The Headlines

According to the Journal of the American Medical Association “If you take Tylenol for four days as directed you may be at risk of liver damage.” (1)

“Liver toxicity from acetaminophen poisoning is by far the most common cause of acute liver failure in the United States.” (MedPage Today 2)

“The margin between a safe dose (of Acetaminophen) and a potentially lethal one is small.” (Wall Street Journal 3)

In 2004, William Lee stated in the journal Hepatology, “Acetaminophen (called Paracetamol outside North America) overdose results in more calls to poison control centers in the US than overdose of any other pharmacological substance, accounting for more than 100,000 calls, as well as 56,000 emergency room visits, 2,600 hospitalizations, and 458 deaths due to acute liver failure per year.” (4)

“A study of cases of acute liver failure between November 2000 and October 2004 by the Centers for Disease Control and Prevention in the USA found that paracetamol (acetaminophen) was the cause of 41% of all cases in adults, and 25% of cases in children.” (5)

Norfolk liver specialist, Dr. Michael Ryan, believes it could happen to a lot of people. That’s why he signed a petition asking the FDA to take action; “I don’t think people are aware that acetaminophen is the same as Tylenol. They just think of Tylenol,” said Dr. Ryan.

“Consumers usually have no idea of the toxicity of OTC [over-the-counter] drugs,” said Dr. Walter Peterson, professor emeritus of medicine at the University of Texas Southwestern Medical Center at in Dallas: “They believe that because they are OTC, they are safe.”

Editor’s Note — PainKillerAwareness.org is committed to sharing information we have gathered through extensive analysis of research studies, credible media sources and statistics. Our goal is to provide readers with the information that we gather along with the corresponding source. This will allow our readers to make intelligent and informed decisions about the painkillers they choose to consume. This particular blog post/article is an ongoing article that will have new information added to it as it is discovered or released.  If our readers have important information that is not in this article, we would appreciate it if you would share the information and source with us through our contact page.

The Statistics:

According to the Harvard Medical School, in March 2006, acetaminophen accounted for 458 deaths yearly and this number is on the rise. One of the major factors influencing the increase of accidental overdoses is what some call “drug creep” a dangerous influx of acetaminophen consumption as a result of numerous medications being used to treat a variety of ailments. In the US and the UK acetaminophen is the leading cause of liver failure. Within the US, it is the leading cause of poison control calls.

Acetaminophen Side Effects:

• Abdominal Pain
• Loss of appetite
• Diarrhea
• Nausea
• Convulsions
• Coma
• Vomiting
• Death

An acetaminophen overdose overwhelms the liver’s defenses and cause liver damage or even liver failure. Liver failure can be fatal; the only known cure for acute liver failure is a liver transplant.

FDA:

In early 2011, the FDA became involved and ordered all prescription medications containing acetaminophen to be limited to 325mg. Numerous prescription pain killers such as; Vicodin, Percocet and Lortab are a combination of acetaminophen and other medication. However, this will not be required by law until 2014. The FDA also requested that all prescriptions containing acetaminophen have a box warning stating the risk for liver damage. This warning has also been extended to OTC versions of acetaminophen. The FDA warnings state:

• Taking more than the recommended dose can cause extensive damage to the liver
• Acetaminophen must be highlighted as the active ingredient
• Combining other acetaminophen containing medication can increase chances of acetaminophen overdose.

The FDA reported that it has continued to receive numerous reports of severe injury and liver failure as a result of prescription and over-the-counter acetaminophen. Another vital recommendation from the FDA was to lower the recommended daily dosage for adults. It is suggested that the daily limit be reduced from 4,000 mg (8 extra strength Tylenol) to 3,250 mg of acetaminophen a day (6.5 extra strength Tylenol).

High Risk Factors

• Alcohol consumption: Individuals who consume more than 2 servings of alcohol should only take half of the recommended daily dose.
• High dose users: Individuals who take even one pill more than the recommended dosage increase their risk significantly.
• Regular users: extended usage is a common causation of liver failure.
• Diabetes: diabetic users can experience increased blood glucose (sugar) levels.
• Malnutrition and Anorexia: Malnourishment and acetaminophen consumption has been known to result in increased risk for liver failure even at levels below the recommended dose.
• Current or previous health patients: Individuals who have experienced poor liver function, kidney disease, hepatitis, malnutrition, AIDS, or chronic ethanol abuse have significantly higher chances for overdose.

Children’s Tylenol:

• Acetaminophen has similar effects on children in much smaller doses. In 1997, as a result of numerous deaths of children the McNeil Consumer Products Company added labeling to children’s Tylenol that states one extra dose could cause serious health risks.
• Users have often reported that directions and packaging can be confusing and misleading. Children’s Tylenol Melt Aways and Soft Chews have been directly related to child overdose problems. Also, the weight or age directions have produced significant confusion that has lead to overdosing.
• Experts have found that despite the past 50 years of being sold in drug stores, acetaminophen still needs extensive research before a safe dose for children can be determined. Without this research, children around the world are at risk for severe liver damage and possibility of death.

Is Asthma Related To Tylenol?

• Although asthma has not yet been proven to be directly correlated to acetaminophen, many strong relationships have been found in very large studies. Three of the major studies were 200,000+ participants and over 30+ countries. Proving correlation is a difficult task, however every large research project including a high number of published findings, has found that extensive research must be done in this area due to the repeatedly high level of connection.
• Numerous class action law suits have been filed and won as a result of recalled products.
  • Children’s Tylenol Cold MS Suspension 4oz. grape
  • Children’s Tylenol Plus Cough & Runny Nose 4oz Cherry
  • Infant’s Tylenol Suspension Drop 1oz. Grape
  • Here are the facts: According to “America’s premier online legal news source”, Lawyers and Settlements.com
    • Researchers found that acetaminophen users were 63 percent more likely to have asthma than nonusers.
    • The risk of asthma in children given acetaminophen in the year before their asthma diagnosis was increased by 60 percent.
    • The risk of asthma in children who used acetaminophen in the first year of life was 47 percent higher than in those who didn’t use it.
    • The risk of asthma in adults who used acetaminophen was 74 percent higher than in those who did not.
    • Prenatal use of acetaminophen boosted the risk of wheezing by 50 percent and the risk of asthma by 28 percent in children.
    • The researchers concede that children with severe asthma may be more likely to get acetaminophen for viral or other infections that may actually be due to asthma or may precede an asthma diagnosis. They also stated that acetaminophen use and asthma is an association, but not necessarily a cause and effect and more studies are needed to fully understand the association.  Reported Lawyers and Settlements.com  “America’s Premier Online Legal News Source”