pill, the naloxone IS absorbed, and the opiate is reversed.

    Maybe I’m missing some detail.

  • M.

    “Pain and palliative care physicians may be increasingly under the gun……”

    I only have one question….isn’t ALL care, PALLIATIVE care?
    Treat, not cure. When was the last thing something was cured?

  • pigulla

    I had more problems with the change in these pills. My pharmacy gave me half of each OC & OP in my bottle and didnt tell me anything about it. Everything went well until I started on the new version of pills and then my body had reactions to the medication(headaches, throwing up, swelling lumps on my head, face, neck and under my armpits, And I started to go threw what the Doctor said was withdraws. In what I was throwing up was a jellyfish looking substance and in that substance under a magnifying lamp anyone could see particles trapped inside this jelly looking mass. I would believe that I really now was having a allergic reation to what was placed in this new formula but now was not getting all of the amount of the drug I was suppose to be recieving. So 2 tablets a day timed released 80 mg (160mg in 24 hour period) I was placed on 30mg IR 4 times a day which because of this great scare doctor had under treated me again. Going from 160mg to 120mg and I did suffer and still do. It only works for 4 1/2 hours to 5 maybe. It would work better at 5 tablets a day, especially since I haven’t had any reaction to these tablets. But since all of this scare, I must put up with pain. For my body less binders are better. But I doe have allergic reactions to many things. Another scare to me is these new pills have not gone threw the research and trials that the OC tablets went threw by the FDA. Its been given a fast pass with our lives in harms way. Another thing I keep reading is that the state of Florida has not passed correct laws or gone under the gun like every other state of our union is going under. And the PIPELINE of drugs still continue as it called. And the Cartels of Mexico have crossed our boarders according to papers and nightly news. Its not going to stop and in the mean time I and others are not being treated because of everything that is happening.

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