Vicodin and Percocet banned and taken off the market, or is a black box warning more likely?

The FDA has declared war on acetaminophen, with Vicodin and Percocet being collateral damage.  You can bet Dr. Gregory House is sweatin’ pretty hard over this news.

Vicodin and Percocet banned and taken off the market, or is a black box warning more likely? In the last few days, acetaminophen, otherwise known as the brand name Tylenol, has been squarely in the FDA advisory panel’s crosshairs. In general, it’s a very safe medication, but there is concern about liver damage in high doses.

Vicodin and Percocet combines acetaminophen with a short acting narcotic, and is a favorite among those who divert drugs.  There is a high potential for dependency.  I’m predicting their street value is pretty much exploding as I type this.

In a 20-17 vote, the advisory panel determined that they should be pulled off the market entirely, which is big news considering they are among the most widely used drugs in the United States. In a separate vote, the panel, at minimum, wants a black box warning on these drugs if they remain.

There is going to be huge opposition to this, mainly from pain management specialists who use both Percocet and Vicodin for controlling “breakthrough” pain. It’s likely that oxycodone, Percocet without the acetaminophen component, will skyrocket in use.

In another vote, the maximum dose of acetaminophen, typically 4 grams per day, will be lowered. Of course, the panel didn’t give what the new maximum would be, so that’s really not helpful information for practicing doctors.

And furthermore, expect that the one gram dose of Tylenol to be only available via prescription.

I find it somewhat odd that so much attention is focused on acetaminophen, since it’s one of the safer drugs out there. In fact, although I don’t readily have the data, NSAIDs like Aleve, Motrin or Advil, along with aspirin, probably are more dangerous drugs because of their bleeding risk and potential to cause ulcers.

If I were the makers of those medications, I wouldn’t be resting too easy. They could be next.

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  • http://idlaurenn.tumblr.com Lauren

    Crap. I guess I’ll have to resort back to controlled morphine.

  • Brian

    Maybe this is in response to MJ’s painkiller addiction?

  • Kim

    Hmm. What other options are available to doctors for, say, the outpatient surgery patient? In a handful of sports injuries and related surgeries, vicodin is the only prescription pain medicine I’ve ever received.

  • http://thejobbingdoctor.blogspot.com thejobbingdoctor

    As a practising British primary Care doctor (GP) we found that one of this type of drug used in the UK was very valuable for back pain, but had a higher risk of successful suicide if combined with alcohol: this was a combination of Acetamidophen (Paracetamol in the UK) and Dextrpopoxyphene (short acting moderate opiate).

    It was withdrawn from use in the UK around 5 years ago, and the rate of suicide has dropped. I wouldn’t be at all surprised if the US authorities followed suit.

  • http://www.pankajkaranmd.blogspot.com Pankaj Karan,MD

    It is just ridiculous that FDA is being reactive rather than being proactive about how to help doctors in controlling prescription of pain medications.
    Here are some of my suggestions:
    1. FDA in concert with DEA should allow doctors to have realtime data on patient to see who is getting narcotic meds from multiple doctors so that prescribe can take action.At present,prescriber has to filla form and send it to DEA office to get “Patient Activity Report” which is usually 3-4 months behind in its data collection.At lease by looking at it you can tell if pt has received narcotic meds from other provider and then when and how much. This is what I do and has been very helpful.
    2. A general guidelines and CME requirement for all providers who prescribe pain management.
    3. On going education for patients about addiction
    4.Intervention and referral for pain management or chemical dependancy specialists.

  • http://somebodyhealme.dianalee.net Diana Lee

    Considering that these drugs are safe when used as directed and that the vast majority of overdoses are suicide attempts, I find this recommendation completely ludicrous.

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  • Andrew

    This is from the organization that brought us the war on Cheerios, while hundreds of potentially life-changing drugs languish in approval limbo and script abuse runs rampant among young adults. But those are all trivial matters when compared to the white threat: Tylenol!

    Anything to keep the FDA in the spotlight, otherwise the public might think that they are, heavens forbid, useless.

  • ray

    NO matter how we look at it, U.S is the leader in pain killer med usage in the world. I personally feel NSAIDs- motrin, aleve, ibuprofen, advil are more dangerous to be sold as over the counter and should be addressed first. They cause kidney failures, bleeding and if patients start using them more then we will see spike in GI and kidney complications.

  • http://content.healthaffairs.org feminizedwesternmale

    Get used to it folks; our federal overlords have been given the green light to rule upon every aspect of our lives and professions.
    People should stop being surprised and start asking why.
    It isn’t about safety. It isn’t about cost. It isn’t about better health.
    It is about power and the modern bureaucratic state, where appearance is more important than performance and the size of the process (and all that stay employed) has become more important than the original purpose.

    There’s safety (and deflected responsibility) in numbers!

  • http://theviewfromher.blogspot.com rositta

    Safe is used as directed…that’s the key isn’t it. I have used percocet for over 40 years at a rate of maybe ONE pill a month for migraine. During two recent surgeries, hip replacement and foot reconstruction, I was given percocent to be taken 2 every 4 hours for pain. I spent two days puking my guts out before giving up those pills and resorting to just Ibuprofen at the lowest dosage. I suppose that some people shouldn’t take these drugs and I also suppose that addiction is possible. It’s not an issue for me but just the fact that these drugs made me vomit is enough to never take them again in large dosage. I will of course still have to take one for migraine but I doubt that one pill will create an issue. This is all in reaction to the MJ death isn’t it?

  • Brandon Shepherd

    So, the FDA would rather give Morphine to patients with chronic pain? Which is even MORE addicting than Vicodin OR Percocet? And the people who are currently taking these pain medications are likely going to suffer anyways, from horrible withdrawal, because the FDA has refused their use…

  • http://that-xmas.livejournal.com/ Xmas

    Isn’t this the sort of problem that Vioxx and other COX-2 inhibitors were supposed to solve?

  • SIllIMMD

    It’s a good idea that more people know about risks of over the counter meds like acetaminophen. It seems a bit of overreaction to pull products off the market though.

    p.s. From my experience, NSAIDs and aspirin have done a lot more damage.

  • Anonymous

    Seems like doctors prescribe Vicodin (hydrocodone + acetaminophen) like candy these days, even for cases where it is unlikely to be needed (e.g. tooth extractions). Perhaps just a symptom of a “throw drugs at the problem” attitude that many doctors and patients seem to have.

    Another symptom of that is the common use of aspirin, NSAIDs, and acetaminophen to lower a mild fever. Why not just let the fever burn (as long as it does not get to dangerous levels) to kill off the infection faster, instead of suppressing the fever (part of the body’s defense against infection) and prolonging the sickness?

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  • Felisha

    well thats just gonna cause people to resort to drastic measures who are addicted for pain relief and that will resort to methadone, crack, cocoain, meth, and any other form of narcotic to get their mind off of the pain .. I was taking vicodin for 12 yrs and before dr’s could do anything for my pain i was resorting to achohol, cocaine, any drug that would usually numb my mind from the pain of Multiple sclorosis, I never liked weed… I have found a great doctor now and he has controlled my pain with a time released pain med that is fairly new to the market.. but I am the thype of person I never drink anything or do drugs but to get pain relief I forced myself to do it… I am no longer taking anything but my reg time released pain med. not even vicodin. but in the past I had to resort to the streets to buy my meds, because doctors worrying about their license rather than thier patients being comfortable and having an active life and enjoyng my time with my kids while i still can!

  • kellie

    After 3 knee unsuccesful knee sugeries my ortho has diagnosed my knee pain as a genetic disorder (patella/femeral disfunction). The patella cartilage is breaking down and wearing away (both knees). At 35 yrs old I am too young for total knee replacements as there is nothing that can be done to stop this. I am prescribed percocet (3 times/day) just to live a functioning lifestyle and enjoy normal activities with my family. What will I do now? Stay in bed for the next 5 years until I get replacements? Frustrating!

  • Pam W

    In 1997 I had a car accident that shattered my spinal column and I had a mild spinal cord injury. Chronic pain, especially in the winter is horrible, even with pain meds. Now I hear I won’t be able to have them. What am I to do? Sit and vegitate?? Lose all that flexibility that I have?? Lose all the muscle tone I have?? Sorry, I have a problem with all this. I only take it when I absolutly have to, but I feel I am being punished once again for getting hurt on the job. (not really but it seems like that) It’s not fair that celebs abuse drugs and we have to suffer THEIR consequences!!!!!!!!!!!!!!

  • http://somebodyhealme.dianalee.net Diana Lee

    Serious question: If these products are available without acetaminophen, which is what causes the liver damage if overused, why aren’t the other versions prescribed instead?

  • Cheryl Janney

    I am seriously ticked off. I have a herniated disc again in my neck which I will need surgery. VIcodin is the only pain killer that somewhat helps. Percocet did nothing for me and I know OTC painkillers do not work. The pain is so bad that I can’t do anything without taking 2 at one time once a day at night. I need to function for my 8 month old son. I can’t wait to have surgery because it helped the last time but I need to get by until then.

  • Melissa

    I take Vicodin regularly for my chronic pain and my doctor checks my liver enzymes consistently. It would be absolutely absurd to even consider removing these drugs from the market. And to replace them with drugs which are probably more addictive and damaging is even more absurd. I don’t know who the people are that sit on this “Panel”, but, they really need to get a grip. And not that I wish my pain on anyone, but, if they had to deal with my pain without the medications they would have never voted to have these medications removed from the market. If you must do anything at all then go with the label. But, really, to force people like me to take even more damaging drugs is positively the most ridiculous thing I’ve ever heard. Have your liver and other bloodwork monitored regularly by your physician and you’ll be fine. Don’t blame the drug!!!

  • Felisha

    they should take away achohol the most dangerous and biggest drug that kills on a daily basis … innocent people who dont even drink or use drugs .. or how about tylenol alone causes liver damage .. or too much excedrin causes a heat attack… these people need to f*ckin open thier eyes and maybe stop the # 1 killer of people and that is achohol .. use your brains!!!

  • http://drgrumpyinthehouse.blogspot.com Dr. Grumpy

    I have no problem with minimizing the APAP content to 325mg per pill, but hope tthey don’t toss these all together.

  • Kenny

    Wow, this is quite possibly the most stupid thing I have ever heard of. I’m only 23 years old, I don’t even know what is wrong with my back because in this wonderful country I don’t have insurance so I’m pushed to the bottom of the list and I have been in insufferable pain for the last 7 months as a result. After waiting for 6 1/2 months, I was finally prescribed Vicodin, and I was at least able to function due to the efforts of those who love me and the drug, and now I come to find out that due to some sick ****, I have to be in pain, AGAIN!? This is absolute rederick.

  • http://kevinmd.com jennifer d

    What I don’t understand why people take prescription pain pills to begin with. Four years ago I got a sinus infection that went to my ears. I was in excruciating pain and my doctor insisted on giving me Vicodin. I too ONLY one and fell asleep in the middle of the afternoon writing an email. Is it really worth it to get out of pain. My poain went away a week later.

  • The Arm Bar Kid

    Kellie, count yourself lucky that your doctor is willing to even treat your PFPS. I’m 33 and my ortho gave up on me when physical therapy didn’t work. Told me to (ironically) “Take some Tylenol if it hurts so damn bad.” I’ve run into that a LOT here in Iowa. Pain clinics in central Iowa won’t treat any condition that can’t be fixed with a needle to the spine.

  • SIIIIMMD

    There are some (quite strident) people who have posted here who are unwitting evidence of why narcotics for chronic nonmalignant pain is such a worrisome practice and who sound a lot like “drug seekers” that I have had to fire from my practice. However, this is not to say that narcs don’t have a role. But the original issue here was the dangers of acetaminophen, not the opiates.

  • Pam

    Why do I take NON-NARCOTIC pain meds? Lets see..Car accident where my spinal column shattered into a million pieces and I almost died leaving me with a spinal cord injury. Am fortunate to be alive and to be walking. I have had 12, yes 12 surgeries to attempt to make me better. I have over $58,000 worth of hardware in my back alone. In 2001 they took a mallet and REBROKE my back and reset it. In the winter I can hardly move due to the pain and stiffness. When the wind hits me just right, I can feel the hardware, even thru a coat and clothes. When the temps drop drastically, I sit in my chair because I stiffen up and cannot move. When we have a cold rain, I have pain and I ache. I tell you what…you spend one day in my body and see how long you last!!!!!! Throw in the fibromyalgia, arachnoid..and everything else associated with this injury..So don’t you tell me there is no reason for me not to take any pain meds. I do keep my weight off, I do try to keep active every day, I do go to a therapy pool where the water is 90 degrees, but don’t tell me there is no reason for me to need some type of pain releif.

  • The Arm Bar Kid

    Jennifer, I’m glad your sinus infection went away. I’ve been in pain since my botched tibial tubercle revision in 2000! Live in constant pain for 9+ years, then get back to me bout why people want pain relief.

    I just want relief, period. I don’t care if it comes in the form of shaking chicken bones over my forehead…if that’s what works, so be it. If it has to come in pill form, so be it.

    Our issue here is that taking Vicodin and Percocet off the market is going to make pain relief for a LOT of patients impossible. Let’s face it, most doctors simply aren’t going to simply switch to CII’s for their pain patients. They’ll just start ignoring their patients’ pain…the way doctors around central Iowa ignore the pain of most patients.

  • Doctor Rocktor

    Strangely enough, “Percocet” (Endocet, and its generic equivalents) *already* limit the acetaminophen content per 5 mg oxycodone tablet to only 325 mg (not 500 mg) …

    … Whereas Vicodin (and its generics equivalents) are the products that include 500 mg of acetaminophen per 5 mg tablet of hydrocodone).

    Such patent technical “tone-deafness” on the part of the FDA panel seems non-accidental ( arising out of political image making activities, rather than common sense).

    For patients consuming more than eight (8) of such hydrocodne doses daily, it would make good sense (and would not be problematic at all for the manufacturers) to provide hydrocodone (only), in the manner that oxycodone has been provided for some time already.

    That’s fine. The rest appears absurd and misplaced.
    .

  • PimpLimp

    I am perscribed percocet 10s for a bad knee, I wonder if my doc will up me to roxys? When are the perks gonna become unavailable?

  • Doctor Rocktor

    A couple of reports in the press state that *nothing* would happen for (likely) several months from now, when the geniuses at the FDA may/will conduct another vote on the matter that would (only at that time, if it occurs) be binding.

    Good luck finding any info about this whatsoever on the FDA’s web-site. I could find nothing. However, if one digs deep enough into their “rule-making” processes, it might be possible to get some information (albeit semi-incoherent) out of the Delphic oracle.
    .

  • Jef

    The docs on here are idiots and don’t want to understand others pain. You should not have went into practice if you dont want to help people. These MD’s need to go into a different profession such as business or something where there ignorance will come in handy!

  • Doctor Rocktor

    AN (EFFECTIVE) “RE-SCHEDULING” OF HYDROCODONE BY THE FDA GOING ON?

    (If) the information below is indeed true (any experts out there to verify this information?), then elimination of Hydrocodone complexed with Acetaminophen would (effectively) place the (then only available) Hydrocodone *only* formulations under Schedule II controls, as opposed to (what this excerpt from the article states is) Schedule III controls. Who would have thunk it? No other members of the press found so far, as far as I can see.

    “When combined with Tylenol, hydrocodone is a Schedule III drug (the same thing goes for codeine, but not, oddly, for oxycodone, which is Schedule II whether or not it comes with Tylenol. That phrasing, with the comma-oddly-comma, tends to apply to a great number of things the DEA does. We hope to go into this in more detail soon. Journalisticness-ier!). Schedule III drugs just need a prescription and can be refilled by mail, in three-month quantities, all that good stuff. Hydrocodone alone, however, is a Schedule II drug, meaning prescriptions can’t be for more than a month, all prescriptions must be written and verified, and the physician must be registered with the DEA and file reports and generally do a lot of things that involve suspecting the patient instead of treating them.”

    http://www.alternet.org/drugreporter/141244/blame_it_on_the_tylenol_behind_the_govt.%27s_idea_to_pull_vicodin_and_percoset_from_the_shelves/?page=2

    If true, the (largely) “unseen hands” at work here may have been revealed. It’s certainly easier to (effectively) “re-schedule” a molecule via such a proposed FDA Regulatory change than it would be to convince Congress to amend the Controlled Substances Act. Very interesting.

    I am finding further confirmation in the press that the final decision on the part of the FDA will likely be several months in the future. One wonders if the FDA “rule-making” process in progress allows (between now and that time) for a “public comment” process. One might think that some of the recipients of the reported 120 Million hydrocodone prescriptions each year in the US would have something to say – if they come to understand the implications surrounding the more stringent and laborious Schedule II requirements (as opposed to Schedule III requirements).

    Judging from the (relative) obscurity of the article quoted from above, don’t count on the Press to be of much assistance in helping the public figure things out.

    However *physicians* will understand the differences, and might want to make their opinions known to the FDA in the interim time ahead …

    The whole idea of the (over-the-counter!) acetaminophen being the substantive issue has not made much common sense – whereas (if true) an increased level of control of hydrocodone via the above Regulatory change *does*.
    .
    .

  • Doctor Rocktor

    BIG BROTHER WANTS YOU TO WANT HIM

    UPDATE: Verification that (at least certain) hydrocodone products complexed with acetaminophen are presently Schedule III under federal drug controls is verified by this FDA communication at:
    http://www.pharmcast.com/WarningLetters/Yr2008/Dec2008/VictoryPharma1208.htm

    WHAT THE FDA (APPEARS TO BE) UP TO

    What appears to be the relevant FDA Meeting announcement (and time window now passed for public comment) is at:
    http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm

    From the FDA’s own textual content:

    “Public Participation and Sponsor Information:
    Interested persons and Sponsors (representatives from industry) may present data, information, or views, orally or in writing, on issues pending before the committee.
    Electronic and written submissions may be made to the Docket on or before June 8th 2009.”

    and

    “Oral presentations from the public (excluding Sponsors) will be scheduled between approximately 1 p.m. and 2 p.m on both days, June 29 and June 30, 2009.”

    The meeting’s “Briefing Materials” are at:
    http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm161515.htm

    “Meeting Materials” are at:
    http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm126014.htm

    See the FDA meeting issue Background Document at:
    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf

    Note that in the relevant Option 1(a) and Option 1(b) propose limitation 325 mg per any single tablet/capsule for OTC sales, (as well) as possible inclusion of prescription formulations (this a condition already met by existing Percocet, Endocet, etc. as currently formulated).

    The publicized possibility of the removal of “Percocet” from the market arises out of the possibility of the full implementation of Option 5(b) to all prescription medications that currently contain acetaminophen complexed within the product in any form.

    Option 5(b) relates to “Eliminate combination Rx Acetaminophen products” (PDF, Page 16 of 21).
    In the excerpt quoted below, the FDA (silently)
    acknowledges knowledge of the impact of such an
    implementation of Option 5(b) (that is, eliminating hydrocodone formulations with acetaminophen that are presently under Schedule III) by merely stating in regards to Schedule II prescriptions that only 30-day supplies can be dispensed under Schedule II Regulations (as opposed to 90-day supplies under Schedule III Regulations):

    “… patients are required to fill prescriptions monthly to comply with the restrictions imposed by the Controlled Substances Act, rather than being able to obtain a three-month supply with one visit to the pharmacy. This could represent a substantial burden for elderly patients and others with limited mobility as well as for patients who live at a distance from a pharmacy.”
    (PDF Page 16 of 21, Sixth Paragraph)

    It does appear that what is *not* said by the FDA (in any direct way) is the single most significant long-term down-side of banning all Schedule III hydrocodone products. Nice of the Press to miss the pithy core …

    In the (one might hope, more short-term interim period) the some 460,000 prescriptions reported to be written and filled each and every business day in the USA for hydrocodone will *just have to wait*, as, there being no (Schedule II) hydrocodone-only products on the market at the present:

    “For development of hydrocodone single-agent formulations, implementation would include:

    Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.”

    While the public (thanks in large part to the “Press”) will *not* likely grasp the implications of such an (effective) rescheduling of existing Schedule III hydrocodone products (accomplished by prohibiting them) to a Schedule II hydrocodone (only) product(s) that do not currently even exist …

    Physicians/institutions involved in the generation of the 120 Million annual prescriptions for hydrocodone would be (it seems) well advised to “make a lot of noise” to the FDA (with or without a “public comment period” being in effect) to avert a protracted juggernaut of “pain and suffering” for patients as well as medical professionals alike!

    Physicians cannot prescribe products that do not exist on the market (regardless of Schedule status). How does the FDA justify making such a “brain-dead” move within the next few months? (Please) “Talk amongst yourselves” … ;)
    .

  • Anom

    I love the fact that responsibility is not being taken by patients. If you take more than you are prescribed its your fault. If you are doing what your supposed to be doing then you should not be punished for someone else. In regards to the FDA its amazing how a medication like afrin nasal spray that is addictive after just 3 days is OTC yet tylanol is now going to require a script. And people think that there comments will count on this mannor. The gov will do what they want when they want period.

  • Doctor Rocktor

    Anom wrote:

    “And people think that there comments will count on this mannor.”

    Maybe, maybe *not*, Anom.

    Nearly half a million doctors and patients prescribing and filling prescriptions for hydrocodone formulations every single working day have a direct interest in the matter.

    It’s true that the FDA’s “public comment” time window has passed. It is not *necessarily* true that the FDA has deaf ears to millions of people (patients, physicians, and medical institutions) making their thoughts known via the Press …

    Take a look at what the FDA back-tracked on recently regarding eliminating opioid medications in just a few months ago (April of 2009) at:

    http://www.associatedcontent.com/article/1649765/fda_reverses_decision_on_opoid_availability.html?cat=5#comments

    “Power never concedes without a demand, it never has and it never will.”
    -Fredrick Douglas
    .

  • Pam

    Went to the pharmacy today and asked about the whole thing and what they knew. She said I probably know as much as they do…they are being kept in the dark also as to what is going to happen down the road.

  • Doctor Rocktor

    Pharmacists, Assistants, Physicians, Hospitals, HMOs, etc. are not likely to be the first jeopardize their standing and livelihoods by stepping forth into the political spheres (a little bird tells me) …

    Patients, on the other hand, would appear (even to the lowliest members of your medical “team”) be likely to be labeled as “phobic” (as they like to write) regarding your potential future ability to consume certain specifically identified (Schedule II or Schedule III) opiates/opioids.

    I would not expect more than duly raised eyebrows, and the potential birth of an immediate and lasting suspicion as to your level of knowledge and interest in such lofty matters as the adequate relief of your pain under the wise and all-powerful benevolent hands of the “Theraputic State”.

    Such subjectively originated and duly recorded judgments on the part of any member of your “health-care-team” may well find their way into your medical records – to be shared with insurance companies, your employers, etc., for the rest of your days, (essentially) completely outside your ability as an individual to question, modify, or appeal.

    In Newspeak – “War is Peace; Freedom is Slavery; Ignorance is Strength”, to the result that “insincerity” becomes the adversary and nemesis of “clear language”.

    Trust your own first-hand knowledge and intuition first and foremost, knowing that your physicians exist only one-rung upwards from yours on the labyrinthine and hollow Ziggurat of Babylon.

    For instance (did you know) that (if) you have health insurance through any kind of “group” plan (such as one’s employer, whether insured or self-insured), neither YOU the insured patient, or your representatives (outside of subpoena under ongoing court proceedings) possess any right whatsoever (in any state in the nation that I know of) to view the actual text (and the terms and conditions set forth within) of the formal written contract between the “Provider” of the insurance policy and the “Owner” of the insurance policy (that “Owner” being the “group organization”, and NOT the individual patient).

    The specious for-profit-insurance driven nightmare of duplicities on the part of physicians and patients alike, (all cowering under threat of ostracization from our peers) that has correspondingly evolved in our society today has/will make patients (and perhaps, some physicians) later cringe in regret for so (naively) trusting in faceless and secretive organizations run by attorneys and actuarials (to the ultimate detriment of physicians and patients alike).

    “We call first truths those we discover after all the others.”
    -Albert Camus

    One (truly) needs dual degrees in medicine and law to see to it that one’s own life as a patient proceeds, grows frail, and one day dies in a manner freely chosen by the competent, informed, and autonomous individuals that many of us would like to believe that we should bear a inaliable human right to be!
    .

  • Docktor Rocktor

    TRAGIC AND AVOIDABLE IRONIES ABOUND, INDEED

    I watched one of the high-ranking FDA officials, when speaking publicly in an open meeting, make a “sublingual slip” when addressing the matter of the acetaminophen presently complexed together with (most of the) oxycodone and (reportedly all of the) hydrocodone analgesics, as an impact of the potential adoption of Proposal 5(b) in their June 29-30, 2009.

    The FDA official was in the middle of such a related sentence when he said (something substantively equivalent in meaning to):

    “… eliminating the opioids … … … excuse me, I meant to say, eliminating the acetaminophen … from …”.

    In a separate video clip of the FDA post-decison press conference an FDA official confirms to the press that they have *not* (to that date) made *any* requests of the manufacturers of such opioid/acetaminophen analgesic products to volutarily “unbundle” the acetaminophen from the products. (That particular) FDA statement begins precisely 6 minutes into the video that can be viewed at:
    http://www.youtube.com/watch?v=MDmBzHHsvbM

    It begs the question whether the FDA’s potential actions under their “Option 5(b)” is an intentional way for them to ignore doing “with a scalpel” what they see a political opportunity to instead do “with a hammer”. The (effective) rescheduling of the potential implementation of “Option 5(b)” by the FDA – moving hydrocodone (from Schedule III as complexed with acetaminophen) to Schedule II (when administered on its own without such complexing) – has been previously identified, and commented upon within this same discussion thread.

    Given that (hydrocodone only) products for human consumption reportedly do not presently exist on the pharmaceutical market, the time delays for even a (Schedule II) hydrocodone product to become available (in order to even be able to be prescribed) appear uncertain, and (by the FDA’s own written statements) potentially lengthly, complicated, and prohibitive).

    Such a move on the part of the FDA would dramatically impact drug controls – without even having to persuade Congress to amend the Controlled Substances Act. And prescribing physicians know (better than most patients) that such an (effective) “rescheduling” would have detrimental consequences (for physicians and patients alike) where it come to prescribing/dispensing of opioid medications, adversely affecting the corresponding adequacy of pain treatment that those patients receive.

    A *scientific* irony is that the actual analgesic effect of the (typically, 325mg or 500mg of) acetaminophen – relative to the net analgesic effect of (even the minimal cases of) 5mg dosages of the opiods hydrocodone and oxycodone – makes *little or no* objectively substantiated measurable difference, anyway! Please cite examples of published case studies if you disagree (where it comes to the moderate/severe levels of pain for which these opioids are indicated as a treatment).Thus, we must look to the realm of *emotion* (as opposed to demonstrable fact) for an explanation of “why?”.

    As a result of the truth of the matter stated in the paragraph directly above, a *moral* irony is that this “complexing” (of acetaminophen within these products) has evolved and been sustained more out of a moral judgment using (phony) “numbers games” that exist far more as a “rhetorical placebo” than out of the result of demonstrable science-based reality.

    Returning to the matter of scientific physiological findings where it comes to potential renal (in addition to hepatic) damages caused by the heavy daily usage of NSAIDs in patients. *Many* of those patients would not necessarily have to resort to such dangerously high NSAID dosing regimens were it not for the under-treatment by the medical profession of their moderate/severe chronic pain with opioids that arises out of the moral, political, legal, and reputational concerns and fears that physicians find themselves embroiled within as agents (of our own interests), of the State, and of our Employers.

    Additionally, regimens that *combine* aspirin and acetaminophen (together, as well as when additionally combined with opiates/opioids) are widely suspected to be a significant factor in medication-caused renal damage.

    The above tragic (and likely unnecessary) adverse impact – potentially contributing to a situation where roughly 1 in 7 adults are reported to be in some stage of chronic renal failure (CRF) – is, it seems, a boon for the sales of the 7-12 very profitable medications that are (typically) simultaneously prescribed to patients with end-stage renal disease (ESRD).

    Tragic, cruel, inhumane, and malignant ironies here abound. Few would argue that the extraordinary and multifaceted costs (for patients, as well as taxpayers) surrounding hepatic and renal organ failure in patients are a necessary or worthwhile trade-off for the further perpetuation of baseless and (themselves, by far, *more*) toxic orthodoxies arising out of *moral* ideologies alone.

    We should be saying, “WHY?”, and *not* accepting the patent fallacy that it is in the best interests of pain patients to risk permanent (renal as well as hepatic) damage so that moral ideologues will rest easier – knowing that people who experience chronic moderate/severe pain are risking the physiological health of their major organs (thus, their very mortality) in order that the members of a bogus (and morally, not physiologically, based) cult of drug-avoidance will experience an ongoing sense of “well-being” (about the scriptures and strictures controlling the lives of persons *other than themselves*, it is noted).

    Yet, (little or) no “free market” in such patient advocacy on the part of physicians exists – as the State, with the assent and assistance of our private for-profit health care system, proffers only dis-incentives and penalties (both real and imagined) for those who (rightly) might question such misplaced and detrimental (endemically) “moral orthodoxy” – engendered and sustained without significant rational basis in pharmacological fact – and in the midst of finding that high usage amounts of NSAIDs are (themselves) far more detrimental on a *toxicological* basis …

    On balance, and in the historical retrospect, we may find that the primary net effect of the War on Drugs was to endanger and denigrate the physiological health of our society, via a pantheon of (albeit perhaps once previously unintended and unrecognized) tragic consequences.

    Could (and should) we as a medical profession as well as a society not (honestly and substantively) ask the question, “who’s interests are *really* being served”, here? And (honestly), at what level of hierarchy on this “ladder of controls” exists the (ostensibly being served) patients’ best interests?
    .

  • Doctor Rocktor

    LET THE FDA AND THE PUBLIC KNOW YOUR OPPOSITION TO THEIR PROPOSED “OPTION 5(b)” (EFFECTIVELY) RESCHEDULING HYDROCODONE FROM SHEDULE III TO SCHEDULE II

    In my post directly above, I (individually) opined:

    ” … the actual analgesic effect of the (typically, 325mg or 500mg of) acetaminophen – relative to the net analgesic effect of (even the minimal cases of) 5mg dosages of the opiods hydrocodone and oxycodone – makes *little or no* objectively substantiated measurable difference, anyway!”

    Where it comes to the effectiveness of such complexing (of acetaminophen with opioids) and *chronic* pain – sure enough (according to the FDA themselves):

    ” ANALGESIC EFFICACY IN CHRONIC PAIN

    The analgesic effects of the opioid/APAP combination in patients with chronic pain have
    been much less studied. There were no factorial design studies identified in the literature
    to assess the analgesic superiority of opioid/APAP combination over the individual
    components in any chronic pain patient population. Randomized controlled studies of
    opioids for chronic pain in the literature mostly focus on opioid single-entity products
    other than opioid/APAP combination and only a few studies included a treatment arm of
    opioid/APAP combination products. Most of these studies were discussed in published
    systematic reviews in 200426 and 200527 or meta-analyses in 200628 and 200729. However,
    the evidence level from these studies to support opioids for management of chronic pain
    is ‘Limited’, as concluded in the Opioid Guidelines in the Management of Chronic Non-
    Cancer Pain1. ”

    Source: from (PDF page 80 of 100) at:
    http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064809d138c&disposition=attachment&contentType=pdf

    Although the (formal) “public comment period” is stated by the FDA (in the following document) to have ended:
    http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm

    … it is (nevertheless, and for what it may be worth) possible to post (anonymously, as we prefer it in the less-than-benign “Theraputic State”) comments relating to this matter at the FDA’s (… moderated) “blogsite” at:
    http://fdatransparencyblog.fda.gov/comment-policy.html

    Here is the particular docket entry and identifier for this issue taken up in the FDA’s recent June 29-30, 2009 meetings surrounding these matters of acetaminophen:
    http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064809d138c

    Your actual blog entry itself can be entered at:
    http://www.regulations.gov/search/index.jsp

    (At least) there exists (if the FDA blog-site moderator(s) don’t nix your comments) a vehicle by which your input can (still) be publicly stated in a manner that (might even) be read by agency officials. Who knows – someone somewhere *might* actually take your opinions, and your thoughts, seriously … one/we can dream, anyway … ;)

    Cutting to the chase in these matters – eliminating the acetaminophen content, (and allowing patients to self-administer OTC acetaminophen) sounds like a “no-brainer”) as such complexing appears more to be an emotional and moral artifact (as opposed to demonstrably necessary or significant in terms of evidence-based science), anyway. Let us not ignore the essential truth of the fact that such complexing with acetaminophen (in the case of the opioids hydrocodone and oxycodone) is largely unnecessary, and arises largely out of emotion and moral orthodoxies – rather than demonstrable reality.

    In a (simple) world, the manufacturers could easily dump the acetaminophen from their products in a matter of days. It is not necessary as a stabilizing or preservative element in the formulation of the medications, period.

    Alternatively (and more practically), the per-dosage amounts of acetaminophen complexed within the existing (Schedule III) hydrocodone products could easily be dramatically reduce, in order to address the (cumulative) acetaminophen hepatic toxicity concern. It makes little sense to allow OTC sales of acetaminophen (which should rightly continue), while “hand-wringing” about current opioid medications that contain relatively small amounts of acetaminophen, anyway.

    The unspoken likely truth is that much of the hepatic toxicity of acetaminophen (very likely) arises out of it’s concomitant use with our society’s “poison of choice” (ethanol, to which we choose not to demonize, having – wisely – come to our senses as to the futility of it’s prohibition).

    In the *real* world (as we suffer it’s juggernauts of bulbous, bureaucratic nightmares) – real and substantive potential harm of these actions exists in terms of the collateral damage arising out of legal (as in the controlled substance scheduling status of hydrocodone resultantly changing as a result from Schedule III to Schedule II), as well as bureaucratic imbroglios:

    [1] As in *long and protracted* FDA procedures to be satisfied in order to bring such a hydrocodone (only) product to market – as none reportedly currently exist for human consumption), likely also resulting in higher costs being charged (to patients and institutions alike) by “big-pharma” for such newer products; and

    [2] The “chilling effect” upon physicians (and patients alike), due to the political and reputational issues arising out of the frequency and volume with which a physician prescribes the (more) tabooed Schedule II medications; and

    [3] The corresponding limitations and requirements surrounding the prescription/dispensing of Schedule II medications, such as: requirements of hard-copy paper prescriptions (as opposed verbal specification); and requirements of a maximum 30-day (as opposed to a 90-day) supply being dispensed by pharmacists at any one time; and restrictions on the ability for pharmacies to deliver such Schedule II medications via mail/delivery services, etc.

    Prescribing physicians are in the unique position to well know the practical problems and barriers that such actions by the FDA would create (and speak up …!) – whereas the vast majority of affected patients are likely to only realize the downsides of such a “new regime” post-facto (and a lot of good that will do them, eh?).

    How about the idea of physicians advocating the patients’ interests (not to mention our own interests where it comes to the ability to provide adequate pain relief using hydrocodone in the future), and speaking-up (to their Employers, pharmacy boards, and the almighty FDA) *before* (as opposed to after) such harm may occur?

    And that’s the way it is, Friday, July 17, 2009 …
    Goodnight Walter, Chet, and David, … and good luck!
    .

  • Dr House

    They talk about removing Percocet and Vicodin from the market,, which I think is (BS) but if they did the people who use Percocet can have there doctor write a prescription for Roxicodone which comes in 5mg, 15mg and 30mg, there is also a generic as well. Roxicodone just contains Oxycodone and does not have any Tylenol added. So both Percocet and Roxicodone contain the same main ingredient which = OXYCODONE.

    The funny thing is that Alcohol has destroyed more lives through addiction and killing people and nobody has done nothing to remove that from the market, this just continues to anger me so it is time to go

  • Doctor Rocktor

    Dr House -

    What you say regarding (Schedule II) oxycodone is true enough, indeed. Roxane does presently offer oxycodone (only), as does Purdue’s Oxycontin.

    Nevertheless, in the case of hydrocodone, federal law requires that it (both) be: offered in a dosage less than 15mg; *and, as well* be combined along with some other medicinal agent, in order to fall under Schedule III (as opposed to Schedule II). See (DEA #9806) at:
    http://www.usdoj.gov/dea/pubs/scheduling.html

    With NSAIDs (other than acetaminophen) known to cause even more gastric disturbances and potential damage, it’s hard to imagine what might be substituted for acetaminophen as the “other medicinal agent”. Further, the FDA policy would require prolonged “efficacy studies” to be concluded before such a product could be supplied.

    I concur with you that ethanol (well known to cause some liver cell damage upon ingestion in any dosage amount) has (and will continue) to cause far more physiological damages than any direct physiological impacts of opiate/opioid use. Yet, our society’s efforts in the early 20th century to prohibit it were not only ineffective – they were counterproductive and far more damaging, themselves (in terms of health, safety, criminal activity, etc.) …

    Indeed, we live in a strange world of inverted values and sensibilities. Perhaps the United State’s (rather unique and demonstrably fruitless) efforts to allow the State to decide what competent adults ought – or ought not – ingest in the course of peaceful private activities is a failed agenda that (in the final analysis) benefits only the culture of “life-coaches”, medical “supervisors”, law enforcement agencies, and the (more and more privatized) prison system. Around one half of the (unparalleled in any other society) 2 million people incarcerated in the United States are in prison for drug crimes.

    Again, I ask the question, “exactly *whose* best interests are being served here?” … And, is it those citizens who are (ostensibly, allegedly) said to be the rightful beneficiaries of such social policies (for whose benefit and safety those policies were – allegedly – instituted)?
    .

  • Doctor Rocktor

    IN THE NEWS – (published) July 20, 2009

    FDA spokesperson Karen Riley stated to the press:

    ” … regulators are expected to take as long as six months to consider the repercussions for patients, said spokeswoman Karen Riley.”

    and

    “Changing dosing recommendations on Tylenol would take years, said the FDA’s Riley, and the agency is well aware of the concerns of people who rely on Percocet and Vicodin.”

    and

    “I think you’ll find that this will be a measured response you don’t want to have unintended consequences,” she said, adding that labeling changes would be an option that could happen relatively quickly.”

    http://www.columbusdispatch.com/live/content/local_news/stories/2009/07/20/WHATNOW.ART_ART_07-20-09_A1_FHEHA9F.html?sid=101

    “A new national media study among 589 physicians revealed that the majority of physicians (82%) do not believe that drugs containing acetaminophen should be pulled off the market.”
    http://sev.prnewswire.com/null/20090720/NY4906620072009-1.html
    .

  • Julia

    I think maybe the death of someone famous was the eye opener the country needed where addiction is concerned. In May my husband passed away from Hydrocodone intoxication, he didn’t feel he was doing anything wrong because he was addicted. (after all the Dr. was perscribing) After a second back surgery 9 yrs. ago the Drs. started perscribing Hydrocone for pain. A couple of years ago he started seeing a new Dr. who did not check liver enzymes, was not concerned about weght loss, nausea and vomiting were said too be the flu, and high blood pressure was blamed on stress. The autopsey showed his liver was 2x the normal size, he had high levels of Hydrocodone, his liver couldn’t process the meds. He was at the Drs. office less than 24 hrs. before death, Dr. said he had the flu and refilled his script.

  • Debbie

    I am pushing 50 and have degenerative spine desease and chronic arthritis. I got hurt on the job slipping on grease and all this started I have been in pain ever since which was october of 2004. I was on percocet and morphine 30′s the morphine made me sick so I stopped taking it now I’m on tramadol and ibuprofin 800 and they make my stomach so sick and don’t help with the pain but it is all you can get in my town. I don’t know why everyone who doesn’t have pain and sell their drugs on the street can get a Rx and I can’t and my friend who has rheumatoind arthritis and a broken ankle and needs knee replacement can’t get them from these drs. If they take them of the market people will just make and sell them illegally and rob and steal to get them. The Drs around here don’t give them anyways so whats the problem. I have tried everything. I am now taking 4 tylenol arthritis 650mg and that cannot be good for me it hurts my stomach. I cannot function or get out of bed without taking something stronger. What’s the problem people.
    GET REAL!
    In pain and crying.
    Debbie

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