Showing posts with label Acetaminophen Safety. Show all posts
Showing posts with label Acetaminophen Safety. Show all posts

Tuesday, March 13, 2018

New Study: Acetaminophen Safety During Flu Season

New Study: Acetaminophen Safety During Flu Season

During the flu season we all reach for medications to help alleviate our symptoms, with so many over the counter choices containing the active ingredient acetaminophen, its no wonder we might be taking more than the recommended daily dose.

This is especially dangerous for people who go undiagnosed with liver disease. In the US nonalcoholic fatty liver disease (NAFLD) is projected to surpass viral hepatitis as the leading cause of liver transplantation, but most people don't even know they have it. Sound familiar? The same can be said for nearly half the people with hepatitis C, because new infections go undiagnosed as well.

In a new study headed up by Saul Shiffman, Ph.D, published in the March issue of British Journal of Clinical Pharmacology, the good doctor found during flu season acetaminophen overdosing increases; over-dose occurred more often in cold-flu season (6.5%) than in off-season (5.3%), due to increased use of OTC combinations treating upper-respiratory cold/flu symptoms.
Confirming; a need for consumer education about the proper use of acetaminophen medications.

A link to the research article is provided below, however, I highly suggest you read the following patient-friendly overview, written by Dennis Thompson; Fighting a Cold or Flu? Beware of Overdosing on Tylenol. Thompson breaks down the study, along with interviewing experts on the importance of using acetaminophen; in both healthy people, and those with liver disease, cirrhosis, or on a transplant list.

Reuters Health
Acetaminophen overuse spikes during cold and flu season
Last Updated: 2018-03-29
By Lisa Rapaport
(Reuters Health) - A growing number of people are taking high doses of acetaminophen, and many take so much during cold and flu season that they run the risk of liver and kidney damage, two studies suggest.

What is known about this subject
• Acetaminophen is an active ingredient in many prescription and over-the-counter (OTC) medications.
• When taken in high doses, acetaminophen can cause liver injury.
• Users sometimes exceed the maximum recommended dose of 4 grams per day.

What this study adds
• Over the course of 7 days, 6.3% of acetaminophen users exceed 4 grams on at least one day.
• Such over-dose occurred more often in cold-flu season (6.5%) than in off-season (5.3%), due to increased use of OTC combinations treating upper-respiratory cold/flu symptoms.

We found that 6.3% of acetaminophen users exceeded the maximum recommended daily dose of acetaminophen at least once during a week in which they used acetaminophen, and1.4% exceeded this limit on the majority of days; the limit was exceeded on 3.7% of acetaminophen usage days. This was somewhat more frequent during cold/flu season. The seasonal increase was mainly attributable to increases in the use of OTC acetaminophen medications containing a combination of ingredients designed to treat upper respiratory symptoms, in addition to treating pain and fever. These findings suggest the need for consumer education about the proper use of acetaminophen medications, including limiting the dose to that specified in the medication directions, with some special emphasis during cold/flu season on limiting intake of medications treating upper-respiratory symptoms.
Complete Research Article -

Tylenol & Viral Hepatitis
As for people with HCV, the following document defines acetaminophen use for people; with or without cirrhosis.

The maximum dose of acetaminophen that adults can safely take over a 24-hour period is four grams, which equals eight extra-strength pills or about 12 regular-strength pills. (An extra-strength pill contains 500 mg and a regular strength pill contains 325 mg).

Experts suggest, even for healthy people - a safe practice is to take only what you need - and to not exceed 3,000 mg a day if at all possible.

Stay healthy

Monday, September 4, 2017

Baby Boomers - What About HCV, Vaccinations, Liver Health & All That Jazz 

Baby Boomers - What About HCV, Vaccinations, Liver Health & All That Jazz
Whether you're a baby boomer, new to hepatitis C, thinking about getting tested or just looking to close a few knowledge gaps, thanks for stopping by.

With the flu season on its way, the focus today is on vaccinations for adults with HCV, risk associated with the use of acetaminophen, aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). Also a look at risky drinking and drug misuse among baby boomers in the UK and Australia. As for exercise, NPR talks about the dangers of prolonged sitting and risk of a host of diseases, yep, among baby boomers. Last but not least, getting tested for the hepatitis C virus.

Immunization Action Coalition
Vaccinations for adults with hepatitis C infection
One-page sheet describes vaccinations that HCV-positive adults need

Click On Image To Enlarge

Source Link -

Get Your Flu Shot
People 65 years and older, living with chronic liver disease, cirrhosis and liver transplant recipients are particularly at risk from the flu and are more susceptible to flu-related complications.

Recommended Reading
Read all past and current Seasonal Flu Vaccine articles posted on this blog.

More information is available on the CDC website: Frequently Asked Flu Questions 2017-2018 Influenza Season

During The Flu Season Protect Your Liver
When the flu season hits home the first thing we do is run out to purchase an over-the-counter medication to help relieve cold and flu symptoms. According to the FDA, more than 600 medications used to help relieve pain and reduce fever, including prescription and over-the-counter (OTC) medications contain the active ingredient acetaminophen. When checking the label for "acetaminophen" it may not be spelled out in full on the container's prescription label. Abbreviations such as APAP, Acetaminoph, Acetaminop, Acetamin, or Acetam may be used instead.

To lower your risk of liver damage, the FDA suggests the following:
  • Follow dosing directions and never take more than directed; even a small increase in the recommended dose can cause liver damage.
  • Don't take acetaminophen for more days than directed.
  • Don't take more than one medicine that contains acetaminophen at a time. To determine if a medicine contains acetaminophen, read the "Drug Facts" label under "Active Ingredients". It will either say "acetaminophen" or "APAP." (APAP is an acronym for the chemical name, N-acetyl-paraaminophenol.)
  • Talk to your doctor before you take acetaminophen if you drink three or more alcoholic beverages every day, have liver disease, or take warfarin, a blood thinner. Together warfarin and acetaminophen may raise your risk of bleeding.
For a complete list of drug brand names containing acetaminophen, click here.

Tylenol & Viral Hepatitis
Hepatitis C Online is a great site with educational tools to learn more about diagnosis, treatment and HCV management. The following document addresses acetaminophen, aspirin and non-steroidal antiinflammatory drugs (NSAIDs) for people with or without cirrhosis.

Acetaminophen (Tylenol) is a known hepatotoxin that can cause clinically important hepatotoxicity, either through an acute overdose or when taken on a regular basis (even at lower doses): in one large study that examined causes of acute liver failure, patients taking a dose less than 4 grams per day accounted for 7% of the total cases and in some were taking doses as low as 1 gram per day. Among healthy volunteers taking 4 grams per day for 14 days, more than 30% developed alanine aminotransferase (ALT) values in excess of 3 times the upper limit of normal. Concurrent alcohol use greatly increases the chance of acute or chronic acetaminophen-induced hepatotoxicity. Studies have also shown an increased risk of acute liver injury in patients with chronic hepatitis C following acetaminophen overdose, but none have examined the safety of long term, low dosages of acetaminophen in patients with chronic hepatitis C. Guidelines for the safe use of acetaminophen in HCV-infected persons do not exist. Considering many patients with chronic hepatitis C have limited pain treatment options, most experts believe low dosages of acetaminophen (up to two grams per day) can safely be used in most patients with chronic hepatitis C infection without cirrhosis; those with cirrhosis should limit their intake of acetaminophen to one gram per day. Patients drinking excess alcohol should avoid taking acetaminophen altogether. Clinicians should remind patients that many narcotic combination pills and over-the-counter cold and flu medications may contain acetaminophen. Patients taking acetaminophen should have laboratory monitoring for hepatotoxicity every 3 to 6 months.

Aspirin and Nonsteroidal Anti-inflammatory Medications:
A few different types of NSAIDs are available over the counter:
- Aspirin (Bayer, Bufferin, Excedrin) Each caplet of Excedrin Extra Strength Pain Reliever contains 250 milligrams (mg) of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine
- Ibuprofen (Advil, Motrin IB)
- Naproxen (Aleve)

Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) are generally safe for patients with hepatitis C when taken at standard doses.  The one exception is in patients who have cirrhosis: NSAIDS and aspirin are best avoided in patients with cirrhosis, especially those with decompensated cirrhosis. In patients with decompensated cirrhosis, the use of NSAIDS and aspirin may further increase the inherent risk these patients have for developing nephrotoxicity and gastrointestinal bleeding. Patients with chronic hepatitis C who do not have cirrhosis may take aspirin or NSAIDs at low or standard recommended dosages, with food and water.  Those with cirrhosis who have short-term, minor pain should, in general, avoid taking aspirin or NSAIDs, but can take acetaminophen in this setting as long as the dose does not exceed one gram per day.  In the unfortunate situation involving a patient with cirrhosis who has joint or musculoskeletal pain unresponsive to acetaminophen, NSAIDs can be used for a very brief period of time if given at the lowest daily dose possible.
Download PDF, here.

Of Interest

Harvard Heart Letter
Daily aspirin users 75 or older: Consider taking a stomach-protecting drug
Research we're watching

Roughly half of Americans ages 75 or older take a daily, low-dose aspirin to prevent a heart attack or stroke. New research suggests these people might benefit from taking a stomach-protecting drug to prevent a higher-than-expected risk of gastro-intestinal (GI) bleeding.

The study, published online June 13, 2017, by The Lancet, involved nearly 3,200 people who were prescribed aspirin because of a previous heart attack or stroke. Researchers followed them for up to 10 years to see how many were hospitalized for bleeding — a well-known side effect of aspirin use. Upper GI bleeding usually results from a stomach ulcer, which can cause anemia, heartburn, and abdominal pain.

The risk of serious GI bleeding was much higher among people ages 75 or older compared with people ages 65 or younger. But bleeding events were much less common in people taking prescription heartburn drugs called proton-pump inhibitors, such as omeprazole (Prilosec) and esomeprazole (Nexium). These drugs can reduce GI bleeding by as much as 90%, according to the study authors.

Recommended Reading
HCV Advocate's fact sheet contains information about acetaminophen for people with chronic hepatitis B or C. In this article; It’s Flu Season: When You Have Hepatitis B, Too Much Tylenol Can Damage Your Liver, Christine Kukka explains the dangers of Tylenol for people living with hepatitis B. Or check out this article from Pharmacy Times about general risks associated with over-the-counter pain medications.

Baby Boomers Alcohol & Drug Misuse
A rise in alcohol and drug misuse among the over 50s (commonly known as “baby boomers”) is causing concern, warn experts.
Researchers at South London and Maudsley NHS Foundation Trust and Flinders University in Australia, say the number of people aged over 50 experiencing problems from substance misuse is growing rapidly, with the numbers receiving treatment expected to treble in the United States and double in Europe by 2020.

Commenting on the research, which appeared in the British Medical Journal (BMJ), Vanessa Hebditch, the British Liver Trust Director of Communications and Policy said,

“Urgent action is needed to tackle drink and drug misuse among baby boomers – this research adds to the growing body of data in the UK suggesting that alcohol and other substance misuse is increasing among those in their mid-50s and older.

The over 50s have seen a time when filling up your supermarket trolley with wine and drinking at home has become normalised so that is part of our culture and this all too easily becomes habit forming. Alcohol has become increasingly acceptable and affordable.

The British Liver Trust advises that one easy step that people can take is to make sure that they have two –three consecutive days off every week from drinking – this not only reduces overall units but stops dependency.

However, if we are to turn around the massive increases in liver disease that we are seeing as a result of drinking too much we also need Government measures which tackle the affordability, availability and promotion of alcohol.”

The research found that in both the UK and Australia, risky drinking is declining, except among people aged 50 years and older, they explain. There is also a strong upward trend for episodic heavy drinking in this age group.

With alcohol being the most common substance of misuse among older people, under-detection of alcohol problems is of immediate concern – and may increase further as baby boomers get older because of their more liberal views towards, and higher use of, alcohol, they write.

A lack of sound alcohol screening to detect risky drinking may result in a greater need for treatment, longer duration of treatment, heavier use of ambulance services, and higher rates of hospital admission.

Research suggests that treatment programmes adapted for older people with substance misuse were associated with better outcomes than those aimed at all age groups.

However, the authors point out that clinicians will need improved knowledge and skills in assessing and treating older people at risk of substance misuse.

“There remains an urgent need for better drug treatments for older people with substance misuse, more widespread training, and above all a stronger evidence base for both prevention and treatment,” they write.

“The clinical complexity of older adults with substance misuse demands new solutions to a rapidly growing problem. So far, there has been little sign of a coordinated international approach to integrated care,” they conclude.

Read the full article here

Baby Boomers - Walk A Little Each Day
Get Off The Couch Baby Boomers, Or You May Not Be Able To Later
In a study of sitting and walking ability that surveyed people ages 50 to 71 across 8 to 10 years, those who tended to sit the most and move the least had more than three times the risk of difficulty walking by the end of the study, when compared to their more active counterparts.

Some ended up unable to walk at all. The study appears in the current issue of The Journals of Gerontology: Medical Sciences
Continue reading the article, or listen to the audio posted today over at NPR....

HCV & Baby Boomers
USA Today
Most boomers infected with liver-damaging hepatitis C virus do not know it
Boomers grew up and became young adults before the virus was identified in 1989. So it is likely many were infected through medical procedures and transfusions before improved infection control techniques and blood screening nearly eliminated those risks, CDC says. 
Continue reading...

Most of the 3.5 million Americans living with hepatitis C are baby boomers born from 1945 to 1965. Baby boomers are five times more likely to be infected with hepatitis C than other age groups. 
CDC officials recommend Hepatitis C testing for the following groups of people:

1- People born from 1945 through 1965. 
2- Current or former injection drug users, including those who injected only once many years ago.
3- Recipients of clotting factor concentrates made before 1987, when more advanced methods for manufacturing those products were developed.
4- Recipients of blood transfusions or solid organ transplants before July 1992, when better testing of blood donors became available.
5- Chronic hemodialysis patients.
6- Persons with known exposures to HCV, such as
health care workers after needlesticks involving HCV-positive blood
recipients of blood or organs from a donor who tested HCV-positive

7- Persons with HIV infection.
8- Children born to HCV-positive mothers.
Learn More Here.....

New Hepatitis C Infections Nearly Tripled over Five Years
The rising number of hepatitis C infections are primarily a result of increasing injection drug use associated with America’s growing opioid epidemic, according to the federal Centers for Disease Control and Prevention. Over five years, the number of new infections has nearly tripled, reaching a 15-year high. The highest number of new infections are among 20- to 29-year-olds.

Until next time.

Wednesday, June 28, 2017

Patient Friendly Video On Managing Medications With Liver Disease & Cirrhosis

Cirrhosis - Managing Medications with Liver Disease

Published on Jun 27, 2017
Source - American Liver Foundation Great Lakes Division

A quick overview on the safety and use of medications commonly used to treat various complications of cirrhosis.

Topic Highlights
Water Pills - Diuretics
Over The Counter Drugs (OTC) - Drugs with hidden acetaminophen (Tylenol)
Herbal Products
Prescription drugs that can cause confusion
Hepatitis C Medications
Transplant Medications

Monday, January 30, 2017

Scientists have shed new light on how the common painkiller paracetamol causes liver damage

Paracetamol study could open door for way to treat liver damage
Scientists have shed new light on how the common painkiller paracetamol causes liver damage.

Their findings may offer valuable insights into poisoning caused by an excess dose, which can be difficult to treat and may prove fatal.

The discovery could inform research into therapies to counteract harm caused by the drug, which is the leading cause of acute liver failure in the Western world.

Scientists at The University of Edinburgh studied the impact of paracetamol on liver cells in human and mouse tissue.

Tests showed that even relatively low doses of paracetamol can damage the liver by harming vital structural connections between adjacent cells in the organ.

When these cell wall connections – known as tight junctions – are disrupted, the liver tissue structure is damaged, cells are unable to function properly and they may die.

This type of cell damage is known to occur in liver conditions including hepatitis, cirrhosis, and cancer, but until now it was not linked to paracetamol toxicity.

Researchers aim now to develop a reliable method of using human liver cells as an alternative to animal testing. They then will seek to examine how varying paracetamol doses and timescales affect toxicity in the liver, and identify potential targets for new drugs.

The study, involving researchers from the universities of Edinburgh and Oslo, and the Scottish National Blood Transfusion Service, was published in Nature Scientific Reports. It was supported in part by the Biotechnology and Biological Sciences Research Council and the Chief Scientist Office.

Nature Scientific Reports
Low-dose acetaminophen induces early disruption of cell-cell tight junctions in human hepatic cells and mouse liver

Dr Leonard Nelson, of The University of Edinburgh’s Hepatology Laboratory and Institute for Bioengineering, who co-led the study, said: “Paracetamol is the world’s preferred pain remedy – it is cheap, safe and effective. However, drug-induced liver damage remains a significant problem. Our findings reinforce the need for vigilance in paracetamol use, and could help discover how harm caused by its adverse use might be prevented.”

Co-author Pierre Bagnaninchi, of the university’s MRC Centre for Regenerative Medicine, said: “Although liver damage cause by paracetamol toxicity has been the subject of intense study for 40 years, developments in biosensor technology are enabling a fuller picture of the biological mechanisms involved, which is a huge step in helping develop ways to manage the risks of an overdose.”

Source -

BBSRC invests in world-class bioscience research and training on behalf of the UK public. Our aim is to further scientific knowledge, to promote economic growth, wealth and job creation and to improve quality of life in the UK and beyond.

Funded by Government, BBSRC invested £473M in world-class bioscience, people and research infrastructure in 2015-16. We support research and training in universities and strategically funded institutes. BBSRC research and the people we fund are helping society to meet major challenges, including food security, green energy and healthier, longer lives. Our investments underpin important UK economic sectors, such as farming, food, industrial biotechnology and pharmaceuticals.

For more information about BBSRC, our science and our impact see:
For more information about BBSRC strategically funded institutes see:

Wednesday, November 30, 2016

Acetaminophen, supplements and other medications may trigger drug-induced liver injury

Acetaminophen, supplements and other medications may trigger drug-induced liver injury

Figure 1:
Risk factors for development of drug-induced liver injury (DILI).
Original art: graphic art created by Roger Yoder Iconic Images, provided by PresenterMedia.

Download Full Text Article @ AACN Advanced Critical Care

More than 1,000 medications, with acetaminophen being the most common, have been associated with drug-induced liver injury (DILI).

Diagnosis can be challenging due to the multitude of contributing factors, and timely recognition and clinical response may mean the difference between recovery and acute liver failure or even death.

DILI affects an estimated fewer than 10 people in every 10,000 exposed persons. The condition is dose-dependent or an adverse reaction to a medication, dietary supplement or other substance.

An article in the current issue of AACN Advanced Critical Care, "Drug-Induced Liver Injury," discusses the clinical impact of DILI and reviews the medications that most frequently cause it.

The article is co-authored by Leslie Hamilton, PharmD, BCPS, BCCCP, associate professor of clinical pharmacy in the College of Pharmacy at University of Tennessee Health Science Center, Knoxville; Angela Collins-Yoder, RN, PhD, CCNS, ACNS-BC, clinical professor, University of Alabama Capstone College of Nursing, Tuscaloosa, and critical care nurse specialist, Sacred Heart Pensacola Hospital, Pensacola, Florida; and Rachel E. Collins, BA, Auburn University Harrison School of Pharmacy, Auburn, Alabama.

"The liver helps remove toxins, which makes it especially vulnerable to injury from either short-term intake above recommended levels or long-term usage that allows toxins to build up," Collins-Yoder said. "Recognizing the clinical signs and symptoms is crucial to prompt treatment and effective patient care." Depending on the contributing factors and the level of damage to the liver, patients with mild and moderate signs and symptoms may recover normal liver function after the triggering substance is identified and use is discontinued. Other patients may experience more severe damage, progressing to acute liver failure.

About 46 percent of persons with acute liver failure in the United States have liver damage associated with acetaminophen, making it the most common cause of DILI. Since acetaminophen is often an ingredient in over-the-counter and prescription pain medications, patients may take higher doses than needed.

A more infrequent type of DILI is triggered by an adverse reaction to prescription medications, herbal dietary supplements or other substances, including:

• Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, naproxen and others

• Antibiotics and antiviral agencies, such as amoxicillin-clavulanate, sulfamethoxazole-trimethoprim and nitrofurantoin

• Antileptic agents, such as volproic acid and carbamazepine

• Statins

• Novel anticoagulants

• Proton pump inhibitors

• Methotrexate

• Azathioprine

• Sulfasalazine

• Herbal and dietary supplements

The article follows a presentation by the authors at the National Teaching Institute and Critical Care Exposition, the annual conference of the American Association of Critical-Care Nurses (AACN), which publishes the journal.

Story Source:
Materials provided by American Association of Critical-Care Nurses (AACN). Note: Content may be edited for style and length.

Journal Reference:
L. A. Hamilton, A. Collins-Yoder, R. E. Collins. Drug-Induced Liver Injury. AACN Advanced Critical Care, 2016; 27 (4): 430 DOI: 10.4037/aacnacc2016953

Thursday, May 28, 2015

Variations in paracetamol(acetaminophen)-induced liver failure among European countries

Large but unexplained variations in paracetamol (acetaminophen)-induced liver failure among European countries

Six-times higher risk in Ireland and a 2-fold higher risk in the UK highlighted in study


A fifty-fold between-country difference in rates of paracetamol-induced acute liver failure that leads to liver transplant (ALFT) has been revealed by a study that compared patient data from seven countries at the request of the European Medicines Agency: France, Greece, Ireland, Italy, Netherlands, Portugal and the UK. Researchers discovered that this variation was even more pronounced on a per-capita basis, with a 200-fold difference in ALFT cases. Publishing these findings in the British Journal of Clinical Pharmacology, the authors call for further research to identify the underlying causes.

Paracetamol is used extensively to combat pain, but when taken above the recommended dose it can cause severe liver damage. On occasions the damage is so severe that it leads to complete liver failure and, when this occurs, patients are recommended to have a transplant. A Study of Acute Liver Transplantation (SALT) identified patients with paracetamol-linked liver failure between 2005-2007, and compared the rate of these events per person and also per tonne of paracetamol sold in the country.

Although the average event rate of ALFT in the seven participating European countries over three years was one case per 6 million inhabitants per year, the rate was the highest in Ireland (one case for every 286,000 inhabitants) and the lowest in Italy (one case for every 180 million people in Italy), with a 200-fold difference between these two countries. A similar variation was seen when looking at the frequency of events for each tonne of paracetamol sold: while there was one ALFT event in Ireland for every 20.7 tonnes of paracetamol sold, the value was only one for every 1,074 tonnes sold in Italy.

Furthermore, paracetamol overdose represented 20% of all causes of this type of ALFT across Europe, but rose to 52% in Ireland and 28% in the UK, but dropped to only 1% in Italy. There were no cases at all recorded in Greece. Intriguingly while France had the highest per-person use of paracetamol, it had the third-lowest ALFT rate.

"Overall, we found a six-times higher risk in Ireland and a two-fold higher risk in the UK compared to the average of the countries participating in the study," says lead researcher Sinem Ezgi Gulmez, the associate Professor of Pharmacology at the University of Bordeaux, France.

Gulmez also points out that the highest rates of overdose ALFT per metric ton of paracetamol sold or per inhabitant were found in the two English-speaking countries (Ireland and the UK) in the study: "Since we do not have event rates for overdoses not leading to liver failure, we cannot conclude anything about the rates of non-ALFT overdoses in the different countries, but indicators point to more common use of paracetamol for self-poisoning in these countries".

"The differences in the figures for harm caused by paracetamol within different countries in Europe are not marginal, and suggest that there are some underlying causes. Paracetamol overdose is a serious public health issue and we should start looking into hepatotoxicity associated with paracetamol at normal doses," says Gulmez.

Tuesday, March 25, 2014

Liver Damage From Opioid/Acetaminophen Combination Products

Opioid/Acetaminophen Combination Products
A few days ago CNN reported on the FDA's recommendation that physicians stop prescribing pain medication that contain more than 325mg of acetaminophen.

Acetaminophen is commonly found in over the counter medication, the most popular is Tylenol. Acetaminophen is also combined in many prescription products, usually opioids, for example codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

To reduce the risk of liver damage, in 2011 the FDA asked drug manufacturers to limit the amount of acetaminophen in prescription medication, which were predominantly opioid products; to no more than 325 milligrams(mg) of acetaminophen in each tablet or capsule.  The FDA also required manufacturers to update labels warning consumers of the potential risk for severe liver injury.

Although, over the counter acetaminophen products were not affected by the FDA's action, in the fall of 2011 new dosing instructions for TYLENOL were put in place by Johnson & Johnson. The maximum daily dose was changed from 8 pills (4,000 milligrams) per day to 6 pills (3,000 milligrams) per day. The drug company also changed the dosing interval from every 4-6 hours to every 6 hours.

An update from the FDA was issued this past January asking health care professionals to stop prescribing and dispensing painkillers that exceed 325 mg of acetaminophen. In the same release, the FDA reported 50% of manufacturers followed the FDA's request to lower acetaminophen, moving forward the FDA will begin proceedings to withdraw approval of any drug products that still remain on the market containing too much acetaminophen.

Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much. In an effort to improve regulation of OTC products the FDA is holding a public hearing today and tomorrow to obtain information and comments from consumers. 

Hepatitis C And Acetaminophen
Generally experts agree low dosages of acetaminophen can safely be used in most patients with chronic hepatitis C infection. According to the Veterans Affairs website (updated July 30, 2013) the maximum recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C is two grams or (four 500mg tablets) per day, but people with cirrhosis should use only one gram or two 500mg tablets per day. It goes without saying, people who actively consume alcohol should avoid taking acetaminophen altogether.

Of Interest

Cirrhosis - Warning About NSAIDS
According to this publication by the University of Michigan health System, patients with cirrhosis should avoid pain medications called “non‐steroidal anti‐inflammatories (NSAIDS)” which include over‐the‐counter medications such as ibuprofen (Motrin, Advil), naprosyn (Aleve), as well as some prescription medications.

Additional Reading

March 2014
Acetaminophen Toxicity: What Pharmacists Need to Know
Acetaminophen-induced liver toxicity has become the most common cause of acute liver failure and the second most common cause of liver failure requiring transplantation.10,11 Therefore, it is imperative that pharmacists recognize signs and symptoms of overdose and toxicity, and counsel their patients on proper dosing and usage.

Although progress has been made, some things are still to be determined. The FDA Advisory Committee has voted in favor of many changes thought to improve safety and decrease toxicity, yet the FDA has not yet taken action. For example, while the maximum daily dose of acetaminophen was previously set at 4 g/day, the FDA Advisory Committee suggests decreasing it in an effort to reduce overdoses. It is important to note that some manufacturers have already updated their labeling to reflect these recommendations, although it is not yet mandatory to do so. Efforts are also being made to improve product labeling, enhance patient education, create a universal pediatric formulation, eliminate acetaminophen combination products, and reduce the strength of OTC acetaminophen products to 325 mg per tablet with a maximum single dose of 650 mg. While no final consensus on any of these issues has been reached, healthcare providers should educate their patients on the importance of following labeling instructions.......

OTC Drug Dangers You Should Know About
Michael Lynch, MD, medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, sees many patients who take OTC drugs for something other than their main intended use. “A common one I hear is people taking Tylenol PM just to sleep,” said Dr. Lynch. “But that also has acetaminophen in it; and if you’re taking too much, it can lead to toxicity.”

How to protect your liver when taking prescription and over-the-counter medications, herbal remedies or other drugs
The liver is the body's clearinghouse for most drugs, herbal remedies, vitamins and supplements which means it is vulnerable to the toxic consequences of inadvertent overdoses, unexpected interactions or extended use. View the following tips to help safeguard your liver health and ensure that the medications and remedies you need to take achieve their desired effect......

Bottom Line
The FDA reported;  most cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products. 

Make sure you take your prescription and over-the-counter (OTC) medicine properly, read the package insert or label in order to calculate your daily intake of acetaminophen.  As mentioned, remember that many narcotic combination pills and over-the-counter cold and flu medications contain acetaminophen.

For important information check out;, a website ran by the Acetaminophen Awareness Coalition, which offers information on some 600 medications that contain acetaminophen.

While you're there play the "Game of Life" and test your "Acetaminophen Knowledge." 

Stay healthy!

Tuesday, March 4, 2014

Your Liver Delivers - Protect It From Harm

Your Liver Delivers - Protect It From Harm

Your liver works hard to protect your health. It’s a rugged, strong organ. But certain things—like alcohol, drugs, viruses, and excess weight—can damage it. You may not even realize when your liver is struggling, because liver disease usually has no symptoms until the problem becomes severe. Help your liver to guard your health by avoiding the things that might cause it harm.

The liver is the largest organ inside your body. It’s about the size of a football, and rests just under your ribs against the right side of your stomach.

“The liver performs an amazing set of functions that keep you healthy,” says Dr. Jake Liang, a liver specialist and researcher at NIH.

Your liver helps fight infections. It cleans your blood by getting rid of your body’s natural waste products and other harmful substances, including alcohol and drugs. “The liver also transforms the foods you eat into energy and nutrients your body can use, and it regulates how nutrients flow to different parts of the body when needed,” Liang says.

Your liver can keep working even if part of it is damaged or removed. But if it starts to shut down completely—a condition known as liver failure—you can survive for only a day or 2 unless you get emergency treatment.

Many things can affect liver function. Some liver problems are inherited from your parents, some are caused by viruses (certain kinds of hepatitis), and some are related to your behavior. Certain liver diseases go away on their own. Others can last a lifetime and cause serious illness.

Although liver disease often has no symptoms, warning signs can include a swollen abdomen, nausea, itching, or jaundice (having a yellow tint to the skin and the whites of the eyes).

NIH supports large research networks across the country to learn more about liver disease. For instance, teams of scientists nationwide have joined forces to study rare and often-deadly liver disorders that strike newborns and older children.

“Research networks are important because no single medical center has enough patients with rare diseases to do a rigorous study or test new treatments,” says Dr. Edward Doo, a liver disease expert at NIH. “With this large pediatric network, we can combine the efforts and expertise of many clinical centers that specialize in rare childhood liver diseases.”

Other NIH studies are focusing on an increasingly common type of liver disorder—known as fatty liver disease—that affects both children and adults. A healthy liver contains just a little fat or none at all. But too much fat buildup in liver cells can cause swelling and damage. Over time, the excess fat can lead to cirrhosis, liver cancer, and even liver failure.

“Estimates vary, but 2 different studies in the past decade suggest that about 30% to 45% of Americans have excess fat in the liver,” says Dr. Yaron Rotman, an NIH specialist in fatty liver disease. “It’s also becoming a huge problem for children and teens.”

Drinking too much alcohol can cause fatty liver. But a growing number of people who drink little or no alcohol are also being diagnosed with fatty liver. “The rise seems to be tied to the nation’s obesity epidemic,” says Doo.

Studies suggest that fatty liver disease now also affects about 1 in 10 children nationwide. As with adults, most children with fatty liver disease are overweight and resistant to insulin, a critical hormone that regulates energy.

In its early stages, fatty liver disease usually has no symptoms. It’s often first detected by blood tests for liver function. But these tests can’t tell the difference between mild fatty buildup and more serious damage. And some people with fatty liver disease can have normal blood tests. The only sure way to diagnose the severity of fatty liver disease is by getting a liver biopsy. For this test, a doctor inserts a thin needle through the skin and into the liver to remove a small piece of tissue for analysis.

NIH-funded scientists have been searching for simpler ways to measure the severity of fatty liver disease. They’re also conducting clinical studies to assess possible treatments. There are currently no approved medications for fatty liver or its more severe form called NASH, or non-alcoholic steato-hepatitis.

“To treat fatty liver disease, we recommend lifestyle changes: Weight loss for people who are overweight, and exercise and a healthy diet to help reduce fat,” Rotman says. “In many patients, just a 5-8% reduction in body weight will translate into a large improvement to liver damage.” For people with alcohol-related fatty liver, stopping alcohol use can reverse or prevent further liver injury.

Another common type of liver disease—known as viral hepatitis—can be caused by at least 5 different viruses, named hepatitis A, B, C, D, and E. These infections can injure your liver and keep it from working properly.

“Collectively, about 20% of people worldwide may be affected by a hepatitis virus infection,” Liang says. “It’s a major public health problem.” The most common types in the United States are hepatitis A, B, and C.

Each hepatitis virus causes a different form of liver disease. All the viruses can trigger acute, or short-term, hepatitis. Hepatitis B, C, and D can also cause chronic hepatitis, in which the infection lasts a long time, sometimes for your whole life.

People are often exposed to hepatitis A and E viruses through contaminated food or water. “The other hepatitis viruses often pass through some type of break in the skin barrier, sometimes by injections or by close contact with blood or other body fluids,” Liang adds. Hepatitis B, C, and D can spread through sexual contact.

Because many infected people have few symptoms, they may not realize they have viral hepatitis. They can spread the infection to others without even knowing it.

Viral hepatitis is often treated with antiviral medications. Hepatitis A, B, and D infections can be prevented by vaccines. Practicing good hygiene—such as washing your hands and avoiding contact with infected blood—can also help block the spread of viral hepatitis.

Another potentially dangerous type of liver disease can be caused by taking certain drugs or supplements. “It’s important to be aware that a lot of drugs can cause liver injury,” Liang says. “This especially can be a problem for people who are taking several different medications.”

Taking too much acetaminophen (Tylenol) is the most common cause of sudden liver failure. “It’s particularly dangerous if you mix alcohol with acetaminophen or certain other drugs,” Liang adds. Talk with your doctor or pharmacist about all the medications you take and how they might affect your liver.

Maintain a healthy weight, stay physically active, and limit your alcohol use. Keep your liver healthy, and it will protect you for a lifetime.

Check out the March issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research

Thursday, February 20, 2014

Lessening liver damage - Possible improved treatment for acetaminophen poisoning

Lessening liver damage

Scientists believe they’ve found improved treatment for acetaminophen poisoning

February 19, 2014

By Joseph Caputo, Harvard Correspondent

B. D. Colen/Harvard Staff

The human liver can safely process up to 4 grams (8 pills) of acetaminophen, best known as Tylenol, over 24 hours. Surpassing that amount risks poisoning or killing liver cells.

Harvard stem cell scientists studying the effect of nitric oxide on liver growth and regeneration appear to have serendipitously discovered a markedly improved treatment for liver damage caused by acetaminophen toxicity, the root of half of the hospital visits involving acute liver failure in the United States.

The human liver can safely process up to 4 grams (8 pills) of acetaminophen, best known as Tylenol, over 24 hours. Surpassing that amount risks poisoning or killing liver cells. Accidental acetaminophen overdoses commonly occur when people who feel sick but don’t know the dangers posed by the over-the-counter pain and fever reducer exceed the safe dosage. Such poisoning kills hundreds of people each year.

Writing in the journal Cell Reports, the researchers described how nitric oxide, which is commonly used to relax cardiac blood vessels in patients with heart disease, enhances liver growth and regeneration, independent of its effect on blood vessels. Using zebrafish and mice, the research team also showed how manipulating these pathways with drugs could improve treatment of toxic liver injury caused by acetaminophen overdose.

The only federally approved treatment for acetaminophen toxicity, N-acetylcysteine (NAC), is most effective if a patient seeks medical help within 8 to 12 hours of overdose. Unfortunately, most overdose-specific symptoms, such as confusion and intestinal bleeding, don’t occur until the liver injury is critical.

“We tried to model that in our studies where we gave fish Tylenol first, waited 18 hours, and gave them a new nitric oxide-based drug combined with the clinically approved drug,” said study co-senior author Wolfram Goessling of the Harvard Stem Cell Institute. “These drugs worked together to improve liver injury even when out of the previously established therapeutic window, and so we think there’s significant potential for clinical application.”

Goessling and his research associates happened upon the nitric oxide-liver injury connection while investigating the signaling pathways that are important for liver development. Goessling’s lab, which he shares with study co-senior author Trista North, screened thousands of known drugs on zebrafish embryos to see which produced a bigger or smaller liver. The compounds with the most dramatic effect were a family of drugs that affect nitric oxide and nitric oxide signaling.

Andrew Cox, a postdoctoral fellow in Goessling’s lab, conducted a series of experiments to show that nitric oxide enhanced liver formation during organ development in zebrafish and that blocking nitric oxide led to smaller, less-developed livers. Further investigation found that nitric oxide worked through different pathways in the liver than it did in the blood vessels, where its ability to regulate blood flow has been well established.

“During these experiments, we found a recently recognized pathway, called protein nitrosylation, where the activity of proteins gets changed by nitric oxide,” Goessling said. “We think that’s the basic principle behind how it works in liver development.”

The members of Goessling and North’s lab found it was possible to enhance liver growth and regeneration by disrupting the nitrosylation pathway so that nitric oxide could better change proteins in the liver. They found a nitrosylation enhancer currently used in clinical trials for other purposes and began testing it in clinical models of illnesses such as Tylenol overdose, where it proved successful.

“This potential drug doesn’t only work in fish,” Goessling said. “We did use mouse models to show that this might have relevance to human disease.”

If the nitrosylation drug for liver toxicity reaches clinical trials, it would join a handful of other drugs developed from zebrafish research that originated from Harvard Stem Cell Institute labs.

Last year, a compound discovered by North and Goessling while they were working as postdoctoral fellows in the lab of Leonard Zon was found to expand cord blood during hematopoietic stem cell transplants in a Phase 1b clinical trial. Another drug for melanoma, also discovered in the Zon lab, reached the federal Food and Drug Administration approval process in 2011.

The research was funded by a Harvard Stem Cell Institute junior faculty grant, a Public Health Service grant, the Pew Charitable Trusts, and an American Liver Foundation Postdoctoral Research Fellowship award

Tuesday, January 14, 2014

FDA asks doctors to limit acetaminophen in combination drugs

FDA asks doctors to limit acetaminophen in combination drugs

Reuters - U.S. health regulators recommended on Tuesday that healthcare professionals stop prescribing combination drugs that contain more than 325 milligrams of acetaminophen per tablet, capsule, or other dosage unit, citing the risk of liver damage.

Limiting the quantity per dosage unit will reduce the risk of inadvertent overdose, which can lead to liver failure, liver transplant and death, the Food and Drug Administration said. It cited the fact that no available data showed that taking more than the recommended dose provided benefits that outweighed the added risks. (

Inadvertent overdose from combination drugs containing acetaminophen, also known as paracetamol in most countries outside the United States, accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, the agency said.

Combination acetaminophen products are commonly prescribed to patients to treat pain from acute injuries, post-operative pain, or pain following dental procedures.

In January 2011, the FDA asked manufacturers of combination drugs containing acetaminophen, sold globally under trade names such as Tylenol and Panadol, to limit acetaminophen doses to no more than 325 mg in each tablet or capsule by January 14, 2014.

Some of these products still remain available, the agency said.

The FDA also suggested that pharmacists who receive a prescription for a combination product with more than the recommended dose contact the prescriber to discuss using a lower dose.

In the near future, the FDA plans to institute proceedings to withdraw approval for combination drugs that remain on the market, it said in a statement.

Acetaminophen, one of the most commonly used drugs in the United States, is widely used in both prescription and over-the-counter products to reduce pain and fever.

(Reporting by Natalie Grover in Bangalore. Editing by Andre Grenon)

FDA Alert:

FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers


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. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. 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.

In January 2011 we asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

More than half of manufacturers have voluntarily complied with our request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available.

In the near future we intend to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

Cases of severe liver injury with acetaminophen have occurred in patients who:
took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
took more than one acetaminophen-containing product at the same time; or
drank alcohol while taking acetaminophen products.

Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. We will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

Health care providers and pharmacists who have further questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or

Related Resources:
Acetaminophen Withdrawal Request Letter [template] [DOC - 44KB]

Federal Register notice: Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From Unintentional Overdose
Don’t Double Up on Acetaminophen

Saturday, January 4, 2014

How to use acetaminophen safely, from the January 2014 Harvard Men's Health Watch

How to use acetaminophen safely in people with HCV

Hepatitis C Review - Acetaminophen -Tylenol
The maximum recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C is two grams (four 500mg tablets) per day....

Evaluation, Staging, and Monitoring of Chronic Hepatitis C
Based on available information and recognition that many patients with chronic hepatitis C have limited pain treatment options, most experts believe that low dosages of acetaminophen can safely be used in most patients with chronic hepatitis C infection. Specifically, patients without cirrhosis can take acetaminophen if they limit their intake to two grams per day; those with cirrhosis should limit their intake of acetaminophen to one gram per day....

How to use acetaminophen safely from the January 2014 Harvard Men's Health Watch

Acetaminophen Safely - The Average Healthy Adult

January 2014

Cold, cough, and flu season is a good time to revisit the risks of acetaminophen, a medication found in many cold, cough, and flu remedies. Although billions of doses of acetaminophen are consumed safely every year, some people taking the drug end up in the emergency room or need hospitalization, and some die from acetaminophen overdose or interaction. In the January 2014 issue of the Harvard Men's Health Watch, Dr. Melisa Lai Becker, an instructor in medicine at Harvard Medical School, suggests some ways to avoid getting into trouble when taking acetaminophen.

Acetaminophen is the chemical name for the widely used pain and fever reliever in Tylenol and other over-the-counter medications. High doses of acetaminophen can inflame and damage the liver. Because acetaminophen is in more than 600 different medications, it can be easy to get more than is healthy.

"People don't realize that these doses all add up, and before you know it you've exceeded the recommended dose of acetaminophen," says Dr. Lai Becker, director of the Division of Medical Toxicology at Harvard-affiliated Cambridge Health Alliance.

For the average healthy adult, the generally recommended maximum daily dose is no more than 4,000 milligrams (mg) from all sources. But in some people, doses close to the 4,000 mg daily limit could still harm the liver. It's safest to take only what you need, and not to exceed 3,000 mg a day whenever possible.

Dr. Lai Becker suggests these guidelines for taking acetaminophen safely:

Stick to recommended doses. When taking acetaminophen, don't be tempted to add a little extra to the recommended dose. A small-bodied person should stay on the low end of the recommended dose range (3,000 mg).

Cold and flu remedies count. When you reach for an over-the-counter cough, cold, or flu product, take a look at the label. Does it contain acetaminophen? If so, add the dose to your daily total.

Know your pills. Over-the-counter acetaminophen pills may contain 325, 500, or 650 mg of the drug. Be extra cautious when taking the 500 or 650 mg pills.

Go easy on alcohol. Drinking alcohol causes the liver to convert more of the acetaminophen you take into toxic byproducts. Men should have no more than two standard drinks per day when taking acetaminophen, women no more than one.

Beware of medication interactions. Ask your doctor or pharmacist if any of your prescription medications could interact badly with acetaminophen.

Acetaminophen: How much can you take safely? 
325 mg 500 mg 650 mg extended release
Take how many pills at a time? 1 or 2 1 or 2 1 or 2
Take how often? Every 4 to 6 hours Every 4 to 6 hours Every 8 hours
Safest maximum daily dose
for most adults
8 pills 6 pills 4 pills
Never take more than this in a 24-hour period 12 pills (3900 mg) 8 pills (4000 mg) 6 pills (3900 mg)

The maximum daily dose for a healthy adult who weighs at least 150 pounds is 4,000 milligrams (mg). However, in some people, taking the maximum daily dose for extended periods can seriously damage the liver. It's best to take the lowest dose necessary and stay closer to 3,000 mg per day as your maximum dose. If you need to take high doses of acetaminophen for chronic pain, check with your doctor first.

Read the full-length article: "Acetaminophen safety: Be cautious but not afraid"

Monday, November 4, 2013

AASLD-Label Warnings Not Enough to Protect Consumer Safety When Taking Acetaminophen

Tylenol and Alcohol a Bad Mix, Study Suggests

Taking the recommended dose of Tylenol, also known by its generic name acetaminophen, combined with a small to moderate amount of alcohol produces a 123 percent increased risk of kidney disease, according to a new preliminary study.

"Most people take this medication without any input from pharmacists or physicians, and that's where the public-health concern is," said lead researcher Harrison Ndetan, an associate professor for research and biostatistics at Parker University in Dallas. "People buy acetaminophen over the counter, and they also are casual alcohol users, and they don't know that there is a harmful interaction."

The study, scheduled for presentation Monday at the American Public Health Association's annual meeting in Boston, establishes only an association between an acetaminophen-and-alcohol combination and increased risk for kidney disease, not a direct cause-and-effect relationship.

Chronic acetaminophen use and chronic alcohol abuse both have been separately linked to kidney and liver disease, said Dr. Martin Zand, medical director of the kidney and pancreas transplant programs at the University of Rochester Medical Center in New York.

"What has not been well-studied until now is the link between some regular alcohol use and regular acetaminophen use and increasing your risk of kidney disease above the risk of either of those used separately," said Zand, who was not involved in the new research.

For the study, researchers analyzed data from more than 10,000 people who participated in the 2003-04 U.S. National Health and Nutrition Examination Survey. It included questions about alcohol consumption, use of acetaminophen and health problems.

The study found that neither normal use of acetaminophen nor light to moderate drinking posed a potential threat to kidneys.

Nearly half of the people who combined the two, however, reported health problems related to their kidneys, the researchers said. Specifically, of the 2.6 percent who took the combination, 1.2 percent reported kidney dysfunction. 

Alcohol can interfere with the gene that regulates the way the body processes acetaminophen, Ndetan said, adding that this is the most likely potential explanation for the association found in the study.

The warning label included on acetaminophen packaging does say not to take the medication with alcohol, Ndetan said, "but it is important for people to receive this message because people will take them despite those warnings."

It's not known if similar interactions occur with other painkillers, he said.

In general, people who regularly consume one should not use the other, Zand said.

If you take acetaminophen daily for chronic pain, you should avoid alcohol, he said. If you drink alcohol regularly, you should try another painkiller or avoid over-the-counter pain medications altogether.

"I'm not suggesting people should not use acetaminophen and should not appropriately and modestly consume alcohol," Zand said. "But it's not a good idea to take acetaminophen for a number of days in a row and then drink alcohol."

So what about taking acetaminophen for a hangover?

"If you do need to take something for pain and if you are not a regular drinker, it would seem to be OK to take some acetaminophen for it," Zand said. "Assuming your kidneys are fine, you might want to choose another painkiller if you want to err on the side of caution, because you've just put your liver through a stress test and it needs all the breathing room it can get to recover."

Research presented at meetings is typically considered preliminary until published in a peer-reviewed medical journal.

AASLD Press Release

Label Warnings Not Enough to Protect Consumer Safety When Taking Acetaminophen

Acetaminophen is the leading cause of acute liver failure in the US. In January 2011, the Federal Drug Administration asked manufacturers to limit the strength of acetaminophen in prescription drug products. They also requested a Boxed Warning for severe liver injury to be added to the label of all prescription drug products that contain acetaminophen. The American Association for the Study of Liver Diseases (AASLD) has been a long-time proponent of these and other measures to improve the safety of acetaminophen, which if used properly, is a safe and effective drug.

Researchers from Northwestern University and Emory University concluded in a recent study that use of an enhanced icon on medication labels and additional written information were insufficient in ensuring the safe use of acetaminophen products. The study of enhanced communication strategies between healthcare providers and patients was conducted between August 2012 and February 2013. Patients at the general medicine clinics were either provided the usual care; provided enhanced bottle labeling with an with an icon identifying acetaminophen as an active ingredient and a flyer to explain safe use of the product (written strategy); or enhanced labeling, written brochure, and added verbal counseling (written and verbal strategy).

Patients in either of the enhanced information groups (written, written and verbal) were more likely to identify acetaminophen as an active ingredient. Only the verbal counseling strategy improved the understanding of the risk of concomitant use with other acetaminophen-containing products. Neither strategy improved understanding to greater than 50 percent. According to Marina Serper, MD, "The strategies we used were supposed to simulate what a patient may encounter in a typical pharmacy when picking up a prescription or choosing an over-the-counter product. We were somewhat surprised that these strategies improved comprehension but not to levels above 50 percent."

The study concluded that additional public health measures are needed to ensure the safe use of acetaminophen. "Acetaminophen is widely prescribed and is available in multiple over the counter products," said Dr. Serper. "Results of this study highlight the public's lack of knowledge of the potential dangers of acetaminophen and that broader public health campaigns may be needed to raise public awareness."

Dr. Serper also had some comments for healthcare providers, "We recommend that healthcare professionals routinely obtain detailed medication histories from their patients, counsel them on the maximum safe daily dose of acetaminophen, and the risks of combining multiple
acetaminophen-containing products."

Abstract title:
Effect of Enhanced Risk Communication on Patient Comprehension of Concomitant Use Warnings for Acetaminophen-Containing Products: A Randomized Trial


AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Photo Credit -

Saturday, September 28, 2013

Watch: Alcohol, Acetaminophen, Liver, Cirrhosis and Transplant

Alcohol, Liver, Cirrhosis and Transplant
by Joe Galati, M.D    on 09/26/2013

A segment that I recorded for this weeks Your Health First was with Dr. Howard Monsour who’s the Chief of hepatology at Houston Methodist. In this two-part interview, we discussed various aspects of alcoholic liver disease, effects of acetaminophen on the liver, and the difference between men and women in their alcohol consumption. As noted in prior posts, the issue of liver transplant in patients with alcoholism and alcoholic cirrhosis is controversial, but when carefully reviewed, their outcomes following transplant are equal or better than other diseases we transplant livers for.

The Blog of Dr. Joseph S. Galati

Monday, September 23, 2013

Behind the Numbers: Acetaminophen poisoning the active ingredient in Tylenol

Behind the Numbers

by T. Christian Miller and Jeff Gerth
ProPublica, Sep. 20, 9:55 a.m.

We explore the data behind figures showing how many people die from overdosing on acetaminophen, the active ingredient in Tylenol.


How many people in the United States die or suffer serious harm from acetaminophen overdose?  
To try to answer this question, ProPublica examined three sets of primary data, as well as dozens of scientific studies. While the data sets varied on the total number of deaths, all three showed an increase in acetaminophen-linked fatalities over much of the past decade, with only occasional year-to-year declines.  
Here is an in-depth look at the numbers.  
Data compiled by the U.S. Food and Drug Administration has linked as many as 980 deaths in a year to drugs containing acetaminophen. In addition, FDA reports of death associated with acetaminophen have been increasing faster than those for aspirin, ibuprofen and many other common over-the-counter pain medicines.  
Data obtained from the U.S. Centers for Disease Control and Prevention show that more than 300 people die annually as a result of acetaminophen poisoning.

Continue reading @ ProPublica

Friday, August 2, 2013

FDA Warns of Rare Acetaminophen Risk-linked to rare fatal skin reactions

Good Morning Folks,
Yesterday the FDA warned consumers that Tylenol and other medicines to treat colds, coughs, headaches, and sleep aids that contain the ingredient acetaminophen can cause a potentially deadly skin rash known as Stevens-Johnson Syndrome, see the warning below, and Medscape article here.

As a reminder to the HCV community in 2012 Vertex Pharmaceuticals revised the INCIVEK® (telaprevir) label to include a Boxed Warning stating that fatal and non-fatal serious skin reactions were reported in patients taking INCIVEK. According to a statement from Vertex, "Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified."

Serious skin reactions include; drug rash with eosinophilia (a higher than normal level of white blood cells called eosinophils) and systemic symptoms (or DRESS) and Stevens-Johnson Syndrome (SJS). Read the FDA Drug Safety Communication/Data Summary here.

Consumer update;

FDA Warns of Rare Acetaminophen Risk

Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

On this page:
Ingredient Linked to Several Conditions
Evidence of Link

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines. Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names. It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

"This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications," says Sharon Hertz, M.D., deputy director of FDA's Division of Anesthesia, Analgesia and Addiction. "However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal."

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word "acetaminophen" appears on the front of the package and on the Drug Facts label's "active ingredients" section. On prescription medications, the label may spell out the ingredient or use a shortened version such as "APAP," "acet," "acetamin" or "acetaminoph."

Ingredient Linked to Several Conditions

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

A serious skin reaction can occur at any time, even if you've taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

If you've ever had a skin reaction when taking acetaminophen, don't take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

Evidence of Link

Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen. In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA's strongest warning, used for calling attention to serious risks.

The agency continues to consider the benefits of this medication to outweigh the risks.

"FDA's actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen," says Hertz. "Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it."

This article appears on FDA's Consumer Updates page4, which features the latest on all FDA-regulated products.
August 1, 2013

Related Aug 2
Acetaminophen Linked to Fatal Skin Reactions
“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications. However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal,” said Dr. Sharon Hertz, the deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction in a statement.

For More Information 

Acetaminophen Information

FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings

Acetaminophen Awareness Coalition’s Know Your Dose Campaign

FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen

Questions and Answers: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen

Monday, July 22, 2013

FDA Voice -Reminds Consumers to Use Acetaminophen Safely

Posted on July 18, 2013 by FDA Voice  
By: Dale Slavin, PhD

On several occasions, the FDA has asked its expert advisory committees for advice about acetaminophen, which is used to treat pain and fever. Based on this advice and extensive review of the available scientific evidence, the FDA continues to believe that acetaminophen’s benefits outweigh its risks. With that said, however, no medicine is without any risk, and that includes acetaminophen.

Hundreds of over-the-counter (OTC) and prescription medicines contain acetaminophen. Many people taking these products may not be aware they contain this active ingredient. Taking too much acetaminophen can damage your liver. So it’s important to check your products, both OTC and prescription, before taking to see if they contain acetaminophen and to make sure you know how to take safely.

It’s important to know what’s in your medicine so you don’t take more than one medicine containing acetaminophen at the same time by mistake. Acetaminophen can be found alone in OTC products, or in combination with other ingredients. The OTC products that combine acetaminophen with other ingredients often treat the pain and fever that come with conditions like a cold and the flu.  In prescription medicines, acetaminophen is combined with other ingredients to help relieve moderate to severe pain.


Each year, hundreds of people suffer from liver damage associated with taking too much acetaminophen.  Symptoms of acetaminophen overdose may take several days to appear, and the symptoms may seem like the flu or a cold.

To make sure you don’t get too much acetaminophen, look at the labels of all the medicines you plan to use. On OTC medicines the word “acetaminophen” appears on the front of the package and on the Drug Facts label under the “Active Ingredient” section. On prescription medicines, the label may spell-out “acetaminophen” or have a shortened version of it, such as “APAP,” “acet,” “acetamin,” and “acetaminoph.” If you aren’t sure if your medicine contains acetaminophen, ask your health care professional for help.

To help avoid the risk of liver damage, make sure you understand the information provided on the medicine label or the directions given by your health care professional. You’ll need to know:
  • How much you can take at one time
  • How many hours you must wait before taking another dose
  • How many times you can take it each day
  • When you should not take it and when to talk to your health care professional
  • On children’s OTC medicines, the “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give based on his or her age.  If a dose for your child’s age is not listed or you can’t tell how much to give, ask your health care professional what to do.
Acetaminophen can be safe and effective when you use it as directed. Following these tips and remembering to never take – or give – more than one medicine containing acetaminophen in the same day will help lower the risk of liver injury.

And if you do take too much acetaminophen, get medical help right away, even if you don’t feel sick. Call the National Poison Control Center at 1-800-222-1222 or 9-1-1.

For more information on the safe use of acetaminophen and other common pain relievers and fever reducers, visit and

Dale Slavin, PhD, is Acting Director of FDA’s Safe Use Initiative