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FDA: Acetaminophen warning

by Greg Bernhardt
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Greg Bernhardt
#1
Jan15-14, 06:47 PM
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FDA: Acetaminophen doses over 325 mg might lead to liver damage

You're in pain after surgery, and your doctor prescribes you Vicodin, or maybe Percocet. But when you get home, the pain hasn't subsided and you decide to pop some Extra Strength Tylenol.
Unknowingly, you may have just taken more of the drug acetaminophen than is safe.
Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine). These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose.
FDA warns of acetaminophen liver damage FDA: Pain meds may cause liver damage
The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.
I always keep my pain meds to a minimum after my grandfather basically destroyed his stomach after years of taking Ibuprofen. I know many people who pop pain pills like candy. They think "over-the-shelf" means it's completely safe.
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Evo
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Jan15-14, 07:42 PM
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Quote Quote by Greg Bernhardt View Post
FDA: Acetaminophen doses over 325 mg might lead to liver damage



I always keep my pain meds to a minimum after my grandfather basically destroyed his stomach after years of taking Ibuprofen. I know many people who pop pain pills like candy. They think "over-the-shelf" means it's completely safe.
People should know that in the US, acetaminophen is Tylenol. If you drink alcohol, you should not take tylenol.

Funny, today I was at the doctor getting my percocet refilled and he told me that the amount of acetominaphen was halved. I told him I'd rather not have it at all, and rather have percodan, oxycodone with aspirin instead of tylenol. I have some liver damage and they believe it's from all of the tylenol I've had in the past.

The only "over the counter" pain killer I take now is aspirin. Even that can cause problems.
strangerep
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Jan15-14, 08:21 PM
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Quote Quote by Greg Bernhardt View Post
FDA: Acetaminophen doses over 325 mg might lead to liver damage
Whaaaat???

I'd never heard of "Acetaminophen" before I read your post, so I checked on Wikipedia, and found:
Quote Quote by Wiki
Paracetamol INN (/ˌpærəˈsiːtəmɒl/ or /ˌpærəˈsɛtəmɒl/), or acetaminophen USAN Listeni/əˌsiːtəˈmɪnəfɨn/, chemically named N-acetyl-p-aminophenol, is a widely used over-the-counter analgesic (pain reliever) and antipyretic (fever reducer).
So my "trusty" Panadol tablets may have been responsible in part for liver damage?? For decades I've been taking 2x500mg Panadol tablets for severe migraines. Ker-riste!

I always keep my pain meds to a minimum after my grandfather basically destroyed his stomach after years of taking Ibuprofen. I know many people who pop pain pills like candy. They think "over-the-shelf" means it's completely safe.
Ibuprofen and aspirin are anti-inflammatories, iiuc, hence unsafe for anyone with blood issues (they can cause bleeding). They also irritate the stomach lining, and can lead to internal bleeding. (I almost died that way 12 yrs ago.)

Flatland
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Jan17-14, 10:13 PM
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FDA: Acetaminophen warning

So wait, is the damage done immediately or over a period of time? Because I thought it was well known that Tylenol is harmful for your liver.
Evo
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Jan17-14, 10:20 PM
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Quote Quote by Flatland View Post
So wait, is the damage done immediately or over a period of time? Because I thought it was well known that Tylenol is harmful for your liver.
Both depending on the dose. You can commit suicide by taking a tylenol overdose, but it is a horrible, painful, slow death.
Flatland
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Jan17-14, 10:35 PM
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Quote Quote by Evo View Post
Both depending on the dose. You can commit suicide by taking a tylenol overdose, but it is a horrible, painful, slow death.
Well what the OP posted seems kind of ambiguous. It just says that doses over 325mg is harmful. What if I take a single dose of 500mg Extra Strength Tylenol. Will that cause permanent damage? I'm asking this because I've been taking 500mg Tylenol 3x a day for the last few days due to a wisdom tooth extraction.
Evo
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Jan17-14, 10:55 PM
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Quote Quote by Flatland View Post
Well what the OP posted seems kind of ambiguous. It just says that doses over 325mg is harmful. What if I take a single dose of 500mg Extra Strength Tylenol. Will that cause permanent damage? I'm asking this because I've been taking 500mg Tylenol 3x a day for the last few days due to a wisdom tooth extraction.
No, that's ok, but don't drink alcohol with tylenol. I have refused to take tylenol for years just because it doesn't work for me, so not worth the risk to my liver.
Flatland
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Jan17-14, 11:03 PM
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Quote Quote by Evo View Post
No, that's ok, but don't drink alcohol with tylenol. I have refused to take tylenol for years just because it doesn't work for me, so not worth the risk to my liver.
Would you say that Ibuprofen is safer?
Greg Bernhardt
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Jan17-14, 11:06 PM
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Quote Quote by Flatland View Post
Would you say that Ibuprofen is safer?
No, it has just the same risk to the liver
DrDu
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Jan18-14, 02:27 AM
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Quote Quote by Evo View Post
People should know that in the US, acetaminophen is Tylenol.
Acetaminophen is also a term used only in the US. The INN is paracetamol.
paracetamol is notorious for its low therapeutic span and the risk for kidney damage. If it were a newly developped me
medication, it would never get approval by authorities.
strangerep
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Jan18-14, 03:07 AM
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Quote Quote by DrDu View Post
Acetaminophen is also a term used only in the US. The INN is paracetamol.
paracetamol is notorious for its low therapeutic span and the risk for kidney damage. If it were a newly developped medication, it would never get approval by authorities.
So what pain killer is ok for relieving severe migraine??

I suppose I could take a large dose of nembutal -- which would "relieve" the migraines permanently -- but that's a bit extreme.

Or is this one of those "which way do you want to die" questions?
DrDu
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Jan18-14, 10:27 AM
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Quote Quote by strangerep View Post
So what pain killer is ok for relieving severe migraine??
Did you try triptames?
Greg Bernhardt
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Jan18-14, 11:53 AM
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Quote Quote by strangerep View Post
So what pain killer is ok for relieving severe migraine??
The obligatory "ask your doctor" response :)

But... my wife uses Sumatriptan and it's the only thing that helps her.
Monique
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Jan18-14, 03:04 PM
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What? I get over the counter dose of 1000 mg of paracetamol (Acetaminophen). I'm aware of it's liver toxicity but that was when overdosing (which can happen quickly), but not at a single OTC dose? So throw away the 1000 mg pills and get 300 mg ones?
atyy
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Jan18-14, 03:05 PM
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According to http://www.cnn.com/2014/01/15/health...nophen-dosage/

"Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine). These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose."

"The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action."

"The FDA has set the recommended maximum for adults at 4,000 milligrams per day. It's easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg."

So I doubt that the Tylenol safe dose has been changed. What has long been known is that the safety factor for Tylenol is low, compared to other over the counter drugs. Secondly, because acetaminophen may appear in combination in some over the counter drugs, people taking combinations may accidentally overdose because they are not aware that more than one of the drugs contains acetaminophen.

http://www.ncbi.nlm.nih.gov/pubmed/19735211 "The FDA proposed a decrease in the maximum daily dose from 4,000 to 3,250 mg, reducing the maximum individual dose from 1,000 to 650 mg and relegating 500 mg tablets to prescription status. .................... However, the Committees are advisory to the FDA, their recommendations are not binding and it remains to be seen which of the recommendations will be implemented."

http://www.fda.gov/drugs/drugsafety/.../ucm165107.htm

http://www.fda.gov/Drugs/DrugSafety/ucm381644.htm
"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. ......................... A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product."

http://www.fda.gov/ForConsumers/Cons.../ucm336581.htm
"The current maximum recommended adult dose of acetaminophen is 4,000 milligrams per day, To avoid exceeding that dose:
-don't take more than one OTC product containing acetaminophen,
-don't take a prescription and an OTC product containing acetaminophen, and
-don't exceed the recommended dose on any product containing acetaminophen."

Monique
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Jan18-14, 03:46 PM
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Quote Quote by atyy View Post
"The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action."

"The FDA has set the recommended maximum for adults at 4,000 milligrams per day. It's easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg."
Thanks for the additional information, indeed the daily dose appears unchanged. It's a good reminder to be careful with medication and ask a pharmacist whether it can be combined with OTC products.
Evo
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Jan18-14, 05:28 PM
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Quote Quote by Monique View Post
What? I get over the counter dose of 1000 mg of paracetamol (Acetaminophen). I'm aware of it's liver toxicity but that was when overdosing (which can happen quickly), but not at a single OTC dose? So throw away the 1000 mg pills and get 300 mg ones?
A good example is my pain pills, have 650mg each of acetaminophen, I can take two every 6 hours. That's 5,200 mg in 24 hours, then I take a dose of Excedrin PM to help me sleep, the dosage is 2, that's another 1,000mg. Now my acetaminophen daily consumption is 6,200mg. I have a couple of glasses of wine...
strangerep
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Jan18-14, 07:19 PM
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Quote Quote by Greg Bernhardt View Post
The obligatory "ask your doctor" response :)
Well, I've always found that "ask your doctor" gives better results if one has done as much research as reasonably possible beforehand...

But... my wife uses Sumatriptan and it's the only thing that helps her.
Hmm. That's in the triptan family (which I guess is what DrDu also meant). The Triptan Wiki page warns that it should not be used if there is any history of Transient Ischemic Attack, which must be considered if migraines are associated with auras, i.e., Scintillating Scotoma.


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