I’m on Tylenol 3 with codeine. I’ve used it daily since the horrifyingly botched L-rods surgery in 1991 left me in serious pain. I try not to complain, and keep taking the codeine on my schedule to keep the persistent bone pain under control. I’ve been reluctant to go to heavier narcotics, I need to keep my liver healthy, and when they put me on methadone in ’93, I would fall asleep in front of friends and family. Bad idea.
Recently, the FDA advisory committee met to issue some recommendations source) and are “the most common cause of acute liver failure in the United States.” (source) This is especially true for chronic pain patients; about 42,000 Americans annually have to go to the ER with acetaminophen overdoses, half of which are accidental, and of those unintentional overdose patients with liver failure in the US Acute Liver Failure Study Group’s study, 81% had acute or chronic pain and 63% were taking a narcotic-acetaminophen combination chronically (source). The advisory panel ultimately voted on eleven proposals and passed nine, thus formally issuing those recommendations to the FDA. The recommendation that’s created the most buzz in patient and doctor circles is this one:on acetaminophen products, which are “estimated to cause about 450 deaths per year” (
Question 7: Do you recommend eliminating the prescription acetaminophen combination products?
Vote: 20 yes (10 saying this was a high priority); 17 no
This has been interpreted and widely reported as “FDA advisers vote to take Vicodin, Percocet off market.” Thanks for the misleading reporting CNN! You’ve freaked out patients and raised serious concerns among doctors. Yes, Percocet and Vicodin (the most commonly prescribed drug in the United States) are narcotic-acetaminophen combinations, but that doesn’t mean they’ll be gone; they could re-introduce them without the useless acetaminophen, perhaps renamed. There will always be effective narcotics available for chronic pain patients.
This recommendation won’t take Hydrocodone, Codeine and Oxycodone “off the shelves,” it’ll just remove the acetaminophen from them. For severe pain, the acetaminophen is like trying to defeat Godzilla with a biplane, pretty pointless to begin with! Why has the FDA required that drugmakers compound any opioid medications with other drugs anyhow? Chris at stationstops.com explains it thusly:
Up until now, the FDA has prohibited Hydrocodone (the opiate in Vicodin), from being sold in the United States *unless* it is combined with another drug as a compound – far and away, Acetaminophen being the most popular (and most dangerous).
The question is why did the government insist that, unlike the more powerful opiate Oxycodone (which is available standalone, as Oxycontin), Hydrocodone not be prescribed by itself?
From my amateur research around the net, the answer seems to be some unusually sinister legislation originating from The War On Drugs.
In some patients, Hydrocodone can be habit-forming, and its a popular drug of abuse. The FDA wanted to make sure there was something else in the drug that people *wouldn’t* want to take too much of to discourage abuse.
Its been known since 1970’s that too much Acetaminophen causes the unwanted side effects such as stomach upset and liver damage. So the FDA figured if that was in there too, people wouldn’t want to take too much of it.
Basically, for all intents and purposes, the FDA made an important and popular drug more harmful to discourage abuse.
Besides the fact that this was completely unethical and has probably resulted in the unnecessary liver damage and deaths of countless Americans (the vast majority legitimately ill patients to begin with), there is yet one more irony to this approach:
Many Vicodin users and addicts likely have no idea whatsoever that the government put Acetaminophen in there in the first place, nor what the reason and consequences of the Acetaminophen component are.
In other words, instead of being dissuaded from abusing the drug as intended, most Vicodin users were likely just thoughtlessly destroying their liver.
The government needs to rethink this absurd and harmful policy. The large amounts of acetaminophen consumed incidentally by chronic pain patients like me who take a lot of “compound” medication has (at best) marginal clinical value, and carries unreasonable risks. I’ve never benefited from mass quantities of acetaminophen. It’s easy enough to strip the acetaminophen from these meds, leaving only the opioids, and doing so won’t harm anyone. In my opinion, that’s seriously overdue. The FDA should act, though the narrow vote on this particular recommendation leaves that uncertain.