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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