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Feds Out of Control, Part II

Looks like the FDA panel considering regulatory changes to acetominophen has decided that Percoset and Vicodin have to go.  This is going to essentially mean that people who have procedures that cause mild to severe pain, like having wisdom teeth removed, or having a minor surgery, are going to find it very difficult to find pain relief.

Percoset and Vicodin are both combination therapies, combing acetaminophen with oxycodone, in the case of Percoset, and hydrocodone, in the case of Vicodin.  Because of this, they are Schedule III drug under the Controlled Substances Act.  Regulators feel the acetaminophen content makes the drug less likely to be abused, so it is so classified.  That doesn’t stop people from trying, however, and a number of people each year fry their livers either by taking too much, or because they did some failed home chemistry trying to separate the narcotic drug from its codrug.

Oxycodone and hydrocodone, on their own, are both Schedule II drugs, meaning they have a theraputic use, but are likely to cause addiction and be abused.  Doctors are very reluctant to prescribe Schedule II drug, because they attract more heat from regulators.  There are also additional restrictions on Schedule II drugs, such as a doctor’s office not being able to call in a new prescription (it takes a physical, written prescription to make changes to dose, or get a refill).  If this is the only option available, many doctors, oral surgeons, periodontists, and various other medical professionals who often have a need to treat pain, are less likely to prescribe narcotic pain killers.   While this would probably be just fine by regulators, if you’re in pain and can’t find relief, a narcotic is often the only thing that will do the job.

Fortunately, there are a few alternatives, although they are expensive.  One is Vicoprofen, which is a combination of ibuprofen and vicodin.  For many people, it’s a viable alternative to narcotics in combination with acetaminaphen, but for many people, it is not.  Particularly people with gastrointestinal disorders, people taking blood thinners, or people with inflammatory bowel disease.  Another is good old fashioned Tylenol with Codeine, but unfortunately, for 10% or so of the population, their livers lack the enzyme necessary to convert codeine to morphine, which makes the drug’s narcotic component useless to them.

Don’t think, either, that just because many OTC pain releivers and many narcotics are both GRAS, or Generally Reocnigzed as Safe, that you can just combine them at will, and sell them on the market.  Combination therapies have to go through the FDA approval process as if they were new drugs, which means major costs to do the clinical trials.  No pharmaceutical company is going to do that without patent protection.  In short, if Vicoprofen doesn’t work for you, you’re screwed.  You can suffer in pain.  Hope and Change has come, folks!

6 Responses to “Feds Out of Control, Part II”

  1. Bob S. says:

    There are also people with Asthma that should not take ibuprofen type pain relievers.

    Between 8 – 20% of adult asthmatics experience bronchospasm following ingestion of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Termed aspirin-induced asthma, this reaction is potentially fatal. Asthmatics with chronic rhinitis or a history of nasal polyps are at greater risk.

    Acetaminophen is the recommended pain reliever. As some one who just went through an emergency appendectomy, I would hate to see the combo drugs taken off the market. They made the recovery bearable.

  2. Voolfie says:

    Once again, a government of Don Quixotes is attempting to keep even the dumbest of us safe from everything that could possibly hurt us – no matter how much the non-stupid suffer in the process. It is truly a wonder that we are still permitted firearms, alcohol and cigarettes. And of course, regulators are not prohibitionists, right?

  3. georgeh says:

    Vicodin is just hydrocodone with tylenol added. The same of true of Percocet and oxycodone.
    Many doctors already prescribe the cheaper and equally effective generic hydrocodone or oxycodone.

    There never was a really good reason beyond marketing for combining either with acetaminophen.

  4. Denise says:

    You can add one more group who can’t take vicoprofin; people who are “allergic” to aspirin and NSAIDs. I put allergic in quotes because it is not a true allergy, but rather a hypersensitivity to aspirin.

    I’m one of those people. If I take ibuprofen or aspirin, my lips and throat swells up. There is a real risk that my throat will close. Needless to say, I avoid aspirin and related drugs (most pain killers and anti-inflammatory agents).

    Now that Nanny, er government, is in the process of destroying the acetaminophen market, I will just have to suffer should I have any serious dental work, operations, or whatever else that comes down the pike.

    Thank you FDA, thanks a whole hell of a lot.

  5. Robert says:

    If it were up to the feds, the only relief we’d get from pain is our doctor telling us “Walk it off, ya pussy.”

  6. ParatrooperJJ says:

    Personaally I prefer the narcotic by itself, less chance of liver toxicity.

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