FDA Panel Votes to Eliminate Vicodin and Percocet

Right now regular strength dosing around the clock is 650mg q4 hours (3900mg/day), and the extra strength dosing around the clock is 1000mg q 6h (4000mg/day). They are nearly equivalent.

Is the recommendation to reduce the 650mg dose to q6 hours? If not, the 4g max is only slightly decreased, and patients won't make the mistake of taking ES at the same rate as RS. It shouldn't be called extra-strength anyway--it should be called "less-frequent dosing"

From what I remember reading the whole intent was to reduce the 4gm dose/24 hrs and to get rid of OTC tylenol ES and made it Rx only & get rid of the combo drugs (vicodin/percocet). BUT the panel didn't say what to reduce the 4gm/day to....so that would really be the key and the rest would fall out from there I would guess. There is another thread on this same topic "OMG no vicodin or percocet"

As a medical transcriptionist, I flag reports many many many times a day that contain prescription errors. Just today I had one in which the physician dictated an order for a patient to receive 400 mg of Valium. Anytime you involve a human being, there are going to be errors eventually.

My husband experienced a bowel obstruction secondary to his use of Vicodin. He used it as prescribed and was not abusing it. No one had said anything to him about needing to take a stool softener with Vicodin or the signs of bowel obstruction. Of course, the doctor who was prescribing it thim for 2+ months should have thought of this. Although constipation was listed as a potential side effect in the patient literature, it did not include the suggestions that the doctor should have passed along such as using a mild stool softener.

Did it say how many ODs were inadvertent?

I work with neonates... so no Vicodin or Percocet in my unit. But seriously, is inadvertent acetaminophen OD that common?

Sorry to hear about your husband's experience, however this is common. Time is the number one enemy facing all of us with discharge instructions or new medication instructions BUT it is the responsibility of the prescriber, the educator and the pharmacist to advise prior to handing that patient a prescription for anything that may be detrimental to their health.

This is not just about pain killers, I have been on a role about hypertension meds because I had a run of CVA patients who swore to me they really didn't understand the disease or the medications and their actions. I believed them.

The system is broken, patients are too trusting, we need to look at the health literacy level of every patient prior to discharge and teach THEM WHAT THEY NEED based on their abilities and make sure they follow up so that evaluation of progress can be made.

How many CVAs, DKAs, diabetic comas, chf exacerbations, and a myriad of other problems are caused by lack of or insufficient patient education? I'd bet alot....if the FDA, and or our legislators want to involve themselves they should attempt to help with this problems.

From the philadelphia paper:

"
It is one of the world's most popular drugs, considered safe to treat fevers in children and aches and pains in pregnant women.
But yesterday, the U.S. Food and Drug Administration took action aimed at making consumers more aware that acetaminophen, best known as the Johnson & Johnson drug Tylenol, can be as hazardous as it is ubiquitous.
An FDA panel of outside experts voted, 21 to 16, to lower doses of acetaminophen because it can cause liver damage.
The advisory panel recommended decreasing the maximum daily dose to 2,600 milligrams from 4,000 milligrams. A single pill of a medication such as Extra Strength Tylenol is 500 milligrams.
The FDA cited research showing that acetaminophen overdoses led to 56,000 emergency-room visits, 26,000 hospitalizations, and 458 deaths from 1990 through 1998.
Some overdoses were suicide attempts, but many were accidental and happened because patients took more than one product containing acetaminophen, an ingredient in products ranging from NyQuil to Kosher Care Pain Relief.
The FDA panel also recommended banning the prescription painkillers Percocet and Vicodin, both of which contain acetaminophen.
Endo Pharmaceuticals Holdings Inc. of Chadds Ford makes Percocet. The company plans to work with the FDA to find a way to keep the drug, which brought in $129 million in sales last year, on the market, Endo spokesman Kevin Wiggins said.
Abbott Laboratories of Illinois makes Vicodin.
The FDA is not required to follow the advisory panel's advice, but it usually does. It is not clear when the agency will issue its final decision.
The panel also voted to make the 1,000-milligram dose of acetaminophen available only by prescription.
U.S. consumers spend $2.6 billion yearly on 28 billion doses of products containing acetaminophen, the FDA said, citing data from IMS Health.
McNeil Consumer Healthcare, the Fort Washington unit of Johnson & Johnson that makes Tylenol, said in a statement that it disagreed with the panel's decision.
In its statement, McNeil said it worried the vote would lead consumers to use other pain relievers, which have their own risks. Alternatives such as aspirin can cause gastrointestinal bleeding, for example.
"The safety and efficacy of acetaminophen has been established in over 150 clinical studies and is supported by over 50 years of clinical use," McNeil said.
Cesar Alaniz, a clinical pharmacist and associate professor at the University of Michigan, said that the drug was safe at recommended doses, but that his research showed that consumers were ignorant about how to use it safely. "The problem is that not enough of the public knows what a potential toxic dose is," he said.
He was coauthor of a study that looked at 128 adult patients who overdosed on acetaminophen. About 60 percent of those overdoses were intentional. Among those who took too much acetaminophen by accident, many had chronic back or migraine pain.
"They had debilitating pain and out of frustration take too much acetaminophen," Alaniz said.
In another study that he coauthored, 104 patients visiting a general internal-medicine clinic run by the University of Michigan Health System said they had used acetaminophen in the last six months, but almost none could identify the maximum daily dose of either regular or extra-strength preparations of the drug. Nearly 70 percent of patients underestimated maximum doses.
The FDA panel's recommendation to lower doses made sense, Alaniz said.
"You don't really ever know for sure whether you need to take higher doses," he said, "so if you can relieve a headache with one tablet, that's better than two."
The connection between acetaminophen and liver damage has been on the FDA's radar screen for years. The consumer-advocacy group Public Citizen has been pushing the FDA to reduce recommended doses of the drug since at least 2002.
Sidney Wolfe, director of Public Citizen Health Research Group and a member of the FDA panel that voted yesterday, said a similar panel first had recommended adding a warning about the risk of liver damage to labels of drugs containing acetaminophen 32 years ago.
The FDA finally insisted on those warnings in April, a precursor to yesterday's recommendation on dosage.
Wolfe said that he wasn't sure why the action had taken so long, but guessed that industry pressure on the FDA had played a role."

http://www.philly.com/inquirer/local...cmpid=15585797

The system is very broken. While working in MT I see a different side of it than a working nurse does and when I worked in rehab I saw even a different side. I have seen different problems in both areas of healthcare that I have worked in.

I don't know what the solution is, but I know that each of us would benefit if we could somehow return to the days when healthcare professionals had a few moments to stop and look a patient in the eye and weren't so rushed that they forgot vital information. The only thing that I know we can do is to do the very best job we can as healthcare professionals and also be responsible patients and not leave our lives and our health to be the sole responsibility of the person who hands us the pills. Sure, that probably won't happen but I can dream!

I know a lot of patients complain about the doctors who evaluate them with their nose buried in the computer. I don't think that a lot of doctors like that either! It's the darn ERM and they have to sit there and put in the information. Are these things steps forwards or steps back? I suppose it depends on how you look at it and even what day you look at it on.

Well now that article makes more sense.

Eliminating Vicodin and Percocet for the risk of acetaminophen OD isn't going to solve any problems.

NOT per year! So sorry. This was over several years. Sorry sorry. That's what happens when I'm half listening to the radio....

I don't know if a public eduational campaign about the dangers of too acetaminophen will help all that much with this problem. After all, we have been bombarded with "awareness" campaigns against smoking, but millions of people still chose to smoke. The same with drunk driving and not eating a diet high in fat/cholesterol, for instance.

There are still people out there who will chose to take too many pills that they shouldn't take, even if their doctor/pharmacist/drug label or ad campaign tells them not to.