Tylenol / Acetaminophen

Tylenol (acetaminophen) overdose may overwhelm 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.

On January 13, 2011, the US Food and Drug Administration (FDA) announced that it was taking steps to cut the risk of Tylenol liver damage and other effects of acetaminophen toxicity. Specifically, the FDA requested all makers of prescription products that contain acetaminophen to limit the amount of acetaminophen to 325 milligrams per capsule or tablet. Drug companies have until January 14, 2014 to reduce the amount of acetaminophen in their products to 325 mg per capsule or tablet.

Furthermore, the FDA requested a Boxed Warning on all prescription acetaminophen products highlighting the risk for severe liver injury and requested a warning on acetaminophen-containing products highlighting the risk of allergic reaction.

In making its announcement, the FDA said it continues to receive reports of severe liver injury associated with products that contain acetaminophen. Overdoses from prescription products containing acetaminophen make up approximately half of the cases of acetaminophen-related liver failure in the US. Acetaminophen-related liver failure can result in liver transplant or death.

In June 2009 a "black box" warning was recommended for prescription medications—such as Tylenol 3 with codeine-- that combine acetaminophen with another drug. An FDA working group studying over-the-counter acetaminophen (including Tylenol) indicated that more stringent warnings about Tylenol liver damage risks are necessary because high doses of acetaminophen can cause serious injuries and other Tylenol side effects. In addition, the use of alcohol together with Tylenol or other acetaminophen drugs could increase the risk of liver failure.

The manufacturer's recommended dosages state that adults should take no more than a total of 4,000 mg of acetaminophen (that means eight 500mg extra strength tablets) a day. The FDA working group recommended that an adult daily dose limit on Tylenol should be decreased to 3250 mg per day, and that pills be capped at 325 mg each. If the FDA's recommendations are adopted, Tylenol and other acetaminophen-based medications would include:

• Warnings that taking more than recommended amounts can cause liver damage
• Warnings that the products should not be combined with other medications that include acetaminophen
• Highlighting acetaminophen as the active ingredient

Acetaminophen overdose is the leading cause of liver failure in the US and the United Kingdom and the leading cause of calls to the Poison Control Centers across the US. It is estimated that acetaminophen poisoning calls exceed 100,000 per year. Studies indicate that acetaminophen overdose results in over 56,000 injuries, 2,500 hospitalizations, and an estimated 450 deaths per year.

People at Tylenol Risk

People consuming three or more servings of alcohol per day should take even less than the FDA's proposed recommended dosage: more than two servings of alcohol per day can increase the risk of liver failure from acetaminophen. People who take Tylenol in high doses, or simply use it regularly are also at risk.

People with decreased liver function, kidney disease, hepatitis, malnutrition, AIDS, chronic ethanol abuse, or anorexia nervosa may be at increased risk for liver failure and death when using Tylenol. For diabetics, acetaminophen may also affect the results of blood glucose (sugar) tests.

Children's Tylenol

Small doses of Tylenol's active ingredient, acetaminophen, have been associated with liver damage and even deaths in children in the US. In 1997 McNeil Consumer Products Company added new labeling to its infant Tylenol, warning that the contents are concentrated acetaminophen and that taking more than the recommended dose could cause serious health risks.

While Tylenol has been on the market for 50 years, many professionals feel that the proper dosage of acetaminophen for children is still unknown and more testing and education is necessary to prevent liver damage and accidental deaths. Many people are confused by packaging directions for Children's Tylenol as they are given by age and weight. And other medications such as cold and sinus medications, which contain acetaminophen, can add to the risk of Tylenol overdose.

McNeil's Children's and Infants;Tylenol Melt aways and Soft Chews have been associated with acetaminophen overdose problems. Labeling is confusing: The design of the Melt away and Soft Chew packages include some blister voids that contain one tablet while some others contain two per void. Consumers may believe that two tablets provide a total of only 80mg when two tablets are really a total of 160mg which, when consumed by a child, can lead to Tylenol over-dosing.

Children's Tylenol Recall In September 2009 McNeil Consumer Healthcare (Johnson & Johnson) issued a voluntary recall of some its Children and Infant Liquid Tylenol Products that were manufactured between April of 2008 and June of 2008. The products may potentially be contaminated with harmful bacteria.

The following products have been recalled:

• Children's Tylenol Cold MS Suspension 4 oz. Grape
• Children's Tylenol Plus Cough & Runny Nose 4 oz. Cherry
• Infant's Tylenol Suspension Drop 1 oz. Grape

The manufacturer announced that B. cepacia bacteria were discovered in some of the unused raw material for an inactive ingredient in these products.

If your child has developed a serious medical injury from taking one of these defective Tylenol products, you may be eligible to receive compensation for your damages. Tylenol Asthma

Asthma is the leading cause of chronic illness in children. It affects about 10 to 12 percent of children in the US and it is steadily increasing. Asthma can begin at any age (even in the very elderly), but most children have their first symptoms by age 5.

The exact reasons why more and more children are developing asthma are still unknown. Some experts suggest that children spend too much time indoors and are exposed to more dust, air pollution, and secondhand smoke. Some suspect that children are not exposed to enough childhood illnesses to direct the attention of their immune system to bacteria and viruses. Now, research indicates that Tylenol may be linked with an increased risk of asthma in children and adults.

Researchers found that acetaminophen users were 63 percent more likely to have asthma than nonusers. They also found the following:

• 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.