in prescribing

Less Tylenol

They’re changing Vicodin. According to the FDA, it’s got too much Tylenol (acetaminophen) in it. So they’re going to “fix” it.

Combination drugs containing hydrocodone and acetaminophen like Vicodin, Lorcet, Norco and similar generics are incredibly popular for treating pain. They’re typically used in treating acute post surgical pain, ideally for short term use. Since 2007 the use of these drugs in patients 60 years and older has increased 32%. In other words, these medications are being used for chronic pain conditions more now than ever before. Some are lobbying the FDA to outlaw the use of these drugs to treat chronic pain, presumably because of their “habit forming” qualities as well as the toxicity of high doses of acetaminophen.

The FDA is requiring that these combination drugs be reformulated using less acetaminophen by January of 2014. The most common formulations right now are Vicodin 5/500 (acetaminophen/hydrocodone), Vicodin ES (7.5/750), Lorcet 10/650, or Vicodin HP (10/750) The maximum “safe” dose of acetaminophen is 4 grams or 4000 milligrams per day, with no more than 1 gram (1000 milligrams) in a dose. Some have questioned if even these safe levels are too high due to the effect of acetaminophen on the liver. In high doses, acetaminophen is toxic to the liver. Every label of every product that contains acetaminophen is required to explain this in detail. The problem is, most folks don’t read the label.

It’s likely that this “overdosing” of acetaminophen is of two types. The first type is from ignorance. Many cold remedies and over the counter pain formulations contain acetaminophen and consumers don’t realize it. If someone has the flu, they may take a flu remedy with acetaminophen as well as a Tylenol to bring down a fever. This can inadvertently cause an acetaminophen overdose.

The second type of acetaminophen overdose comes from those who are abusing the drug. Hydrocodone is an opiate drug like codeine, morphine and heroin. It can cause intense euphoria and is used by many to get high. Someone who uses opiate medications often, whether for pain or for recreation, will become tolerant to the medication. Tolerance is the tendency to need more of a drug to get a similar effect from the drug. This is very common in abused drugs, but also happens with many  “non-abusable” drugs.

People who use combination drugs to get high are at high risk for serious liver damage. Once you’ve gained a tolerance for the medication, you’re going to use more or you’ll go into withdrawal. Some make the argument that keeping the acetaminophen amounts high in these medications will discourage addicts from taking too much. Personal experience tells me that someone who has become dependent on an opiate medication is usually not making decisions based on liver toxicity. They’re trying to avoid being sick from withdrawal.

We know now that we need to be more aware of potential acetaminophen overdoses. So what’s the solution? I have a couple thoughts:

  • read labels: If we could count on people to read the label we wouldn’t see so much accidental liver toxicity. So patients need to be told explicitly that the medication they’re receiving had acetaminophen in it by you and your staff. Along with explaining it verbally, it probably need to be explained in writing. Post op instructions that can be reviewed after the fact or on a website would be a great place to explain this again. It’s probably worth making sure the patient knows that they need to read every label of over the counter medications to be sure of what they’re taking. (duh)
  • do the math: If you’re doing a procedure where you think it’s appropriate to prescribe a combination drug like Vicodin, make sure you do the math for the patient. Explain that the patient should not take any more than x tablets of a medication per dose and no more than x doses per day.
  • smaller doses: With the new FDA changes, combination drugs will have no more than 300mg per tablet. But in the mean time, I would prescribe Lorcet 10/650 with instructions to take half a tablet. The tablets are scored to be broken in half so it’s more like prescribing a 5/325 dose.
  • avoid acetaminophen: Let’s face it…dental pain is almost always inflammatory in nature. Acetaminophen isn’t an antiinflammatory. We’ve got better options. Even if you want to prescribe an opiate. Vicoprofen is generic now, so you can prescribe a 7.5mg hydrocodone/200mg ibuprofen dose on a generic cost basis. Even better is a newer medication (not generic yet) called Reprexain. It allows you to prescribe 200mg of ibuprofen with with either 2.5, 5 or 10mg of hydrocodone. I have to thank my friend Matt Ray for this info as I hadn’t heard of it before. This gives a doc a lot of options in prescribing for pain. Since I usually recommend taking acetaminophen along with ibuprofen this new medication gives a lot of flexibility.
In a perfect world our patients would be completely aware of what’s in every medication that they take and they would never mistakenly (or intentionally) take too much Tylenol. The same perfect world would be inhabited by awesome flossers that don’t drink alcohol and aren’t overweight. Since we don’t live in a perfect world it falls to us as doctors, to educate and help them manage pain and avoid medication toxicity.
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  1. This was an excellent post. My Father was a DDS! He practiced in Birmingham, Al for many years. Thank you for your all the education and training you endured to be able to help others.