Can Over-The-Counter Pain Medications Cause Liver Damage?

  • Thread starter Greg Bernhardt
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In summary, the FDA has warned that doses of acetaminophen over 325 mg may lead to liver damage. This is especially concerning for combination drugs that contain acetaminophen, such as oxycodone (Percocet), hydrocodone (Vicodin), and codeine (Tylenol with Codeine). The FDA is urging doctors to stop prescribing these combination drugs with more than 325 mg of acetaminophen per dose, as there is no evidence that taking more than that amount provides significant benefits. It is also important to note that acetaminophen is the active ingredient in Tylenol, and can cause liver damage when taken with alcohol. While single doses of 500
  • #1
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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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  • #2
Greg Bernhardt said:
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.
 
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  • #3
Greg Bernhardt said:
FDA: Acetaminophen doses over 325 mg might lead to liver damage
Whaaaat? :eek:

I'd never heard of "Acetaminophen" before I read your post, so I checked on Wikipedia, and found:
Wiki said:
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.)
 
  • #4
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.
 
  • #5
Flatland said:
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.
 
  • #6
Evo said:
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.
 
  • #7
Flatland said:
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.
 
  • #8
Evo said:
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?
 
  • #9
Flatland said:
Would you say that Ibuprofen is safer?

No, it has just the same risk to the liver
 
  • #10
Evo said:
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.
 
  • #11
DrDu said:
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? :rolleyes:
 
  • #12
strangerep said:
So what pain killer is ok for relieving severe migraine??

Did you try triptames?
 
  • #13
strangerep said:
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.
 
  • #14
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?
 
  • #15
According to http://www.cnn.com/2014/01/15/health/fda-acetaminophen-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/informationbydrugclass/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/ConsumerUpdates/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."

watch?v=gOuSYNuXHRk#t=99[/youtube]
 
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  • #16
atyy said:
"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.
 
  • #17
Monique said:
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...
 
  • #18
Greg Bernhardt said:
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... :biggrin:

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.
 
  • #19
Greg Bernhardt said:
No, it has just the same risk to the liver

I thought ibuprofen had a lower risk to the liver, but a higher risk to the stomach...

(Not that that's a whole lot better, but still...)
 
  • #20
atyy said:
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."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/ConsumerUpdates/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."

A good post.I think it should be stressed that a lot more acetaminophen is taken by patients unknowingly to them, as a part of combination with other drugs which is why FDA is issuing a warning. This increases the likelihood of daily dosage exceeding > 4 grams per day,since acetaminophen is available as OTC drug .
 
  • #21
strangerep said:
Well, I've always found that "ask your doctor" gives better results if one has done as much research as reasonably possible beforehand... :biggrin:

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.

I think that the scintillating scotomas associated with a classical migraine are not a sign of an ischemic attack. However, scintillating scotoma may also appear in combinations with ischemic attacks. So your doctor should make a correct differential diagnosis.
 
  • #22
My experience with maintenance medicine.

Allow me to share with you all here my own experience with maintenance medicine.

For 3.5 years I was taking faithfully Amlodipine (Norvasc) 5 mgs a day; some weeks ago I noticed swelling in my feet and lower legs, in particular the left foot and lower leg.

My doctor prescribed Amlodipine because being a senior citizen my blood pressure is 'normally' higher than when I was not yet a senior citizen, this medicine is supposed to bring down my blood pressure to a more acceptable 130/80 plus or minus; it worked.

The idea is that with bringing down my 'normally' higher blood pressure I would live longer than otherwise.

Back to my swelling feet and lower legs.

So, I went to see my doctor -- but I did my research about side effects of Amlodipine, one of which quite notorious is pedal edema; he told me: yes, my pedal edema could be the side effect of Amlodipine, what with taking it faithfully for 3.5 years.

I had already stopped taking Amlodipine the day before I went to see my doctor, on my own discretion.

My doctor said to: yes: discontinue with Amlodipine, and he prescribed in its place Irbesartan at 150 mgs per day, telling me that within one week's time the edema should start receding.

But it is now more than two weeks and the edema is not showing any sign of receding, apparently it has gotten more volume.

I did a lot of reading in the net on pedal edema from ingestion of Amlodipine.

The way I see it, the influence of Amlodipine is not going to leave my body in a week's time; in my case it seems to be taking more days than just one week's time.

My doctor prescribed so far four tests which I dutifully undertook, like blood and urine tests, and also venous scans and the socalled 2 d echo with doppler.

But he did not prescribe any new medicines aside from Irbesartan, so I am now since I stopped with Amlodipine, just taking one medicine namely to keep my blood pressure within lower limits, Irbesartan; this medicine is not a cause by side effect of any pedal edema.

This morning after more than two weeks from my first visit to my doctor, I noticed that there is apparently some recession of my pedal edema; it is today in my place Wednesday, Jan. 22, 2014, time is 0453 hours, eight hours in advance of Greenwich.

Come Friday I will see my doctor again, with all the test results, in particular the latest ones on blood with protein, albumin, etc., and most important findings of the venous scans and the 2 d echo with doppler.

I don't know where my doctor got his information that pedal edema from Amlodipine recedes in a week's time, most probably from his experience with his other patients; but in my case I am inclined to think that it is taking more than one week's time.

If my pedal edema is finally into the downward trend, then that is due to -- in my own thinking: the elimination finally of all influence of the 3.5 years of Amlodipine ingestion in my body; now to be optimistic I will just witness how my feet and legs are going to return to normal condition in perhaps some two or more weeks' time.

I hope this information is useful to folks who are into Amlodipine for the control of their blood pressure.

By the way, the Irbesartan is doing all right, that is the only medicine I am taking everyday; and I don't take medicines at all as a routine policy unless it is really needed, like for loose bowel movement which happens even to the most cautious health enthusiasts.

I am a senior citizen but healthy and active.

My doctor also prescribed a treadmill stress test, but when I see him come Friday I will tell him that I will take that test much later, when my edematous feet and lower legs have finally returned to their normal condition.




Yrreg
 
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Related to Can Over-The-Counter Pain Medications Cause Liver Damage?

What is the FDA warning about acetaminophen?

The FDA has issued a warning about the potential risk of liver damage from taking too much acetaminophen, which is the active ingredient in many over-the-counter and prescription pain relievers.

How much acetaminophen is considered safe to take?

The FDA recommends that adults should not take more than 4,000 milligrams of acetaminophen in a 24-hour period. Taking more than this amount can increase the risk of liver damage.

What are the symptoms of acetaminophen overdose?

Symptoms of an acetaminophen overdose may include nausea, vomiting, loss of appetite, stomach pain, and yellowing of the skin or eyes. In severe cases, liver failure and even death can occur.

How can I reduce the risk of acetaminophen overdose?

To reduce the risk of acetaminophen overdose, it is important to carefully read and follow the dosing instructions on the label. Do not take more than the recommended dose and avoid taking multiple medications that contain acetaminophen at the same time.

Are there any alternative pain relievers to acetaminophen?

There are several alternative pain relievers to acetaminophen, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. However, it is important to consult with a healthcare professional before taking any medication to determine the best option for you.

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