FDA Clamp Down & Acetaminophen

FDA Clamps Down On Acetaminophen In Prescription Drugs

Narcotic painkillers Vicodin, Lortab and Percocet contain a potentially dangerous ingredient that most people rarely think about: acetaminophen.

That's right the same medicine sold separately as Tylenol is often combined with narcotics to make even more potent pain pills. But, as the Food and Drug Administration noted today, too much acetaminophen can ruin a person's liver.

So the agency is asking makers of prescription drug combinations that contain acetaminophen to limit it to 325 milligrams per pill, capsule or slurp of liquid medicine a person might take.

The drugs will also have to carry stern warnings about the dangers of acetaminophen overdoses for livers, something over-the-counter medicines already are required to do.

How big a factor is acetaminophen in liver failure? Well, the FDA cites a study from a few years back that found acetaminophen overdoses (about half of which were unintentional) were to blame for more than 40 percent of cases of acute liver failure examined over six years.

People can get into trouble taking too much of the painkillers or inadvertently taking the medicines along with other acetaminophen-containing remedies. The FDA's announcement includes a rundown of common medicines affected.

It's worth noting that Vicodin and generic versions (hydrocodone plus acetaminophen) are the most prescribed medicines in the United States, according to data from IMS Health. Pharmacists dispensed more than 128 million prescriptions for the stuff in 2009.
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Note: When used within proper dosing limits Acetaminophen (Tylenol) is the only painkiller recommended for person suffering with advanced liver disease (cirrhosis). 1000-2000mg daily for compensated cirrhosis (CPT class A or B) and about half that for persons with decompensated cirrhrosis (CPT class C).

Hectorsf

[Susan_1a_CC]

So glad that you posted this into.  I know that there are those who swear by Tylenol and I know that docs routinely say "oh, you won't be taking enough to do any damage,"  I say BS!  You never know when you're going to find yourself amongst the people who are taking Tylenol in recommended dosages and run into serious problems.  Don't believe that an OTC could really be so dangerous - than just google tylenol and liver and then make up your mind.  Tylenol wipes out glutathione and leaves your liver without its #1 defense.  This is an untold story but, than again, if aspirin were going for FDA approval today, it would likely be denied.  

[Kathy73]

When I was treating last year I had terrible headaches 24/7 as a sx. I was taking so much tylenol my GP got worried and first put me on vicadin and then, because of the amount of tylenol in that, put me on Norco. Norco has more of a ratio of opiate to tylenol. It worked for me. After I finished tx my GP weaned me off the Norco.

I went through almost four months of constant headache, getting a brain scan, etc. to make sure nothing was going on there, before my GP gave me the vicodin and then the norco. My hepatologist couldn't be bothered. I wouldn't have been able to continue tx and ultimately have SVR (a year after tx) if it hadn't been for this miracle drug.

[mikesimon]

Note:

Note: When used within proper dosing limits Acetaminophen (Tylenol) is the only painkiller recommended for person suffering with advanced liver disease (cirrhosis). 1000-2000mg daily for compensated cirrhosis (CPT class A or B) and about half that for persons with decompensated cirrhrosis (CPT class C).

[nygirl7]

Honestly I cant imagine how many little Vicodins you would be taking a day to risk liver failure or something......

[Trinity4]

I took Tylenol throughout my entire treatment which was 1 1/2 yrs along with advanced liver disease and my most recent biopsy showed less liver damage than the first one so it can be too bad for you.

[mikesimon]

I believe one issue with Vicodin is that many people didn't know that it contained Acetaminophen and were taking additional Tylenol without realizing how much Acetaminophen they were taking. And we know some people just overdose on Tylenol without even knowing that in large quantities it's toxic.
I think labeling will do a lot and a lesser dose of Acetaminophen should make overdose less likely.

Mike

[Susan_1a_CC]

I know a lot of you swear by Tylenol, I don't.  And, I am not alone.  From:http://www.wellness.com/blogs/DrLauraMarkham/51/what-every-user-of-acetamino  

"Most parents think of Tylenol as a wonder drug -- harmless, readily available, and a miraculous cure for teething fussiness, ear infection pain, fevers and other childhood maladies. But when an old friend's son died recently from tylenol poisoning, I did some research. Call me naive, but I was shocked by what I learned."

Only had two minutes, but this info isn't hard to find.  We all take calculated risks, I just think that we should be informed of them.

[Susan_1a_CC]

From: http://www.eurekalert.org/pub_releases/2005-11/jws-iro112905.php

"Increasing role of acetaminophen in acute liver failure in the United States

Nearly half of all cases are unintentional

"Acetaminophen poisoning has become the most common cause of acute liver failure in the United States," report the authors of a new study in the December 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). While attempted suicides still account for many cases, almost half are the result of unintentional overdose."

So, I'm just saying... (and yes, there's way more info out there even though YMMV.)

[HectorSF]

I believe Mike's second post is an excellent summary of the article. As he said, many people are unaware of the cumulative dosage of acetaminophen they are taking, which can cause liver damage or failure. That is why the FDA wants the drug manufacturers to limit the amount of acetaminophen in their drugs.

Susan we are not saying acetaminophen is a harmless drug. Far from it. As with any drug it must be used properly to be effective and safe. What we are saying is that for persons with advanced liver disease (which is a small but important MINORITY of HCV patients that post here) the recommended analgesic for those persons is acetaminophen (when taken within the recommend dosages). This is the opinion of every hepatotologist that I know (and I know a handful) and is recommended by the AASLD. Other meds such as NSAIDs can cause GI bleeding (which can be fatal)and cause kidney in patience with decompensated cirrhosis.

That Dr.Laura Markham (who is a clinical psychologist, not a medical doctor of any sort) is surprised by the number of people that suffer from acute failure due to acetaminophen OVERDOSES (note: NOT within recommended dosage limitations) is probably due to the fact that she only knows what the average layman know about the damages of many over the counter meds.

I appreciate you saying that it is your personal opinion that "you don't swear by Acetaminophen (Tylenol). I don't think anyone here does, but for us with cirrhosis it is the only pain reliever we can take. It isn't much but at least it something that at times can help to ease the aches and pains we suffer from.

The reason I posted this article was to hopefully shed some light on this subject of Acetaminophen/Tylenol as it relates to the liver and liver damage as this topic seems to continually come up on this forum.

Sincerely,
Hectorsf

[Susan_1a_CC]

Thank you for explaining the perspective of those with cirrhosis and their appreciation of Tylenol - not something that I had knowledge of or had stopped to consider.  

I think that my own knee-jerk reaction to Tylenol stems from seeing young people OD on it and them not understanding that the move they'd made for attention had, in many cases, now severely altered the course of their life / time.  It can have such an ugly end for something that can be found so readily in most homes.  

Again, thanks for taking the time to help me to broaden the scope of my understanding,
Susan  

[murariji]

I suspect the universal laws that govern Tylenol and livers called in sick when it was time to visit you, What with them thar chaps 'n hat and awl.   :)

[HectorSF]

Thank you for your feedback Susan. I know we all have are different experiences in our lives that form our opinions. I just wanted to add my two cents worth from the perspective of someone with cirrhosis (decompensated) caused by HCV.

Take care.
Hectorsf