Behind the Govt.'s Idea to Pull Vicodin and Percoset from the Shelves: Is Tylenol to Blame?

Why are Vicodin and Percocet packaged with acetaminophen in the first place?

So the news is out, the bell has sounded: Vicodin and Percocet may soon vanish, no longer to aid wisdom-detoothed adolescents in finally really getting Nirvana. A panel of grave-faced doctors with expertise, wisdom, and beards decreed it so.

But the pill-pulling isn’t even due to the addictive aspects of the drugs,  which stem from the inclusion of synthetic opiates; it’s the fact that the medications also incorporate acetaminophen, better known under its ubiquitous brand name, Tylenol. (in fact, the pill-pulling isn’t even as guaranteed as it seems; although the NYT expansively asserted that the FDA “is not required to follow the recommendations of its advisory panels, but it usually does,” the 20-17 voting margin hardly rings of consensus, and the Faster Times spoke with a panelist who voiced some reservations about the way the vote was conducted.) Tylenol can cause acute liver failure in doses over 4,000 mg/day, a dose that is fairly easy to reach with prescription opiates in cases of chronic pain management or addiction.

And so with classic media panache, the fact that the something in your medicine cabinet WILL KILL YOU! was eagerly explored in myriad outlets, and immediately followed by measured reassurances that it’ll all be okay that we would’ve taken to heart if we weren’t already in the hospital dying from NyQuil and a lifelong Smartie-smoking habit. But all of this begged the question: why are hydrocodone (Vicodin) and oxycodone (Percocet) packaged with acetaminophen in the first place?

The first and most simplest reason is that acetaminophen has what Dr. Fancywords calls an “opioid sparing effect.” That is to say, Tylenol in the system causes opiates to exert a stronger influence, i.e. do more pain killin’. This means lower doses of the opiate are needed, and, natch, too much opiate-eating can make you really really want even more opiates (and also stop pooping, which can be more or less important, depending on how much you like pooping). So this would make the Tylenol seem like it should make Vicodin or Percocet safer—but this is only true if the doses remained as effective day after day, and this isn’t always the case.

The process of tolerance, even if slowed by this opioid sparing effect, often does still build at standard medical doses. With typical acetaminophen content being around 500mg per Vicodin or Percocet pill, a mere 8 pills exceeds the toxicity threshold. Munching them two at a time, all it takes is one insomniac night for you to put yourself in danger. Yes, this would mean violating your physician’s instructions, but find me a person who has always obeyed physician instructions to the letter on every drug they’ve ever taken, and I’ll show you someone who alphabetizes their underwear drawer.

So then why not separate the two drugs? This would probably be the short term effect of the FDA panel’s recommendation, if it’s put into full effect. Pain patients could receive one prescription for hydrocodone/oxycodone, plus a good old Tylenol bottle. However, we’re confronted with another intrinsic human weakness: following the fucking directions.

Entire studies are conducted devoted to the issue of drug regimen adherence, i.e. how reliably people take the drugs they’re told to take, and if they take them the way they’re supposed to. Although it seems less so every year, popping a pill doesn’t have the sense of biological urgency attached to it that things like eating, boinking, and watching Lost do (the luckiest among us eat, boink, and watch Lost ALL AT THE SAME TIME, and we will crush them when the revolution comes). A basic message from almost all of these studies is that adherence, already a dodgy thing, drops off precipitously the more different pills are involved. Which eliminates any benefit from an opioid sparing effect—making addiction more likely and increasing tolerance at an even faster rate than would occur with good old “Vike” (that’s a street name!).

But there’s another reason to keep acetaminophen around. The universe of U.S. government pharmaceutical oversight is, like a Philip K. Dick theology, ruled over by a generally benign, protective force known as the FDA, and a largely dark, insane deity known as the DEA. The ease by which a drug can be prescribed by a physician and picked up by a patient is determined by its placement on the Drug Enforcement Agency’s drug schedules. Schedule IV drugs are the least regulated; Schedule I the most.

When combined with Tylenol, hydrocodone is a Schedule III drug (the same thing goes for codeine, but not, oddly, for oxycodone, which is Schedule II whether or not it comes with Tylenol. That phrasing, with the comma-oddly-comma, tends to apply to a great number of things the DEA does. We hope to go into this in more detail soon. Journalisticness-ier!). Schedule III drugs just need a prescription and can be refilled by mail, in three-month quantities, all that good stuff. Hydrocodone alone, however, is a Schedule II drug, meaning prescriptions can’t be for more than a month, all prescriptions must be written and verified, and the physician must be registered with the DEA and file reports and generally do a lot of things that involve suspecting the patient instead of treating them. For patients with chronic pain (not to mention chronic pain that varies in intensity, requiring different doses day to day) and limited physician access, a lower-scheduled drug can spell the difference between misery and an almost normal life.

(now is when we would normally rant about how a better health care system with lessened paperwork loads, better physician reimbursement, and easier patient access to physicians would allow more personalized and flexible treatment regimens. This would solve a lot of problems and make drug schedules so much less important. But America is in a crisis and every blogger must do her or his share, and therefore we would ask you to forgive the glaring omission and maybe provide your own rant. If only there were some field below this one for a reader to go off about whatever shiny thing is in front of them at the moment)

So this raises another question: why would the DEA loosen regulations on a variety of opiate pills that could be more dangerous? Although there’s some merit to the idea that the lower doses of hydrocodone required when accompanied by acetaminophen making the whole pill less pop-worthy, the fact that tolerance still develops clearly indicates the processes that lead to addiction are underway, mixed formula or no. And anyway, if Tylenol had any effect on reducing abuse, why would the DEA dedicate whole webpages to wigging out about recreational Vicodin use?

Is it possible, then, that the DEA is banking on the threat of liver failure to dissuade users? We hope not, although we’ve spoken with physicians who suspect that this is what’s going on (and graciously offered to share their tinfoil hats with us); if that is the reasoning behind the Vicodin being less regulated than pure hydrocodone, then the end effect is punitive—if you’re a user, you deserve it. At the very least, there’s a cruel double standard across government agencies, since the threatened elimination of the cocktail is a paternalistic response to non-abusers inability to use Tylenol-containing products safely. And users aren’t known for their diligent pre-use research. So the FDA ends up saying, “We don’t trust you not to die,” while the DEA’s message is, “We don’t trust you. Die.”

But regardless of the philosophical intention, the end result of the scheduling is that either way someone gets hurt; either Vicodin is eliminated and pain patients experience a decrease in quality of life , or the FDA takes no regulatory action both patients and abusers experience a decrease in, um, life. Both of which are what drugs are supposed to enhance in the first place.

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