The end of Vicodin?

| Comments (7) | Pharma
The standard first-line opioid painkillers, Vicodin and Percocet, are actually both combination medications containing an opioid (hydrocodone for Vicodin and oxycodone for Percocet) with acetaminophen. The theoretical advantage here is supposed to be that you get better pain suppression with the combination than with either alone. The disadvantage here is that acetaminophen has a relatively narrow therapeutic index, and overdoses cause acute liver damage. [I suppose there's an argument that this is an advantage, since it makes it hard to get enough opioid to get high without risking liver damage.] According to Wikipedia, acetaminophen poisoning is the most common cause of acute liver failure [*].

Because of concerns over liver damage, the FDA's Advisory Panel has recommended eliminating them:

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, "The F.D.A. will make a final determination and Abbott will follow the agency's guidance."

The question I have is what will replace these meds in common use. There appear to be a number of combination hydrocodone formulations (with aspirin, ibuprofen, chlorpheniramine, ...), but with the first two you need to worry about allergies and chlorpheniramine doesn't have any painkilling effect so you just have to accept the unnecessary antihistamine side effects. I'm not sure if there are any hydrocodone-only formulations—I've never been prescribed one. While there are oxycodone-only formulations, doctors typically start with vicodin and then move up to percocet if that doesn't work, so it's not clear what this does to the front line. Moreover, as I said earlier, if you prescribe non-combination formulations you need to worry more about abuse, since there's nothing stopping the patient from just upping the dosage.

Obviously, preventing people from overdosing is an important consideration, but we also need to make sure we have a solution for pain that doesn't respond to OTC medications (NSAIDs and acetaminophen).

7 Comments

I've been prescribed hydrocodone as a stand-alone drug; it makes me violently nauseated, so it is pretty useless to me, but I know it is available.

The oxycodone-only formulation is worth a fortune on the street where I live. They grind it up and inhale it. You can get $10 a pill for Percocet, but it gives a less potent high (and is also slightly less addictive) because of the acetaminophen.

What I don't get is why combination acetaminophen drugs are thought to be doing significant harm while OTC pure acetaminophen isn't.

The oxycodone-only formulation is worth a fortune on the street where I live. They grind it up and inhale it. You can get $10 a pill for Percocet, but it gives a less potent high (and is also slightly less addictive) because of the acetaminophen.

What I don't get is why combination acetaminophen drugs are thought to be doing significant harm while OTC pure acetaminophen isn't.

I'm assuming that the reason why plain acetaminophen isn't considered as dangerous as acetaminophen plus oxycodone is that the former comes without the potent psychopharmacological incentive to take it in liver-damaging quantities.

The natural next question: if people getting high on Vicodin or Percocet end up taking enough to destroy their livers, then won't taking away the acetaminophen simply allow those same people to ramp up their dosages until they end up taking enough opioids to destroy their nervous systems?

So they want to ban these painkillers because they are bad for the people who are addicted to them?

Is that right?

If you read the remainder of the article you'll see that the
committee also wants to reduce the maximum dosage of acetaminophen
in a single pill to 325mg (currently it's 500mg), so I don't
think it's true that pure acetaminophen isn't doing significant
harm. Rather, there are substitutes for combination opioids but
no adequate substitutes for pure acetaminophen for people who
have a bad reaction to NSAIDs.

WRT Dan's point, probably some people will respond to the removal of acetaminophen by ramping up their dosages, however, opioids really aren't that
bad for you, even in very high doses. And while addiction is
no picnic, it's probably nowhere near as bad for you as having
your liver totally destroyed. To quote House, "You can't live without
a liver."

Big problem is when taking multiple medications that are doped with acetaminophen. Particularly when the dosing schedules aren't the same. some are 4hr, 6hr, 8hr meds, some as needed. That's when it gets particularly challenging to calculate the actual real-time load on the liver. I'm all for them pulling the combo drugs and letting the doc and patient come up with the actual combination of these medications thats right for their particular situation.

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