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FDA Votes To Take Vicodin and Percocet OFF The Market – What Does This Mean For You?

http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing/index.html

OK. Well, not really sure how to react to this decision but it seems like politics as usual in Washington…The FDA has voted to take Vicodin and Percocet off the market which may be a good decision but it’s for the wrong reason.

The FDA panel narrowly voted to advise that manufacturers take Vicodin and Percocet off the market due to the presence of Acetaminophen (Tylenol). Now let me just say right here that this does NOT mean that these drugs will be taken off the market; all this means is that the FDA Advisory Panel has advised the FDA to do so. The FDA can choose to disregard this advice although historically, they often heed the panel’s recommendations. They cite numerous incidents of liver damage due to high levels of Acetaminophen. In the pain management community, this has been a long debate and I think it’s ridiculous because most people do not take nearly enough of either drug to harm their liver based on the statistics that I have read. But I’m not a doctor.

Ok, so if you’re taking 6-8 Vicodin per day (5/500) that’s a max of about 4,000 mg’s. The panel’s rationale was that there was an increasing number of patients admitted to the ER due to high liver toxicity levels and a growing number of over-doses due to the loss of liver function. What about all of the people dying due to overdoses of opiates??? It far surpasses that of people who have died due to Acetaminophen. The normal doses of Vicodin or Percocet aren’t really even close to what one needs to take in order to really test their liver based on the statistics. We’re talking about people who take maybe 20-30 pills a day like I did. Now that doesn’t mean, “hey George said it was ok to take 30, let’s party!” it means that in my opinion based on the statistics that I have read that the risk of dying from the narcotic (Hydrocodone in the case of Vicodin and Oxycodone in the case of Percocet) are far greater than that of taking too much Tylenol. The reason why Tylenol is in these drugs is that it helps “turbo-charge” the narcotic’s analgesic effects. Now they will just be prescribed together but separately. As I mentioned, the FDA may have had good reason to take these medications off the market but the reasons why they did are a bit off the mark in my opinion.

I could get all technical and write an analysis about liver toxicity and how much Acetaminophen a body can take etc. etc. but that would be boring wouldn’t it? I’m going to write about what this means to the people out there who are on these two drugs. So what does this mean for you?

What If I Am Currently Taking Either Vicodin Or Percocet As Directed By A Physician? Will I Have To Quit?

Of course not. Again, this vote does NOT mean that they are both officially banned. What it means is that the FDA has recommended that they be taken off the market. Usually however, the FDA and manufacturers comply with these recommendations so you can expect that in all likelihood, within the next few months, Vicodin and Percocet in their current forms are going to be phased out. If you are in chronic pain and are in need of narcotic medications, believe me; you will still have access to them. The main ingredients in Vicodin and Percocet are Hydrocodone and Oxycodone respectively. These two drugs are widely prescribed and their manufacturers will simply take out the Acetaminophen and either substitute it with another ingredient or leave it out altogether. Cynically, there’s just too much money in these drugs to simply take them off the market. In addition, these are extremely valuable clinical tools that clinicians need to treat acute and chronic pain.

There are tens of millions of people out there taking these narcotic pain killers for viable reasons and they will continue to do so. I don’t think that anybody would argue that narcotic pain killers aren’t essential for many people and if you take them for a legitimate reason, don’t worry, you won’t have to quit all of a sudden. You might simply have to take a different (new) type of drug or maybe 2 pills instead of one.

So it’s not the access to narcotics that you should worry about if you are in pain; it’s the cost. You see, now the makers of Vicodin and Percocet have to go and make “new formulations” of the same drug which will provide some patent protection for them for a few years. Coincidence? Possibly…probably not. I think you will likely see new brands of your same pain killer without Acetaminophen that are no longer generic. If that happens, you can expect to pay a lot more for your drugs going forward. That would be an outrage in my opinion, because it would appear that the decision to take these drugs off the market due to Acetaminophen is simply the result of some lobbying on the part of pharmaceutical makers in what would be a slap-in-the-face money grab.

If that is the case, then in the future if your doctor prescribes a “new” drug that does not have a generic equivalent then ask him to consider alternatives that do have generic equivalents. The problem with that is that the FDA just happened to pick the two most fundamental narcotic painkillers (Hydrocodone and Oxycodone) that represent 90% of the opiate painkiller market. It might be difficult to find generic equivalents of either of these two ingredients going forward since they are ubiquitous opioids/opiates. We’ll see but in the meantime, whatever happens, don’t worry. You will not have to go without any prescription painkillers for your chronic or acute pain; there’s just too many people out there that really need it.

What If I’m Addicted To Vicodin or Percocet and I Don’t Get Them From a Doctor?

As I mention above, generic equivalents to these drugs may not be available anymore which will really make these two drugs very very scarce (therefore very expensive) in the short term. Within a year, one can reasonably expect that they will no longer be available. I never got my pills illegally so I’m not very informed about the nuances of buying these drugs off the street, on the internet or at these “Doctor in the Box” pain clinics. Therefore, I’m not really sure when the supply would dry up. But it’s not hard to come to the conclusion that Vicodin and Percocet will eventually be gone in their current form. I have to think that if you are getting these drugs illegally right now that this vote by the FDA is going to put an end to that sooner or later.

So what are your options? Well if you choose to continue to use illegally (Authors note: Of course I’m not recommending or condoning illicit drug use; I’m just stating the obvious facts); you either find a new drug, you wait and see if some new formulation of Vicodin or Percocet hits the market or you possibly find foreign equivalents if there are any. This should concern you because it will not only represent a significant increase in the cost of these drugs but also introduces a seedier and possibly more dangerous prospect when taking foreign or very scarce narcotics.

The other obvious choice would be to simply quit altogether which is what I try to convince people to do. Quite honestly, I really don’t know what this means for the illegal trade of these two painkillers but it doesn’t take a rocket scientist to realize that if the manufacturers stop making them, they will eventually dry up. It’s really hard to make a prediction; prohibition of alcohol didn’t take away alcohol, it just went underground. Could this happen to painkillers? Possibly. The pharmaceutical industry is far more regulated than the distilled spirits industry was during prohibition. They can’t just keep making these drugs without a legal market for them.

What also worries me is that without access to these two drugs and with treatment options still limited as I mentioned in another one of my blogs, that people will migrate to stronger drugs like Heroin, Dilaudid, Meth etc. I’m deeply concerned that people will take the path of least resistance and if a stronger drug is more readily available then people will take that instead. That would be a very bad outcome.

My Conclusion:

I think that the death of Michael Jackson has shed some light on the prescription pain-killer issue in the US in a way that Anna Nicole never could. Let’s face it, he was an American Icon; she was a Playboy model…her most illustrious achievement. Nobody will be quite sure what happened to Michael but just the presumptions have been enough to get prescription drug issues to the top of the news cycle while we await his toxicology results. I think the FDA vote was a preemptive gesture to make sure that America knows the FDA is engaged when it comes to the prescription drug epidemic in the US. Ultimately, I can think of a plethora of more effective steps to stem the tide of fatalities due to prescription drugs but it’s a step in the right direction I suppose. The thing that worries me however are the few things that I discussed above. Is this going to increase the cost of pain medications to those that truly need it? Is this vote going to make it more dangerous and costly to get drugs for the people that don’t? Will people migrate to more readily available and more potent alternatives?

We’ll have to wait and see but I think we need to hope for some other legislation that caps the cost of these drugs going forward for legitimate use so that chronic pain sufferers don’t get shafted by drug companies. And for those of you that are using illegally, I would hope that making these drugs less available to you is coupled with legislation that makes recovery and sound treatment options more accessible.

Ultimately, some of you are going to be forced to make a change in your life as a result of this vote. Hopefully, you’ll make the right choice.

-George

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Comments

  1. Nishkama says:

    My question is WHY NOW? The FDA has obviously known for years that tylenol has that effect on the liver in high doses. So what are people who are truly in chronic pain going to do? These are the low level opiates they are considering on banning…so someone taking oxycodone 4x daily will now have to switch to oxycontin or Morphine…putting them in a more dangerous bracket of pain management and/or addiction. I dont agree with this decision…Im on pain managment myself…and beleive the tylenol only causes damage if you take more than the Dr prescribed…I hope that they offer alternatives that help…not hinder those in need.

  2. mommy in pain says:

    I am concerned!! I have chronic pain with spinal stenosis due to herniated discs with arthritis setting in, causing me to have constant, AWFUL siatica…it’s been so hard this year especially. I have a little boy who will be 3 in August and I struggle to care for him and keep the house up…it’s even hard to be comfortable at work and I sit at a desk all day!! I’ve tried a few different medications and I have even lost 35 lbs and joined a gym, thinking that the weight loss and exercise may help the constant pain in my lower back and the numbness and cramping in my legs..but it didn’t–it has gotten worse. I am currently taking 7.5 mg of Oxycodone 2x a day for the pain and it helps the pain the best so far but when they wear off, I have a dull cramping feeling mostly in my legs but in the back too until I allow myself to take another when I get home from work (so I can take care of my boy!)Sometimes the pain is really bad and I have no choice but to take like a pill and a half.
    What will happen to me if they take this medicine off the market? I am actually going to be seen at a pain management clinic very soon and I was hoping that they might be able to perhaps give me an extended relief form of this drug or at least up my dose (I’m afraid to run out–then I will be in pain.) I’m also open to the injections ect…anything to be out of pain, but i heard they do not always work..i was given a pain shot of Turmodol (? or something by a name similar to that) twice by my reg Dr. and it did nothing!!
    This sucks..any suggestions…or any ideas as to what they may to for me at pain management? Thanx in advance.

    • Hi. Don’t Worry. As I mention in the article, if you are a chronic pain sufferer, you will be taken care of and there will be something out there for you. Your medication will not be taken away from you at all.

      • Went yesterday to get refill for my Lorcet 10 and was told it was taken off the market… I’m now on a new med that I have never heard of Norco… I hope that it helps… Would love to take a hammer to the head of the FDA’s spine and see how they do without their meds… I broke my back, have 8 Herrington rods, developed scoliosis above and below the rods, two herniated discs, spinal fluid leakage and degenerative disc disease. Every day is pain… They need to know what pain is before making these decisions…

        • Hi Katrina. Norco is Hydrocodone and Acetaminophen. Same stuff and Lortab just different brand and perhaps different acetaminophen content.

  3. George: any reports of success with this product and coming off suboxone?

  4. my husbad hurt his back in 1997 an he takes 6 loratab 10/500 a total of 6 tims daily since then .Can u recommend anything he could ask his dr’ for that not so hard on his liver and is still affordable he has no insurance.
    Thank You

    • Hi Lumpas the Wife! you husband has been on the same dose of the same meds for 13 years? sounds a bit strange. He’s not taking enough to cause him any liver damage…nevertheless, he should have a blood test/liver panel done once every year just to check. This can be done with his regular bloodwork and is usually included.

  5. yvette taylor says:

    i want ntto ask you a question why is it that we cant get the vicodin and the perocet im on both of them i use it like the dr told me to take it will it be able jan.1st 2014 yes or no you can e-mail me and let me know pleasewhat will the generic be now im taken generic kind if they stop makimg them all together i ont know what to do

    • Hello Yvette. Just to clarify, this was a recommendation from the FDA to take these products off of the market for a couple reasons including Tylenol content as well as the increased incidence of abuse. The DEA can re-classify based on this recommendation but I had not heard of any new news on this front until a couple months ago when The FDA voted to recommend re-classifying these drugs. Again, whether the DEA actually does this is unclear. There are a lot of politics and money involved here so the outcome will be based on that; not the public good.

  6. I am currently on hydrocodone 10/325 for chronic pain post cervical fusion that did not help. I have been on this for the past 2 years with tramadol for breakthrough pain as this is the only regimen that allows me to participate in the daily activities of my household including caring for my 5 year old daughter. I recently started Cymbalta a couple of months ago in hopes of some pain relief that would allow me to cut back on my hydrocodone, however, it did not relieve my pain so I notified my doctor’s office. His receptionist, yes I said receptionist, called me today and said he was placing me on wellbutrin and tramadol for pain and to stop taking the hydrocodone because they were going to stop making it. I realize, as a nurse, that this is absurd and absolutely untrue. I have placed a call in to his nurse and am waiting for a response, however, she seems to agree with the receptionist. How can an unlicensed person even be the one to call and tell me such a thing? Any advice as to what direction I should take from here? Surely they cant just take me off of this when it is the only thing that somewhat even seems to help.

    • Hi Amy. Get thee to a new doctor. I’m sure you anticipated this type of response from me. Of course they have NOT stopped making Hydrocodone. It’s handed out like candy. The FDA advisory panel is a group of health and human resource professionals who look at evidence and then issues warnings or recommendations on a variety of different topics. They have issued a recommendation to take Percocet off of the market due to the Acetaminophen content which I think is absurd but that’s me.

      They have also voted to re-classify Hydrocodone into a stronger class of drugs that make it more difficult to forge prescriptions.

      The Drug Enforcement Agency is the government body that actually either accepts or rejects these recommendations and is also in charge of enforcing them. Just because the FDA votes on these matters does not mean to suggest that it is imminent or in force at that very instant.

      I’m sorry that you went through that.

      In any case, a receptionist calling you to say that they are going to put you on Tramadol because hydrocodone is not prescribed anymore is the height of arrogance and it is clear that they do not value you as a patient.

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