Showing posts with label tylenol. Show all posts
Showing posts with label tylenol. Show all posts

Saturday, November 3, 2012

Acetaminophen: Effect on Drinkers' ALT Levels Appears Safe

Acetaminophen: Effect on Drinkers' ALT Levels Appears Safe


SAN DIEGO – Giving acetaminophen to patients who reported consuming ethanol did not adversely affect markers of liver damage in a meta-analysis of randomized, controlled trials.

"One of the questions we often get asked is the role of acetaminophen in patients with liver disease," according to Dr. Kennon J. Heard, who is an emergency medicine physician at the University of Colorado and director of the Medical Toxicology Fellowship at the Rocky Mountain Poison and Drug Center, Denver.

The findings of the meta-analysis suggest that "acetaminophen is safe in alcoholics," Dr. Heard said at the annual meeting of the Society of Hospital Medicine.

 The meta-analysis included five trials involving 901 subjects (including patients who reported drinking ethanol) who were randomized to receive acetaminophen or placebo.

Dr. Heard and his associates looked at daily ALT measurements out to a mean of 4 days, a time period for which most of the studies had data.

They also looked for any evidence of liver injury or dysfunction, hepatotoxicity, or death.
The alanine aminotransferase (ALT) levels changed by a mean of 0.04 IU/L after starting acetaminophen or placebo, "less than a tenth of a point in ALT," reported Dr. Heard.

"Essentially, in this group of patients who consume alcohol, if you give them acetaminophen for 4 days, you don’t see any change in their ALT," according to Dr. Heard.
The study is to be published in the journal Pharmacotherapy.
When acetaminophen consumption continued beyond 4 days, ALT levels increased in most patients who consumed alcohol but also increased in 60% of nondrinkers.
"The changes in the alcoholics look exactly like the changes in the nonalcoholics," he said.
The median increase in ALT was between 10-20 IU/L.
Among patients who drink alcohol, the highest ALT level in the acetaminophen group was 312 IU/L, "which is pretty impressive until you see that in the placebo group, somebody went up 288" IU/L, he said.
The biggest increase in ALT was in a healthy nondrinking patient on acetaminophen, whose ALT increased by 638 IU/L.
Most importantly, none of the 551 people who received acetaminophen in those trials developed an increase in International Normalized Ratio, bilirubin level, or symptomatic liver injury, Dr. Heard and his associates found.
Dr. Heard said that he and his associates are now in the process of finishing a separate study that appears to confirm that these are asymptomatic, self-limiting elevations in ALT that will go away even if people stay on acetaminophen.
Such information is valuable, he said. "It is worth knowing that if you have someone who has an ALT elevation while taking acetaminophen, it may be the cause, and it is reasonable to stop the acetaminophen and see if their ALT elevations go away rather than do an extensive work-up for hepatitis," Dr. Heard said.  

More Clinical News »

Tuesday, June 5, 2012

Parents Should Be Aware Of Life-Threatening Accidental Acetaminophen Overdosing In Children

Acetaminophen, a widely available over-the-counter medication, can cause liver toxicity in children if doses are exceeded, and more public education is needed to warn of potential adverse effects, states an article published in CMAJ (Canadian Medical Association Journal).

"Acetaminophen overdose is a major cause of acute liver failure and is the most common identifiable cause of acute liver failure in children," writes Dr. Rod Lim, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario, with coauthors. "Repeated supratherapeutic dosing [above the recommended dose], accidental overdose due to error and intentional ingestion can all result in acute liver failure and even death."

The authors cite a case study of a 22-day-old baby in which the parents misunderstood the correct dose of acetaminophen and administered too much analgesic for a circumcision. After the procedure, when the doctor instructed the parents to give another dose, they discovered the error. In this case, N-acetylcysteine with dextrose was given intravenously, and the child recovered within about 24 hours after ingesting the medication.

N-acetylcysteine is the standard treatment for liver toxicity related to an overdose of acetaminophen and is usually successful if started within eight hours after ingesting the drug.

Medication errors involving children are a serious issue, and dosing is complicated by the need to dose by the child's weight and convert this dose to a volume because many medications for children are in liquid form. A report from the US poison control centres and the American Academy of Pediatrics, which analyzed 238 instances of serious medication errors in children under age six, found that 11% of children who are given pharmaceuticals experience a medication error such as an incorrect medication, incorrect dose or method of administering. Acetaminophen overdose was the most common single agent responsible for a life-threatening event, longer-term illness or death.

A better approach is needed to prevent these avoidable, and life-threatening, errors.

"Although physicians and pharmacists should continue to educate parents and caregivers regarding the medications prescribed, one-to-one communication cannot be the sole approach to reducing errors in medication administration," write the authors. "Error reduction on a large scale requires systems-based interventions and prevention."

Suggestions include better labelling and dosing information, improved dosing devices - many parents use spoons, which are not standard sizes and can lead to overdoses - and placing acetaminophen behind the counter to ensure that a pharmacist can counsel parents on correct dosing.

Wednesday, May 30, 2012

Study uncovers the extent of OTC acetaminophen overdose risk

New York / Heidelberg, 30 May 2012

Misuse of over-the-counter pain medication is potential health threat

11606_204x153Study uncovers the extent of OTC acetaminophen overdose risk

A significant number of adults are at risk of unintentionally overdosing on over-the-counter (OTC) pain medication, according to a new study in the US by Dr. Michael Wolf, from Northwestern University in Chicago, and his colleagues. Their work¹, looking at the prevalence and potential misuse of pain medication containing the active ingredient acetaminophen as well as the likelihood of overdosing, appears online in the Journal of General Internal Medicine², published by Springer.
Many adults in the US regularly use OTC pain medication containing the active ingredient acetaminophen, the most commonly used OTC pain medication in the US. They take it either on its own or in combination with other drugs, which may also contain acetaminophen. The ease of access to OTC drugs presents a challenge to patient safety as many individuals may lack the necessary health literacy skills to self-administer these medicines appropriately. Indeed, individuals make independent decisions that match an OTC product to a self-diagnosed symptom or condition. Worryingly, acetaminophen overdose is the leading cause of acute liver failure.
Wolf and colleagues interviewed 500 adult patients receiving care at outpatient general medicine clinics in Atlanta and Chicago between September 2009 and March 2011. Over half the patients reported some acetaminophen use and 19 percent were 'heavy users' i.e. they had taken it every day, or at least a couple of times a week, during the previous six months.
The researchers tested whether these patients understood the recommended dosage and were able to self-administer OTC acetaminophen appropriately. Firstly, could they work out the proper dosing of a single OTC medication over a 24-hour period? Secondly, what was the risk of patients 'double-dipping', or simultaneously taking two acetaminophen-containing products, and thereby exceeding the recommended dose?
To assess proper dosing, the participants were given five OTC drug bottles and, for each one, were asked to imagine that they took the first dose at time X, and wanted to take the maximum dose of this medicine in one day. They were then asked to show the researcher how many pills and at which times they would need to take them for a full 24-hour day.
To assess 'double-dipping', the patients were told to imagine they were taking a maximum dose of a primary OTC drug and asked whether it would be safe to also take a second medicine with the primary medicine - both of which contained acetaminophen.
Wolf and team found that nearly a quarter of the participants were at risk of overdosing on pain medication using a single OTC acetaminophen product, by exceeding the dose of four grams in a 24-hour period; 5 percent made serious errors by dosing out more than six grams. In addition, nearly half were at risk of overdosing by 'double-dipping' with two acetaminophen containing products.
The authors conclude: "Our findings suggest that many consumers do not recognize or differentiate the active ingredient in OTC pain medicines, nor do they necessarily closely adhere to package or label instructions. Given the prevalence of the problem, risk of significant adverse effects, and lack of a learned intermediary i.e. a physician to guide decision making and counsel consumers on proper use, we believe this to be a serious public health threat requiring urgent attention."
1. Wolf MS et al (2012). Risk of unintentional overdose with non-prescription acetaminophen products. Journal of General Internal Medicine; DOI: 10.1007/s11606-012-2096-3
2. The Journal of General Internal Medicine is the official journal of the Society of General Internal Medicine.
The full-text article is available to journalists on request.
DDW-Patients May Receive Too Much Acetaminophen in Hospital

Wednesday, May 23, 2012

DDW-Patients May Receive Too Much Acetaminophen in Hospital

WEDNESDAY, May 23 (HealthDay News)

Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according to a new U.S. study.

Patients on more than one drug containing acetaminophen often consume more than the recommended 4 grams per day of the drug, the researchers from Thomas Jefferson University Hospital in Philadelphia found.

Together, two tablets of extra-strength Tylenol contain 1 gram of acetaminophen, commonly used to relieve pain and reduce fever.

Over the course of two years, researchers led by Dr. Jesse Civan examined 46,000 hospital admissions and the medications those patients were given. They found that on at least one day of hospitalization, roughly 1,100 patients received more than 4 grams of acetaminophen in the form of Tylenol, Percocet and similar drugs.

The study authors also assessed the effects the acetaminophen had on the patients' livers and found only a small minority were given a blood test to check their liver function. The investigators noted that this test is typically used only when a doctor has a specific concern about possible problems with a patient's liver.

In the small number of patients who did have the blood test of liver function, the researchers noted that there were no serious liver injuries. They said there wasn't enough information to determine if abnormal test results were the result of excessive exposure to acetaminophen.

Civan and colleagues concluded that more research is needed to determine if new recommendations for the safe daily dosing of acetaminophen are necessary. They added that patients need better education on acetaminophen safety, particularly for use of the drug after they leave the hospital, when patients may try to duplicate the medications and doses they were given during their admission.

The study was presented Monday at the Digestive Disease Week meeting in San Diego. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information
The U.S. Food and Drug Administration has more about acetaminophen.

Dr. Orman will present these data on Monday, May 21 at 4 p.m. PT in Halls C-G of the San Diego Convention Center.

Patterns of Usage of Acetaminophen in Excess of Four Grams Daily in a Hospitalized Population at a Tertiary Care Center (Abstract #743)

Hospitalized patients who receive multiple orders of medication containing acetaminophen are likely to receive a higher than intended dose of the drug, even when provided by physicians, according to new research from Thomas Jefferson University Hospital, Philadelphia, PA.

Reviewing 46,000 hospital admissions over a two-year period, investigators led by Jesse Civan, MD, GI fellow, division of gastroenterology, Thomas Jefferson University Hospital, found that about 1,100 individuals received more than 4 grams of acetaminophen on at least one day. In other words, about 2.5 percent of all patients admitted to the hospital received more than what is currently considered the safe cumulative daily dose on at least one calendar day.

Investigators sought to determine exactly how much acetaminophen was being dispensed in a large tertiary-care hospital and how it compared to the generally accepted safe maximum dose. They reviewed a computer database tracking every patient admitted to their hospital and every dose of medicine prescribed and received. This allowed them to calculate exactly how much medication patients were exposed to, including any medication containing acetaminophen, such as Tylenol®, Percocet® and other similar medicines, and to generate a list of all patients who received more than 4 grams of acetaminophen on at least one calendar day.

Researchers also reviewed liver function and injury, which are reported in the same database, to determine potential detrimental effects of acetaminophen use on patients. By reviewing a specific blood test — the alanine amino-transferase (ALT) test, which is generally used to screen for liver injury possibly related to acetaminophen — Dr. Civan and his colleagues found that only a small minority of patients were administered an ALT test. They attribute this finding to the fact that the blood test is only usually checked when a physician is particularly concerned about a possible liver problem. 

In the small minority of patients who did have an ALT checked, there was insufficient data to do a “formal cause analysis” to determine whether an abnormal ALT could be blamed on the acetaminophen exposure. Because of the paucity of ALT monitoring, no conclusion could be reached about whether the acetaminophen exposure might have had any detectable detrimental consequences.

Dr. Civan added that these findings could have implications on public health and the need to improve patient education regarding safe dosages at home, since many patients will likely attempt to emulate the medications provided at the hospital once they get home. He concluded that further study in this closely monitored population in which every dose of acetaminophen-containing medication administered is recorded might shed light on the ongoing discussion at the U.S. Food and Drug Administration and elsewhere regarding new recommendations for maximum safe daily dosing. Dr Civan stressed that although it remains unclear whether blood test abnormalities may have resulted from acetaminophen use, he did not find any evidence of any cases of serious liver injury.

Acetaminophen has been under increasing scrutiny in the U.S. — it is the leading cause of acute liver failure and emergent liver transplant, and previous studies have suggested that unintentional overdose is a significant problem. There has also been debate in the medical literature about whether a less severe form of acetaminophen-induced liver injury due to unintentional overdose may be important.

Thursday, March 29, 2012

Hepatitis C Review - Acetaminophen -Tylenol

Hepatitis C Review - Acetaminophen -Tylenol 
In 2011 Johnson & Johnson reduced the maximum daily dose of its Extra Strength Tylenol pain reliever, lowering the risk of accidental overdose from the drugs active ingredient acetaminophen.

Today on the blog those label changes are highlighted with the hepatitis C patient in mind.

Stay updated by viewing future articles related to - Acetaminophen Safety.

What We Know
For the average healthy person acetaminophen-Tylenol is a remarkably safe and effective drug when taken at the recommended dose, yet acetaminophen has caused hundreds of deaths per year.

The Answer
In November of last year MSNBC author Rachel Rettner wrote an article about a study published in the British Journal of Clinical Pharmacology . The study found that "staggered overdoses" of acetaminophen were more deadly than single overdoses. The journalist explains:

The study looked at what are called "staggered overdoses," in which a person repeatedly exceeds the daily recommendation through small overdoses. This is in contrast to the more familiar single overdose, when a person takes too many pills at once.

In the study, staggered overdoses of acetaminophen  (which is found in Tylenol and other pain reliever's) were more deadly than single overdoses, even though people who experienced staggered overdoses typically took smaller total amounts of acetaminophen than those who experienced a single overdose.
Doctors may not identify staggered overdoses right away, researchers added. People with a staggered overdose may have levels of the drug in their blood below what a standard blood test would indicate as an overdose, even when their liver is badly damaged.

In a related article at TIME  journalist  Maia Szalavitz reported the highest health risks from "staggered overdose" were seen in older people and people who drink a lot of alcohol.

Heavy drinkers and older patients were at highest risk of staggered overdose. Alcohol alone can damage the liver and those who drink more than three drinks a day are advised not to use drugs that contain acetaminophen.
People who misuse opioid painkillers are also at risk of staggered acetaminophen overdose because common opioid drugs like Vicodin include it. While long-term users develop tolerance to the effects of the opioid component of these drugs, this does not affect the potential of acetaminophen to damage the liver.

In  January of 2011 the FDA  asked acetaminophen-manufacturers to lower the strength of acetaminophen in prescription drug products to 325 milligrams per pill. Although, MSNBC reported taking a pill of this dosage every four hours could still put a person at risk from "staggered overdose" from acetaminophen. As noted below Tylenol was not included in the FDA action.
The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).

OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.

Acetaminophen-ALT elevations in non-drinkers
I thought this was interesting, in 2010 a study published in "The Journal of Human Pharmacology and Drug Therapy" researchers found that daily use of acetaminophen - at the daily maximum dose of 4 g/day for 10 days causes asymptomatic ALT elevations in non-drinkers.

2010 Study/Full Text:
In conclusion, administration of the maximum daily recommended dose of acetaminophen, 4 g/day to healthy non-drinkers for more than 4 consecutive days is associated with asymptomatic ALT elevation in most subjects. ALT elevations are generally between 1.5 and 2 times their pre-treatment measurements are not accompanied by other laboratory findings or symptoms of liver injury and all ALT elevations resolved once acetaminophen administration was stopped.
Hepatitis C And Tylenol

Under the supervision of a doctor, and depending on the condition of the liver, people undergoing HCV therapy are often prescribed Tylenol for joint aches, pain and fever relief, without risk or complications. 

Someone please tell me what is the recommended dose of Tylenol is for people with HCV ?
The Recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C

According to "The Department of Veterans Affairs" website (updated: July 21, 2011) the maximum recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C is two grams (four 500mg tablets) per day.

Tylenol Label Changes
 The Maximum Recommended Dose For "Healthy Patients"

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.

*The 2011 label changes for extra strength Tylenol are listed below, the company says it will cut the maximum dosage of Regular Strength Tylenol and other acetaminophen-containing products in 2012..

* Patients with cirrhosis should avoid pain medications called “non‐steroidal antiinflammatories (NSAIDS)”

Please know with every mention of HCV therapy there are far too many people who have not benefited from new or old drugs that treat this virus. For these people who have advanced liver damage, managing pain or sleep aids can be a daily struggle. Check out the website for an article written by Jennifer Pate, covering the commonly used sleep medications in patients with liver disease
Pain Medications In Patients With Cirrhosis

Patients with cirrhosis should avoid pain medications called “non‐steroidal antiinflammatories (NSAIDS)”. These include over‐the‐counter medications such as ibuprofen (Motrin, Advil), naprosyn (Aleve), as well as some prescription medications. Ask your doctor if any of your medications are NSAIDS.

For mild to moderate aches and pains, it is safe to use Tylenol (acetaminophen) at doses of 2,000 mg/day or less (no more than 6 regular strength or no more than 4 extra strength each day AND no more than 20 regular strength or no more than 15 extra strength each week). Some cold medicines and prescription pain medicines contain acetaminophen, so read the labels and make sure you don’t
take too much by mistake.

Medications - Decompensated Liver Disease 
A 2011 review article published in the International Journal of Hepatology titled:  

Extra Strength TYLENOL New dosing instructions

Once again the new dosing instructions reduce the maximum daily dose from 8 pills per day to 6 pills per day and change the dosing interval for Extra Strength TYLENOL® from every 4-6 hours to every 6 hours. These labeling changes will be consistent across all single-ingredient Extra Strength TYLENOL® products. We are working closely with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions.

Changes affect the labels of the following Extra Strength TYLENOL® products

Extra Strength TYLENOL® Rapid Release Gels - 500 mg in each gelcap

Extra Strength TYLENOL® Caplets - 500 mg in each tablet

Extra Strength TYLENOL® EZ Tabs - 500 mg in each tablet

Extra Strength TYLENOL® Rapid Blast Liquid - 500 mg in each
15 mL = 1 tablespoon

 *Regular strength Tylenol 

*Consider a lower acetaminophen dose found in regular-strength Tylenol, which is 325 mg. It could be adequate enough to relieve minor pain or treatment side effects.

Regular strength Tylenol - 325 mg in each tablet


Regular strength Tylenol

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child take more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
*Ask a doctor before use if the user has liver disease

Extra Strength TYLENOL
Caplets, Rapid Release Gels, EZ Tabs

Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 6 caplets, gelcaps, or tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Rapid Blast Liquid

Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 TBSP) (3 FL OZ) (3,000 mg) in 24 hours. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
****Ask a doctor before use if you have liver disease.

Today, more than 600 over-the-counter and prescription medicines contain acetaminophen.These include medicines to treat symptoms of allergies, cold and flu, and pain with trouble sleeping.

Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions. Acetaminophen –the active ingredient in TYLENOL®–is safe when used as directed, but when taken in overdose amounts, it can cause liver damage.

Some Common Medications That Contain Acetaminophen*
It’s important to be aware of the ingredients in all medications that you may be taking. Acetaminophen (APAP) is a common component of many different over-the-counter and prescription medications. You should not take two or more products that contain acetaminophen at the same time.
Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage.

Some Common Prescription Drugs That Contain Acetaminophen*
  • Darvocet®
  • Endocet®
  • Fioricet®
  • Hycotab
  • Hydrocet®
  • Hydrocodone Bitartrate
  • Lortab®
  • Percocet®
  • Phenaphen®
  • Sedapap®
  • Tapanol®
  • Ultracet®
  • Vicodin®
  • Zydone®

Some Common Over-the-Counter Drugs That Contain Acetaminophen*
  • Actifed®
  • Anacin®
  • Benadryl®
  • Cepacol®
  • Contac®
  • Coricidin®
  • Dayquil®
  • Dimetapp®
  • Dristan®
  • Elixir®
  • Excedrin®
  • Feverall®
  • Formula 44®
  • Goody’s® Powders
  • Liquiprin®
  • Midol®
  • Nyquil®
  • Panadol®
  • Robitussin®
  • Saint Joseph® Aspirin-Free
  • Singlet®
  • Sinutab®
  • Sudafed®
  • Theraflu®
  • Triaminic®
  • TYLENOL® Brand Products
  • Vanquish®
  • Vicks®
  • Zicam®
*This is NOT a complete list.

In addition to the new dosing instructions on the OTC label, the makers of TYLENOL® launched Get Relief Responsibly™, an initiative designed to educate consumers about the appropriate use of OTC and prescription medications, particularly those containing acetaminophen, and the importance of reading and following medication labels. As a part of this initiative, the makers of TYLENOL® have created a new website The site includes an interactive Acetaminophen Finder tool to help consumers identify products that contain acetaminophen and build a personal acetaminophen medication list to share with their healthcare provider or pharmacist.

Related Updates

Thursday, July 28, 2011

J&J cuts maximum Tylenol dose to prevent overdoses

Linda A. Johnson, AP Business Writer, On Thursday July 28, 2011, 3:18 pm

TRENTON, N.J. (AP) -- Johnson & Johnson said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.
The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. -- one of many products in short supply in stores due to a string of recalls.

Starting sometime this fall, labels on Extra Strength Tylenol packages will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day, or 4,000 milligrams. Beginning next year, McNeil will also reduce the maximum daily dose for its Regular Strength Tylenol and other adult pain relievers containing acetaminophen, the most widely used pain killer in the country.
Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.

But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."

Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen.
Then in January, the FDA said it would cap the amount of acetaminophen in Vicodin, Percocet and other prescription pain killers at 325 milligrams per capsule -- just under half the 700 milligram maximum of some products on the market then. The agency also said it was working with pharmacies and other medical groups to develop standard labeling for acetaminophen.
"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, McNeil's head of over-the-counter medical affairs, said in a statement. "McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing."
Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for about 200 fatal overdoses and sends 56,000 people to the emergency room each year.
McNeil spokeswoman Bonnie Jacobs said other makers of pain relievers are likely to make similar changes to their product labels.

Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.

Las Piedras is one of three factories implicated in a series of 25 recalls since September 2009 that have included tens of millions of bottles of Tylenol and other nonprescription drugs, several prescription drugs, hip implants and contact lenses made by Johnson & Johnson.
The recalls, for quality problems ranging from metal shavings and improper levels of active ingredients in some medicines to painfully defective hip implants and packaging with a nauseating odor, resulted in a consent decree with the FDA this spring.
As a result, Las Piedras and a second factory, in Lancaster, Pa., are under additional scrutiny. The third factory, in Fort Washington, Pa., made children's medicines such as liquid Tylenol. It has been closed since April 2010 and is being gutted and completely rebuilt.
Jacobs said the label changes are not related to the recalls.

Saturday, January 8, 2011

A Few Facts On Chronic Liver Disease and Cirrhosis

Information Chronic Liver Disease and Cirrhosis

Patients who suffer from chronic liver disease may develop cirrhosis after years of disease. Cirrhosis of the liver is a serious condition characterized by severe scarring. Not everyone with hepatitis or liver disease develops cirrhosis. If your doctor has told you that you have chronic liver disease and/or cirrhosis, there are important precautions that you should take to prevent further damage to your liver.

Can I drink alcohol?
No, you should not drink alcohol.

Alcohol damages liver cells. A healthy liver is able to replace most liver cells that are injured by alcohol. However, in individuals with cirrhosis, the liver is unable to replace the damaged liver cells. Drinking any alcohol, not just hard liquor, but also beer or wine will speed up the process of liver destruction and may counteract any treatments prescribed by your doctor.

Sensitive to medications

Cirrhosis slows the liver's ability to filter medications from the blood. Because the liver does not remove drugs from the blood at the usual rate, they act longer than expected and build up in the body. This causes a person to be more sensitive to medications and their side-effects.

Is it safe to take acetaminophen (Tylenol ®)?

Patients with cirrhosis can safely receive between 2 grams (2000 mg) and 3 grams of acetaminophen daily for longer than two weeks, and individuals with and without cirrhosis using alcohol regularly can safely receive up to 4 grams on a short-term basis, according to Mayo Clinic researchers

(Mayo Clin Proc2010;85:451-458).

Acetaminophen is the main ingredient in Tylenol ®, but it is also found in many non-prescription products for headaches, the flu, sinus problems, arthritis or general aches and pains. In 1993, an FDA Advisory Committee recommended that all over-the-counter pain relievers contain an alcohol warning. Tylenol and some other pain relievers have included such an alcohol warning on their labeling. But, not all over-the-counter pain relief products have complied with the FDA recommendation. There have been some reports that chronic heavy alcohol users may be at increased risk of liver toxicity from excessive acetaminophen use.
Pay particular attention to products labeled "aspirin-free"; because some prescription medications also contain acetaminophen, so be sure to ask your doctor about use of pain relievers.

Some Acetaminophen Containing Medicines

People with alcoholic liver disease or cirrhosis should use no more than 4 tablets (2 grams or 2000 mg) a day. If there is any uncertainty, always check with your physician.

Tylenol ® 325 mg/tablet
Tylenol Extra Strength ® 500 mg/tablet
Tylenol Adult Liquid ® 500 mg/tablespoon
Tylenol Extended Relief ® 650 mg/tablet
Aspirin Free Excedrin ® 500 mg/tablet
Excedrin Extra-Strength ® 250 mg/tablet
Excedrin P.M. ® 500 mg/tablet
Midrin ® 325 mg/capsule
Actifed Cold & Sinus ® 500 mg/tablet
Sinutab Sinus Allergy ® 500 mg/tablet
Sudafed Cold & Cough ® 500 mg/tablet

What other medications should I avoid?
You may need to avoid iron supplements. Too much iron can damage liver cells or aggravate liver damage caused by some viruses. Most adults do not need to take iron supplements unless there is a history of obvious blood loss or a known deficiency of iron. Unless your doctor prescribes iron supplements for you, do not take any iron supplements or even multivitamins that contain iron.

What foods should I avoid?
Sewage runoff can infect edible sea organisms (clams, oysters, crustaceans and fish) with both bacteria and viruses. Contamination of seafood may be undetectable by smell or taste. Clams and oysters are especially susceptible to sewage contamination and should never be eaten raw.

Vibrio vulnificus is a bacteria that is found in contaminated oysters and other seafood. In healthy people, it rarely causes serious infection, but in individuals with cirrhosis it can cause death in 48 to 72 hours.

Hepatitis A is a virus that can be found in clams and oysters. Infection with hepatitis A can cause even healthy persons to become very sick. Individuals with cirrhosis are especially vulnerable to a life-threatening infection caused by this virus.

If you have open sores on your skin, you should avoid exposure to sea water during the warm summer months. Harmful organisms can enter the blood stream through these sores and cause serious infection.

Are vaccines important?
Yes. Ask your doctor if you would benefit from one or more of the following vaccines:

Hepatitis A Vaccine:
Used to prevent hepatitis A, which can be severe in individuals with cirrhosis. It consists of a series of two injections given six months apart.

Hepatitis B Vaccine:
Used to prevent hepatitis B, another type of viral hepatitis. It consists of a series of three injections. The second and third injections are given one and six months after the initial injection.

Pneumococcal vaccine:
Used to prevent a kind of pneumonia caused by a bacteria called Streptococcus pneumoniae. It consists of only one injection, and should be repeated in five years.

Flu Shot:
Used to prevent influenza, a cause of severe upper respiratory infection and pneumonia. It is a single injection given yearly, usually in the Fall, just prior to the flu season.
Are there any natural herbs that can heal my liver?

Many causes of cirrhosis do not have any treatment available. For this reason, many individuals resort to the use of "health foods" and "natural herbs or supplements" to improve the liver. There is no scientific proof that any of these products are of benefit to the liver. Most of them are safe, but liver damage caused by herbal products has been reported. There are several herbal remedies that are known to cause liver damage. Be sure to tell your doctor before you begin any herbal products so that he or she may better monitor your condition.

People with cirrhosis may or may not have symptoms early in the course of the disease. Some of the more common symptoms include:

Enlarged Spleen
Normally, blood from the intestines and spleen is carried to the liver through the portal vein. But cirrhosis slows the normal flow of blood, which increases the pressure in the portal vein. This condition is called portal hypertension. When portal hypertension occurs, the spleen frequently enlarges and holds white blood cells and platelets, reducing the numbers of these cells in the blood. A low platelet count may be the first evidence that a person has developed cirrhosis.

Also See: Cirrhosis: What Happens When The Spleen Is Enlarged ?

Scarring makes it difficult for blood to flow through the liver. As a result, veins in other areas outside of the liver become abnormally expanded. Abnormally expanded blood vessels are referred to as varices.

When the liver slows or stops production of the proteins needed for blood clotting in patients with cirrhosis they have easy bruising and bleeding. Once bleeding starts (such as with variceal bleeding), it can be severe.

One place where varices are commonly found is in the esophagus, the swallowing tube connecting the mouth with the stomach (figure 2).

When the pressure in the varices reaches a certain level, the varices can burst, which can cause massive bleeding (known as variceal bleeding).

( figure 2)
Cirrhosis can cause the blood vessels around the esophagus to swell. This is called "esophageal varices". In severe cases, these blood vessels can burst and cause internal bleeding.
Body fluids accumulate as a result of liver scarring and a decreased ability to manufacture blood proteins. Fluid is typically seen in the legs (edema) and abdomen (ascites) and sometimes in the lung (pleural effusion).

Symptoms of edema depend upon the cause, but may include:

Swelling or puffiness of the skin, causing it to appear stretched and shiny. This is typically seen in the lower legs (called peripheral edema) or lower back (called sacral edema, frequently seen in those with edema who have been in bed for long periods). Swelling is often worst after sitting or standing for a period of time (due to gravity), and may be worse at the end of the day. Pushing on the swollen area for a few seconds will leave a dimple in the skin
(picture 1)

Treatment of edema includes several components: reducing the amount of salt (sodium) in your diet, and in many cases, use of a medication, called a diuretic, to eliminate excess fluid. (additional information below)

Ascites causes the abdomen to enlarge as fluid accumulates, which can cause shortness of breath and a feeling of fullness. The fluid provides an environment where bacteria can grow, increasing the risk of infection.

Patients with cirrhosis have a weakened immune system and are at increased risk of infections.
Spontaneous bacterial peritonitis is an infectious form of peritonitis (inflammation of the abdominal cavity) that affects 10 to 30 percent of people hospitalized with ascites.
Spontaneous bacterial peritonitis can cause:
· rapid acceleration of liver disease
· other complications
· sepsis (whole body infection)
· death

A dangerous result of fluid buildup in the abdomen, spontaneous bacterial peritonitis is the most common infection in patients with ascites from cirrhosis, and it strikes without any identifiable external source of infection.

Hepatic encephalopathy is a condition that develops when the liver is unable to break down toxins normally found in the bloodstream, such as ammonia. In this condition, confusion or even coma are caused by toxins that build up in the blood. In the early stages, there may be mild symptoms, such as difficulty sleeping or sleeping too much. Advanced hepatic encephalopathy can cause confusion, delirium, and even coma. Hepatic encephalopathy can develop suddenly and may become a medical emergency.

Malnutrition is common in patients with cirrhosis a damaged liver cannot properly metabolize many of the nutrients that an individual consumes in his or her diet. Patients are often malnourished for any of a number of reasons (eg, ongoing ethanol use, chronic nausea, anorexia, fat malabsorption, meal-induced abdominal discomfort, dietary protein restriction).

Malnutrition can lead to proximal muscle wasting, hypoalbuminemia with worsening of ascites, neutropenia with decreased resistance to bacterial infections, and weak cough with predisposition to pneumonia. Weakened connective tissue may predispose to variceal hemorrhage, umbilical hernia, and other complications. Because of these concerns, adequacy of the diet should be a major focus in the cirrhotic patient.

Aside from sodium restriction in patients with ascites, physicians try to not restrict the diet of patients with cirrhosis, even in the setting of hepatic encephalopathy. Routine supplementation with thiamine, folate, calcium, and a therapeutic multivitamin is appropriate. Some authorities recommend avoiding supplemental iron because excess absorption may contribute to liver injury.

Many people with advanced cirrhosis have jaundice (yellowed skin or whites of the eyes).
People with cirrhosis are at increased risk for developing liver cancer (hepatocellular carcinoma).
Cirrhosis can cause fatigue and in some cases itching.

Signs Of Compensated Liver disease
In hepatitis C infection about 20 percent of people develop cirrhosis. Once your liver has reached this stage cirrhosis commonly occurs in two stages, compensated and decompensated. In the first stage of liver damage, the liver still has the ability to function normally or compensate for the damage. When extensive damage occurs and the liver can no longer function normally, decompensation occurs. According to the Hepatitis C Trust, up to 80 to 90 percent of the liver becomes permanently damaged before decompensated occurs.

The signs of compensated cirrhosis include a large, hardened liver, small, star-shaped vessels (spider angiomata) on the skin of the upper torso, blotchy redness on the palms (palmar erythema), whitened nails, thin silky hair, loss of body hair, prominent veins on the abdomen (abdominal collateral veins), irregular or absent menstruation in pre-menopausal women, and small testes and enlarged, sometimes painful breasts (gynecomastia) in men.

Signs Of Decompensated Cirrhosis
The signs of decompensated cirrhosis include all the above except that the liver may be shrunken and there may be swelling of the legs (edema), accumulation of fluid in the abdomen (ascites), bleeding from veins in the esophagus (varices), and mental confusion (hepatic encephalopathy) and jaundice.
Most chronic liver disease damages the liver over time by forming scar in the liver that replaces normal liver tissue. When there is enough scar, we call this cirrhosis. Cirrhosis is an advanced form of scarring or liver damage. However, even a cirrhotic or badly scarred liver can often still perform all the functions that a liver needs to do and in fact, it often continue to perform these functions quite well even for decades. This is because we are all given excess liver capacity which allows the liver to function well even if a significant amount of the liver is damaged.

When a liver is diseased or cirrhotic but is still functioning well we say this is compensated liver disease. This is a critical distinction because many people with hepatitis C will have cirrhosis but have no signs of liver failure. We call this compensated cirrhosis. Many of these people will be stable for years and many will be candidates for therapy. They typically do not have to be considered for liver transplant unless the liver starts to fail or their disease “decompensates”.

However, when the liver starts to fail with chronic liver disease, it almost never happens suddenly, unless some one is drinking heavily or gets another insult to the liver like hepatitis A.
People with chronic liver disease feel because they feel fine one day and then be close to death the next , that they quickly went into liver failure. This is not the way things work. In fact, typically, liver specialists can start to see signs of liver failure in tests months or years before the patients themselves notice them.

General Health With Cirrhosis
General health in patients with cirrhosis should not be neglected. For example, dental care is important to correct periodontal disease that may lead to abscesses. Diabetes mellitus occurs with increased frequency in patients with hepatitis C or hemochromatosis, and complications of diabetes may add to the risk of liver transplantation. Many patients who have cirrhosis smoke cigarettes, which increases the risk for atherosclerotic disease and chronic lung disease, lung cancer, and squamous cell cancers of the head, neck, and esophagus, patients should be strongly encouraged to quit smoking.

Certain classes of medications have the potential to aggravate complications of cirrhosis and are best avoided or used with caution. These include aminoglycosides, which increase nephrotoxicity; angiotensin-converting enzyme inhibitors, which can cause hypotension; nonsteroidal anti-inflammatory drugs, which promote renal sodium retention; and sedative and narcotic agents, which precipitate hepatic encephalopathy.

Drugs that are eliminated by the liver must be used in low doses in patients who have cirrhosis. This is particularly true of drugs that undergo high first-pass hepatic clearance, because portosystemic shunting greatly increases their bioavailability. Potentially hepatotoxic medications present a difficult problem.

In patients with cirrhosis the early signs of hepatotoxicity can be difficult to identify. The consequences of hepatotoxicity superimposed on cirrhosis can be devastating.


Dietary Factors
Healthy Foods. Because important antioxidant vitamins are depleted in the cirrhotic liver, cirrhosis patients should maintain a diet rich in fresh fruits, vegetables, and whole grains.
Antioxidant Supplements.

There is some preliminary laboratory evidence that various antioxidant supplements including vitamin E, selenium, and S-adenosylmethionine (SAMe) may help protect against liver damage and cirrhosis. Supplements, however, are not recommended for people with liver disease except with the advice of a physician. Some vitamins, such as vitamins D and A, are metabolized in the liver and can be toxic.

Iron Restrictions.
Elevated iron levels have been associated with cirrhosis from many causes. Patients should avoid iron-rich foods, such as red meats, liver, and iron-fortified cereals and should avoid cooking with iron-coated cookware and utensils.
Supplemental Nutritional Products.

Supplemental nutritional beverages may be helpful, particularly for patients with both alcoholism and cirrhosis. In one study, patients with both alcoholism and cirrhosis drank Ensure every day as a supplement to their regular diet. After six months they showed significant improvement in many signs of overall health compared to those who didn't consume the beverage. Vitamin B1 (Thiamine). Thiamine binds to iron and helps reduce iron load in the liver. One small study suggested it may be helpful for patients with chronic hepatitis B. It is not known if it has any benefit for cirrhosis. Pork is high in the vitamin, but more healthful sources include dried fortified cereals, oatmeal, corn, nuts, cauliflower, sunflower seeds and vitamin pills.

Omega-3 Fatty Acids.
Some research suggests that supplements of omega-3 fatty acids (found in fish oil and evening primrose oil) may help protect the diseased liver. Protein and Soy. High-quality dietary protein may be especially helpful for patients with ascites and for repairing muscle mass, but excessive protein loads may trigger encephalopathy. Protein solutions have been devised that provide beneficial amino acids without including those that increase this risk. There is no limit on vegetable proteins, such as those from soy.
Salt Restriction.

Restricting salt consumption to less than 2,000 mg a day is particularly important for patients with ascites. The less salt the better. Zinc. In some studies, taking zinc supplements have lowered ammonia levels in some patients who were zinc-deficient, a common problem in cirrhosis. Zinc replacement may reduce frequency and severity of muscle cramps and may even help protect against encephalopathy.

Limiting Fluids
Fluid restriction is not usually necessary, but patients with severe ascites should discuss limiting fluid with their physicians.

Exercise increases the risk for portal pressure and variceal bleeding. One study reported that taking a beta-blocker may reduce this risk, although patients should discuss this with their physician.

Preventing Influenza and Infections
Infections can have a severe impact on the liver. Although most respiratory infections generally affect only the lungs, one small study suggested influenza may directly affect the liver in patients with cirrhosis and exacerbate the disease process. Researchers in the study advise annual flu shots for people with cirrhosis. Furthermore, they advise that patients who get the flu be treated immediately with rimantadine, but not a similar treatment called amantadine.
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