Tylenol May Cause Serious Liver Damage
Featured ArticleMain Category: Pain / Anesthetics
Also Included In: Arthritis / Rheumatology; Liver Disease / Hepatitis; Clinical Trials / Drug Trials
Article Date: 05 Jul 2006 - 15:00 PDT
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If you take Tylenol for four days as directed you may be at risk of liver damage, says a new study. Tylenol has been on the market for decades. Previous studies had shown that Tylenol in combination with hydrocodone caused liver damage - experts had thought the liver toxicity was associated with hydrocodone. This new study clearly shows that the Tylenol poses the risk, rather than the hydrocodone.
Researchers from the University of North Carolina, Chapel Hill, USA, were surprised when they found out that the liver damage had nothing to do with the opiate (hydrocodone). They found a previously unrecognized but pretty remarkable effect of acetaminophen (Tylenol) alone when taken as directed for four days.
The scientists said that patients who really need Tylenol should not stop taking it. If they are concerned they should discuss their medication with their doctor before considering switching.
Tylenol is a popular painkiller taken by millions of people all over the world. It is an alternative to aspirin for people who are concerned about its gastrointestinal side-effects.
The researchers found out about Tylenol's effect on liver enzyme levels while they were carrying out a trial on a therapy which included a narcotic drug, hydrocodone, in combination with acetaminophen. The focus was on the liver toxicity effect of the narcotic drug. However, Purdue Pharma, which funded the trial, found that several healthy subjects had high levels of specific liver enzymes - usually an indicator of a health risk for the liver.
The trial was stopped and another team was called in to carry out a new trial which found that Tylenol was the cause of the liver problems. You can read about the current trial in the Journal of the American Medical Association, 5 July issue.
The new trial involved 145 healthy volunteers. They were divided into three groups. The first group received a acetaminophen/opioid combination, the second acetaminophen alone, and the third group received a placebo. They were on their medication(s) or placebo for 14 days. The acetaminophen only group received the maximum recommended daily dosage.
The maximum ALT measurements for each group were as follows:
How many had a maximum ALT measurement 3 times higher than the upper limit of normal:
-- Placebo group - 0%
-- Combination acetaminophen/opioid group - 31% to 44%
-- Acetaminophen only group - 31% to 44%
These results indicate that it was the Acetaminophen, rather than the opioid, that was having the effect.
Dr. Paul Watkins, lead author, said "It was so unbelievable that I am conducting an ongoing study with 50 people. That's not in the JAMA paper, but we're finding that it verifies the findings. I'm quite convinced that if we continue to treat people, they would come back to normal, so that about after a month, I believe liver chemistries would be normal, even continuing." In other words, Watkins believes readings settle down after longer term usage of Acetaminophen.
It is possible that elevated readings of a liver enzyme may not be accurate indicators of risk. Watkins added "In the past, when we've seen liver enzyme abnormalities to this extent, it has indicated to us physicians that there is significant liver injury or damage occurring. Since we have decades of experience and know the safety of acetaminophen, are the tests as good as we thought they were? Maybe they're not good predictors as to which drugs are going to have liver problems."
How many doctors have stopped other medications which were given in combination with acetaminophen? As recommended doses of acetaminophen have not been previously recognized to cause liver enzyme elevations, doctors may have carried out costly liver evaluations unnecessarily. Watkins wondered how many other drugs, such as statins, may have been stopped because doctors suspected they were causing liver problems, when in fact, it was the acetaminophen.
"Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily"
A Randomized Controlled Trial
Paul B. Watkins, MD; Neil Kaplowitz, MD; John T. Slattery, PhD; Connie R. Colonese, MS; Salvatore V. Colucci, MS; Paul W. Stewart, PhD; Stephen C. Harris, MD
JAMA. 2006;296:87-93.
Link to Abstract.
Written by: Christian Nordqvist
Editor: Medical News Today.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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8 Feb. 2012. <http://www.medicalnewstoday.com/articles/46607.php>
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Visitor Opinions In Chronological Order (3)
Liver Toxicity At Normal Doses Of Acetaminophen
posted by Donald H. Marks MD PhD on 7 Jan 2007 at 5:59 pmAcetaminophen is an analgesic (pain reliever) and anti-pyretic (controls fever) medication which is sold without prescription in over 200 types of pain relievers and cold remedies under many trade names, including Tylenol. NSAID (such as ibuprofen and naproxen) and COX-2 inhibitors (Vioxx, Celebrex, Bextra) are also analgesic and anti-pyretic, and in addition are anti-inflammatory.
Acetaminophen differs from NSAID and COX-2 inhibitors in that it is not anti-inflammatory. Although thought of as relatively non-toxic, and taken by 100 million or more Americans each year, there are a number of acetaminophen-related liver injuries and deaths reported every year to poison control centers, including those from accidental overdose. The initial symptoms from ingesting a toxic dose can be falsely disalarming, but after several days can progress to irrevocable liver failure and death. Early therapeutic intervention for acetaminophen toxicity is crucial, but because the symptoms and liver damage lag from the ingestion time, a number of unfortunate persons do not have their symptoms immediately recognized, and do not receive appropriate therapy for a number of days.
Although the currently recommended maximal therapeutic dose for acetaminophen is 4 grams per day, instructions for use are often confusing, and can allow 5-7 grams/day. This by itself would not necessarily become a clinical problem if toxicity would really start at 7.5 – 10grams/day, however, there have been several reports where doses between 4 – 7.5grams/day have been associated with liver injury and failure. For a drug with a narrow dosing margin of safety, an overdose could be little more than the recommended dose.
A recent study showed that 41 of 106 patients taking acetaminophen alone or in combination with another drug saw their liver enzymes increase to more than three times the upper limit of normal – a marker of liver inflammation. Twenty-seven patients had enzyme levels exceeding five times normal, and eight patients had eight times the normal level of liver enzymes. Of the 39 patients on a placebo, only one had enzymes that exceeded twice the normal level.
One of the patient variables that influences the toxicity of acetaminophen is fasting, and there have been several reports implicating fasting as a factor in liver toxicity seen with normal doses of acetaminophen. An individual who takes acetaminophen for symptoms of a cold, for example, may not be hungry, and have a decreased food and fluid intake, which potentially could exacerbate acetaminophen toxicity. Nausea is another of the early symptoms of acetaminophen-induced toxicity. Patients who feel nauseated will stop eating and drinking, therefore further enhancing the toxic effect of acetaminophen.
Although commonly used and thought of as relatively harmless, it is becoming clear that acetaminophen can be quite toxic, even at recommended doses. Providers need to communicate these facts to their patients and caregivers who may be using acetaminophen. http://ahe6.tripod.com/extantmedical/id25.html
Acetaminophen Is Underrated As A Toxic Product
posted by Dr. Jacob R. Raitt on 26 Mar 2008 at 10:24 amAs early as the 1970's, acetaminophen hepatic toxicity was noted. The FDA, in 1977 stated that this medication should not be administered in excess of the recommended dosage, and added that it should not be taken for longer than 10 days. In 2006, the American Liver Foundation stated that acetaminophen should not be taken for more than 3 consecutive days, and then only sporadically. However, in this country, the sale of acetaminophen is unlimited, and is included in a plethora of products where its individuality disappears. The sale of acetaminophen must be placed under some type of sale control, to protect the residents of this nation, as well as those professionals who recommend its use.
Taking Percocet 10/325 for over a year
posted by Robert on 2 Feb 2012 at 10:23 amI have been taking 5 of these a day as prescribed by my pain managment doctor. So that's 1625mg of Tylenol a day! What should I say to my doctor to get my off of this dangerous drug. I have ruptured disks in my back so there's no way I can live with out pain meds.
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