A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.  
 
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.  
 
OH HELL NO
acetaminophen
Novelhead: "...More than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.  
 
In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500."  
 
 
So, everyone who used to take one 500 mg pill will take two 325 mg pills, and get 150 mg more.
crataegus: I guess I'll take cruise vacations to score Acetaminophen now.
aktaeon: I believe the thinking goes along the lines of "people are going to double or triple whatever size pill we put out, so lets put out a smaller pill."  
 
People should be responsible and informed. They aren't. They harm themselves and their children.  
 
This group was asked to decrease the number of people harmed. Do you really believe this is that ridiculous of an idea?
Novelhead: Tylenol is one of the safest drugs there is. This safety discussion is insulting and infantilizing. Worrying about making Tylenol safer is like asking everyone who climbs a ladder to wear a helmet in case they fall down and go boom.  
 
aktaeon: Infantilizing? Really? Did you read the article?  
 
I agree that 400 deaths out of a 300 million population isn't some overwhelming number. But, it's more than one a day. And, the larger danger is liver damage.  
 
They're not talking about limits on how many you can take, they're talking about how the drugs are packaged, combined, and labeled.  
 
Compare the reasoning behind this to that of drug prohibition or blue laws.  
 
I think you're taking kind of a niche position. You guys are on kind of a "all government is bad" roll today.
FoolProof: It should be sold in powder form and snorted. Everyone will have to grow an aspirin nail.
XIV: I snorted aspirin once on a dare back in HS. Word to the wise...don't.
aktaeon: It wouldn't be an aspirin nail, it would be a percocet or vicodin nail. One of the two drugs being banned.
FoolProof: All the nails on your left hand, then.
blackvelvetjesus: Here's the FDA's page for the advisory panel, 2009 Meeting Materials, Drug Safety and Risk Management Advisory Committee.  
 
You can see the results of the voting, and the proposed roster of attendees with contact information.  
 
Wall of text to follow soon.
blackvelvetjesus: Acetaminophen is the only non-opoid pain reliever I can think of that has no anti-inflammatory effect. It's a well targeted drug, acting as an an anti-pyretic and analgesic. Acetaminophen is also the safest pain reliever on the market today. It doesn't affect blood coagulation like Advil-type drugs (non-steroid anti-inflammatories) or aspirin, it doesn't damage your kidneys, and it's about the only safe pain reliever to take during pregnancy. Acetaminophen is also the go-to pain reliever for kids, because it doesn't upset your stomach. There's just no reason for the FDA to push back even further on the drug beyond the warning labels they already mandate.  
 
From the advisory panel's meeting agenda:  
The mechanism of liver injury is not related to acetaminophen itself, but to the production of a toxic metabolite. The toxic metabolite binds with liver proteins, which cause cellular injury. The ability of the liver to remove this metabolite before it binds to liver protein influences the extent of liver injury.
 
The metabolite unnamed is NAPQI (N-acetyl-p-benzo-quinone imine). 5-15% of acetaminophen ends up as this metabolite in the liver, but NAPQI is readily handled by the amino acid chain glutathione. All cells in the body can synthesize this amino acid, but it occurs primarily in the liver. The body is well equipped to deal with NAPQI, and the liver of a normal, healthy person has a large reserve of glutathione and other thiols to deal with toxins.  
 
You can read about acetaminophen metabolism in the liver from the article, Acetaminophen, in the book Goldfrank's Toxicological Emergencies.  
 
I won't post all of the questions the committee voted on. There's nothing particularly surprising there, considering similar committees in the past have recommended things like regulating pseudoephedrine as a means of controlling methamphetamine production. It is interesting though that, intending to reduce incidents of acetaminophen toxicity, the committee recommends reducing maximum doses, and making 500mg doses prescription only. Consumers seeking the same efficacy from OTC doses of acetaminophen will have to take more pills, increasing excessive dosing. If the committee considers consumers too ignorant to follow dosing instructions, mandating smaller doses will not make things better.  
 
As for recommending a ban on combined opoid-acetaminophen drugs, I have to award the Sippy Cup of Shame to the committee.  
 
From the NYT article:  
Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).  
 
“It ties the doctor’s hands when you put the two drugs together,” said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. “There’s no reason you can’t get the same effect by using them separately.”
 
Presumably, the doctor in question went to medical school, and knows that there are other drugs out there than Percocet and Vicodin. A doctor can in fact just prescribe acetaminophen, or the combination drugs, or go further and prescribe hydrocodone or oxycodone, which are the opoids in Percocet and Vicodin. The doctor's hands aren't tied. The array of drugs available in USP is pretty staggering. Doctors that prescribe Percocet or Vicodin are normally erring on the side of caution, by not prescribing pure oxycodone or hydrocodone, putting their patient at greater risk of developing a tolerance to opoids, but a dependence as well. Vicodin and Percocet are often the more responsible choices.  
 
Dr. Fishman seems to presume ignorance on the part of the practitioner. If Dr. Fishman's logic is the prevailing thinking among the YES voting members of the committee, expect some heavy regulation.  
 
The pharmaceutical industry has made acetaminophen safe and effective. It's unfortunate that in some rare cases people suffer toxicity because of thiol deficiencies. It is more unfortunate that other individuals suffer toxicity because they do not follow dosing instructions or heed label warnings. This is not sufficient reasoning to regulate a safe and effective drug, or to eliminate combined opoid drugs from the market.  
 
I'm pulling for Johnson & Johnson's and Abbot's lobbyists on this one.
Darwish: That's a bunch of bullshit.
Darwish: [/angryfilter]
blackvelvetjesus: Quiet you, or I'll release the dogs, or the bees, or the dogs with bees in their mouths and when they bark they shoot bees at you!!
aktaeon: Fair enough. I still object to the trivial dismissal of the issue.  
 
"If the committee considers consumers too ignorant to follow dosing instructions, mandating smaller doses will not make things better." What evidence is there of that claim?  
 
At 500mg, eight pills is 4g. At 325, twelve pills is 3900. Some people are deliberately overdosing, there are probably some that aren't. What percentage are they?  
 
If someone was regularly taking two pills instead of one pill, they'd be reducing their intake by more than a third moving to a smaller dose. If they add an extra pill to compensate for the smaller dose, they're still going to come in short of a full gram per administration. Even if a person taking only one pill per administration doubled to compensate, they could take six admins of two doses and still be within current guidance.  
 
I'm not ignoring your point. I'm suggesting there might be other dimensions to the issue, maybe a psychological aspect that at least a few doctors aren't outright dismissing. This doesn't look like an amputation to me. It looks like a small change. You make a minor adjustment and review the results. Things get better over time.  
 
I don't understand this all-conservative all-the-time, no-changes, no-tinkering, industry-is-god, all-hands-off, Johnson&Johnson-has-your-best-interests-at-heart-and-always-has, status-quo-is-the-best-there-is thing.
blackvelvetjesus:
Fair enough. I still object to the trivial dismissal of the issue.
 
I don't want to give the impression that I have a flippant attitude about those who've had serious complications from or fatal reactions to acetaminophen. The low number of illnesses and fatalities seems to indicate that acetaminophen is being used correctly by most consumers, and that most consumers are not easily susceptible to acetaminophen toxicity. If I have a poor attitude, it's toward the committee, which may detract from this discussion.  
"If the committee considers consumers too ignorant to follow dosing instructions, mandating smaller doses will not make things better." What evidence is there of that claim?
 
I have no evidence linking that claim to any statements from the committee. I attempted to qualify that statement by saying "If", but I can see how the sentence could come off as a declaration of fact. I didn't find the minutes or transcript of the meeting anywhere, so I had to reconcile the committee's intent of reducing illnesses and fatalities from acetaminophen toxicity, with their recommendations to curtail doses and enhance labeling requirements. Given that some of the illnesses and fatalities were due to medical complications that are no one's fault, and the remainder are due to deviation from dosing instructions and warnings, the committee's recommendations read to me as another place for the government to be our nanny. The changes won't do a thing for those with medical complications who unknowingly do harm to themselves, and changing doses and making bigger warnings on packaging won't really change the behaviour of people who already ignore them.  
At 500mg, eight pills is 4g. At 325, twelve pills is 3900. Some people are deliberately overdosing, there are probably some that aren't. What percentage are they?
 
Not a clue. I'm still reading the white papers that the committee posted here. The paper from the Rocky Mountain Poison and Drug Center shows some interesting studies on the safety of acetaminophen in test groups. However, I'm still looking for usage data gathered from patients with reported illnesses or fatalities against typical usage.  
If someone was regularly taking two pills instead of one pill, they'd be reducing their intake by more than a third moving to a smaller dose. If they add an extra pill to compensate for the smaller dose, they're still going to come in short of a full gram per administration. Even if a person taking only one pill per administration doubled to compensate, they could take six admins of two doses and still be within current guidance.
 
To me, you've illustrated that changing dosage size would be an ineffective policy. That's why the committee's recommendations aggravate me. If the intent is to encourage those who dose excessively to moderate, they have ignored the tendency for everyone, especially those dosing excessively, to self-medicate. The FDA has a bug up their ass about acetaminophen from what I've read so far in their white paper, Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity.  
I'm not ignoring your point. I'm suggesting there might be other dimensions to the issue, maybe a psychological aspect that at least a few doctors aren't outright dismissing. This doesn't look like an amputation to me. It looks like a small change. You make a minor adjustment and review the results. Things get better over time.
 
I'm inclined to agree that the recommendations towards acetaminophen-only products are minor; the pointless nature of those recommendations is what frustrates me. The recommended banning of opoid-acetaminophen drugs is what really set me off, because those drugs are an excellent median for doctors to avoid prescribing full opoids.  
I don't understand this all-conservative all-the-time, no-changes, no-tinkering, industry-is-god, all-hands-off, Johnson&Johnson-has-your-best-interests-at-heart-and-always-has, status-quo-is-the-best-there-is thing.
 
I think less hyperbole and more discussion will contribute to mutual understanding.
aktaeon: "I think less hyperbole and more discussion will contribute to mutual understanding."  
 
It isn't just hyperbole. Read back through this discussion. Read the article and the other doctor's comments again. Is 500 mg really super magical? What is the pure mathematical proof that makes 500 mg so perfect, so absolutely right and true, so immutable and godly that if you change it you've done something pointless?  
 
How many people have to be prescribed these drugs? How many of them over the course of their lives develop liver problems related to acetaminophen.  
 
Is there a crystal ball that says all things are perfect as they are now? If medicine were not a clown bastard of science, and if there were tests for which patients would react poorly then this discussion wouldn't be necessary. But, the way I see it, we got where we are today by making a change and recording the results.  
 
Why now? What makes now the right time to stop tinkering?  
 
What, I mean Jesus fscking forbid, what if they make this change and the number of people getting liver damage goes down? What if it goes up? What if they make another change? What if over time we discover the behavioral aspects related to a safe drug like this and can apply what we've learned here to less safe drugs?  
 
If there are enough doctors researching how to keep morbidly obese neocon talking heads erect so they can go on vacation in countries with active child sex industries, I think there's enough breathing room for this change.  
 
Having watched the withering ancient walk out of pharmacies with hefty bags of prescription drugs, I'm suspicious of these dissenting doctors opinion that patients will be unable to cope with taking both the opioid and Tylenol.  
 
And, I'll take your sippy cup award if it allows me to not fall in with the magical-thinking crowd.
FoolProof: I thought *I* was The Clown Bastard of Science. :(
FoolProof: ... Is 500 mg really super magical? ...  
 
Very fair.