Acetaminophen is a common over the counter pain medicine.
Acetaminophen (in painkillers such as Tylenol) is present in hundreds of products and
may sometimes be unsafe even when used at the maximum daily
doses recommended on package labeling. Acetaminophen (APAP) is the most common
drug overdose in pregnancy. Acetaminophen
(Tylenol, others) isn't a NSAID, but it sometimes does reduce pain and fever.
Unlike NSAIDs, however,
this medication does not reduce inflammation.
The words acetaminophen and paracetamol both come from
the chemical names for the compound: N-acetyl-para-aminophenol and para-acetyl-amino-phenol.
In some contexts, it is shortened to apap, for N-acetyl-para-amino-phenol.
Despite years of educational campaigns and other federal actions,
acetaminophen is the leading cause of liver failure in the U.S., sending 56,000
people to the emergency room annually. One wonders why it is still available
without a prescription whereas some natural herbs and supplements, that have a
significantly better safety profile, have been removed from the market.
Acetaminophen safety, risks,
liver harm - Acetaminophen side effects, toxicity
Acetaminophen is one of the most common agents deliberately
ingested in self-poisoning episodes and a leading cause of acute liver failure
in the western world.
Acetyl-L-Cysteine is widely acknowledged as the
antidote of choice for this poisoning.
Taken occasionally and in dosages less than 500 mg, acetaminophen
has few side effects and is generally safe. However, if you frequently take more acetaminophen than is
recommended side effects can occur. Taking a large dose of acetaminophen
with alcohol increases the side effect risk and can lead to sudden and severe
problems, such as liver failure. Acetaminophen is included in many
different medications for pain, headaches, colds and sleep aids. Be sure
to read the ingredients listed for all your medications to make sure you
are not consuming more acetaminophen than you realize.
Additional acetaminophen side effects include diarrhea; increased
sweating; loss of appetite; nausea or vomiting ; stomach cramps or pain;
swelling, pain, or tenderness in the upper abdomen or stomach area.
April 2009 - FDA announced that over-the-counter pain relievers such as Tylenol and Advil will carry new, bolder warnings about the risk of liver damage or stomach bleeding. Products containing acetaminophen, such as Johnson & Johnson's Tylenol, will carry a prominent package warning about the risk of severe liver damage if consumers take too much of the drug or take it with too much alcohol.
Acetaminophen and liver toxicity
More than a third of healthy adults starting
acetaminophen / paracetamol at the maximum recommended daily dosage of 4 grams
will exhibit ALT liver enzyme elevations. The lead researcher is Dr. Paul B. Watkins, from
the University of North Carolina in Chapel Hill. Dr. Watkins's study involved
145 healthy adults who were randomized to receive acetaminophen alone,
acetaminophen plus opioid in one of three combinations, or placebo for 14 days.
In all of the acetaminophen groups, the acetaminophen dosage was 4 g/day. No ALT
elevations greater than three times the upper limit of normal were seen in the
placebo group. By contrast, the incidence of such elevations ranged from 31% to
44% in the four groups receiving acetaminophen. As noted, treatment with opioids
did not further increase the ALT elevation seen with acetaminophen. Serum
acetaminophen levels were usually not measurable at the time of the elevation.
JAMA 2006;296:87-93.
Liver Failure acetaminophen side effect
In patients with acute liver failure, a test
can determine whether acetaminophen toxicity is involved. More than 56,000 emergency room visits and nearly 500 deaths in the US
each year are attributed to acetaminophen toxicity, owing to either intentional
or unintentional overdoses. Acetaminophen toxicity is currently the most common
cause of acute liver failure in the US and Europe.
Although intentional acetaminophen overdose is fairly easy to diagnose, in
unintentional overdoses, the diagnosis can be elusive, leading to a delay in the
administration of potentially life-saving treatment.
In animal and human studies, "serum acetaminophen-protein adducts" or mutations,
are specific biomarkers for drug-related toxicity. Gastroenterology March 2006.
Acetaminophen and Osteoarthritis
The evidence to date suggests that NSAIDs are superior to acetaminophen
for improving knee and hip pain in people with osteoarthritis. In fact, it is
possible that chronic use of acetaminophen could harm or cause damage to
articular tissue, or, at the least, harm liver tissue. For osteoarthritis pain
and joint health, glucosamine and chondroitin are preferred.
Acetaminophen and tooth
extraction
Paracetamol (Panadol) , the pain killer known as acetaminophen in the
U.S. and sold under the trade names Tylenol in the US and Panadol in the UK, is
an effective treatment for the pain following wisdom tooth extraction.
Acetaminophen Drug Recall
November 2006 - Perrigo Co.. a major manufacturer of store-brand acetaminophen,
recalled 11 million bottles of the pain-relieving acetaminphen pills after
discovering some acetaminophen pill were contaminated with metal fragments.
There were no immediate reports of injuries or illness. Perrigo Co. said it
discovered the metal bits during quality-control checks. The
drug company passed 70
million acetaminophen pills through a metal detector and discovered the metal in
about 200 caplets. The fragments ranged in size from “microdots” to portions of
wire one-third of an inch long.
Perrigo company did not disclose the chains for which it manufactures the
store-brand acetaminophen.
Acetaminophen medication questions
Q. I would like to use
acetylcysteine to protect my liver from the amount
of acetamenophin I am required to take on a daily basis due to my injuries. How
much would I need to take of acetylcysteine?
A. We have not seen any studies regarding the long term
use of acetaminophen and acetylcysteine, however a dose of 100 mg a day would
seem reasonable.
Q. People who are addicted to pain medications, such as
hydrocodone, often take way too much APAP (acetaminophen) in the process. For
over a year, I was one of them. I averaged over 30 10/325 tablets a day, often
taking much more (several times 80 or more). Knowing what I was doing to my
liver, I researched the procedure used in the ER for acetaminophen overdose and
proceeded to treat myself accordingly, using OTC NAC (n-acetylcysteine). I am
thankfully free of this addiction now (over 9 months), but still communicate
with others in the throws of it. I have suggested to them that they should stock
up on N-acetyl Cysteine and use it if necessary (obviously the right solution is
to go straight to the ER if you've taken over 10g of acetaminophen, but we both
know that may not happen with these folks). When I pointed this out, I was
overwhelmingly ridiculed and dismissed by those who said the NAC available over
the counter is nothing like that used in the ER. I know there is probably a
difference, but given that one is not going to seek proper medical treatment,
isn't the NAC we have access to a great alternative? What exactly is the
difference between the two formulations?
A. Based on my limited knowledge, since I have not seen
head to head research comparisons, I tend to think that the benefits of oral and
intravenous NAC would not be too different, but I have no proof of this.
Q. I recently read that taking echinacea with
acetaminophen "can severely damage your liver" and that taking kava kava or echinacea while on a
statin med for cholesterol "can trigger potentially fatal
liver damage". (These statements were attributed to a book by George Grossberg,
M.D.) Are these statements supported by the available evidence? I am on a statin
and sometimes take acetaminophen for arthritis pain.
A. We have not heard of
Echinacea causing serious liver harm,
perhaps in rare cases. Acetaminophen can certainly harm the liver, statins
could, and
Kava may in rare cases. The combinations would not be a good idea.
Q. I recently started taking
hoodia supplements for
weight loss and was wondering if there was any information regarding the use of
this herbal extract along with acetaminophen.
A. We are not aware of any such studies or interactions.