Tylenol (also known by its generic names, acetaminophen and paracetamol), is a popular over the counter medication for pain relief. Acetaminophen first gained FDA approval in 1951 and in 1955, Tylenol, the most popular form of acetaminophen came to market. It is commonly used to relieve headaches, migraines, osteoarthritis pain as well as fever. It is also found in many cold and flu formulations. It may also be prescribed post-surgery for pain management. It is now the most commonly used pain and fever reliever used in the United States. In 2005, 29 billion units of prescription and over the counter acetaminophen-containing products were sold. Over the counter medications contain dosage strengths between 325mg and 500mg, with a recommended single dose up to 1000mg. It is estimated that 23% of all American adults use acetaminophen in any given week.Tylenol Side Effects: Problems That Arise with Tylenol
Though many people believe that Tylenol is safe, as it has been marketed to be an alternative to ibuprofen with fewer side effects, serious adverse effects have been reported. In 2010, a study was published that linked its use during pregnancy to male infertility in the adult life of the unborn. One of the most serious adverse effect associated with Tylenol is the risk of liver injury. Other possible adverse effects include the risk of blood cancer in adults and development of asthma and eczema when used in very young children.
Tylenol/acetaminophen overdose has become a burden on the already strained American healthcare system. It is estimated that on a yearly basis 56,000 emergency room visits and 26,000 hospitalizations are due to acetaminophen overdose. Furthermore, it is reported that nearly 500 deaths annually are attributed to overdose. Acetaminophen is one of the leading causes of liver failure in the United States, accounting for approximately half of all liver failures annually, more than any other single cause. In half of these cases, the overdose is unintentional.What the Studies on Tylenol and Liver Damage Are Telling Us
Previous studies had demonstrated that Tylenol in combination with hydrocodone resulted in liver damage. However, it was not until 5 or 6 years ago that this toxicity was identified to be due to Tylenol rather than hydrocodone. A trial was conducted to study the toxicity of hydrocodone but instead found that use of Tylenol led to increased liver enzymes, biological markers of liver damage. This study showed that Tylenol posed the risk, rather than the hydrocodone. A study published in 2005 reported on the prevalence of liver injury due to Tylenol and other acetaminophen-containing products. The study included 662 patients and reported that 27% of patients who overdosed on acetaminophen died without a liver transplant and 8% required a liver transplant.
A recent study, published online (ahead of print) in September reviewed 790,188 patients prescribed acetaminophen between 2001 and 2008. The study classified patients by their potential use as those with use over the recommended prescription dosage of 4,000mg (4g) per day and toxic dose of 10,000mg/day (10g / day). Though the frequency of patients the potential maximum dose exceeding 4g/day had declined from 33% in 2001 to 27% in 2008, the percentage of patients having a potential maximum dose exceeding 10g/day increased from 1.9% in 2001 to 3.2% in 2008.
Though dosages over 10/g per day are typically associated with liver injury in adults, there are reported cases near the recommended maximum daily dosage of 4g. A study in 2006 reported that liver damage can occur at dosages of 4g/day or lower and showed that liver enzymes, early indicators of organ damage, increased in over one-third of subjects.
It has also been shown that alcohol consumption when taking Tylenol can result in liver injury at lower doses. Further, combining products containing Tylenol (ie. prescription medications combined with over the counter Tylenol tablets or cold & flu medications containing acetaminophen) may also increase risk as this increases the total amount of acetaminophen consumed.What the FDA Did About This Concern about Tylenol
In response to the growing body of evidence linking Tylenol and acetaminophen-containing products to liver injury, the FDA took action in 2009, requiring manufacturers of acetaminophen-containing over the counter medications to bear prominent warning labels stating the risk of liver injury. In January of 2011, the FDA limited the amount of acetaminophen in combination prescription drugs to 325mg of acetaminophen (e.g. Tylenol 3 with codeine). This action was taken to make the products safer for use but is being phased in over a 3 year period. This action underscored what Tylenol liver damage attorneys have been saying for years: Tylenol can be dangerous and too many people have liver damage as the result of acetaminophen poisoning.
This ruling also included changes to labels to clearly state the potential risk of severe liver injury. However, this ruling does not address over the counter Tylenol products, many of which contain 500mg to 1000mg of acetaminophen per tablet/caplet. Though FDA has taken some action to reduce the amount of acetaminophen in combination prescription drugs, little action, except addition of warning labels, has occurred with over the counter products such as Tylenol. Though surveys have shown that 95% of respondents read part or all of over the counter medication labels, it is unclear how many are aware of the serious risks of Tylenol and acetaminophen-containing products and the threshold they are not to exceed on a daily basis.The Problem That Remains with Tylenol
It is often left up to the consumer to be vigilant about medication use in order to ensure their well-being. Many times patients prescribed medications containing acetaminophen are not aware that they should not take over the counter products containing acetaminophen at the same time as they are not always informed by their doctor or pharmacist. With many products on the market now containing multiple ingredients, it is important to be aware of ingredients, amounts and total daily intake of certain products such as acetaminophen in order to avoid potentially toxic and fatal effects. This can be extremely difficult in situations where patients may be taking acetaminophen from multiple sources for multiple indications (ie. taking a cold and flu medication with acetaminophen when also using Tylenol daily for joint pain relief).