Tylenol is one of the most commonly used drugs in the United States. The active ingredient in Tylenol is a drug called acetaminophen. Acetaminophen-containing products such as Tylenol are used by over 50 million Americans weekly to treat conditions such as pain, fever, and the aches and pains associated with the common cold and flu. If taken at recommended doses, Tylenol (acetaminophen) causes very few side effects; however, taking more than the recommended dose can cause serious liver damage, acute liver failure, and even death. Overdoses can result when patients accidentally take more than the recommended dose of Tylenol (or another acetaminophen product), or by taking over one acetaminophen-containing product at the same time.
Numerous studies have demonstrated that acetaminophen overdose is a leading cause of liver damage and liver failure in the United States, and the FDA notes that “the extent of liver failure cases reported in the medical literature provides an important signal of concern.” The Agency also concedes that ingesting even a small amount of Tylenol (acetaminophen) over the recommended total daily dose may lead to liver injury and even acknowledges that “currently recommended doses and tablet strengths of acetaminophen leave little room for error…”.
In addition to Tylenol, acetaminophen is an active ingredient in over 600 over-the-counter and prescription medications. As such, individuals may inadvertently use over one acetaminophen-containing product at the same time. For example, acetaminophen is a common ingredient in many multiple-ingredient medications, such as Sudafed Triple Action™ and NyQuil. Someone who takes Tylenol for a headache and who subsequently takes one of these combination medications to treat the aches and pains associated with the flu may unknowingly consume more than the recommended daily dose of acetaminophen.
Further complicating the picture for consumers is the fact that acetaminophen may be difficult to identify as an ingredient. Some prescription medications that contain acetaminophen label the ingredient simply as “APAP.” The lack of clear labeling may also lead consumers to accidentally ingest more than one product that contains acetaminophen.
Maximum Daily Dosage
In 2009, an FDA advisory panel recommended dropping the maximum daily dose below the established level of 4,000 mg and also asked the FDA to reduce the single adult dose to 675mg. The FDA chose not to follow the advisory panel’s recommendations. However, in January 2011, the FDA announced a mandate to all manufacturers of prescription acetaminophen combination products (such as Tylenol with Codeine #3) to limit the maximum amount of the ingredient in these products to 325 mg per dosage unit (tablet, capsule, drops, syrups, etc.).
In July 2011, the manufacturer of Tylenol – McNeil Consumer Healthcare – announced that it was voluntarily lowering the maximum daily dose instructions for Extra Strength Tylenol (an over-the-counter best-seller) to six pills a day (3,000 mg) to reduce the risk of acetaminophen overdose. McNeil also announced plans to lower the maximum daily dose for Regular Strength Tylenol and its other acetaminophen-containing products starting in 2012.
Important things you should know:
Signs and Symptoms of Tylenol Liver Damage:
The symptoms associated with Tylenol induced liver injury can take several days to appear, even in severe cases. They may also be non-specific and mimic flu symptoms, making them even harder to identify.
Know your risk: An individual’s susceptibility to livery injury from Tylenol (acetaminophen) varies. People who have increased sensitivity may experience toxic effects at lower doses, as may those who use alcohol or who have pre-existing liver disease. Talk to your doctor if you drink over three alcoholic drinks per day, take the prescription blood thinner warfarin, or if you have liver disease. Even if you take Tylenol (acetaminophen) at the recommended dose, you may still be at an increased risk for liver disease.
Infants and children: Products designed specifically for children (such as Children’s Tylenol and Infants’ Tylenol) contain acetaminophen in different strengths. Liquid formulations designed for infants and toddlers are usually stronger (more concentrated). Those designed for older children are generally less concentrated. Failure to distinguish between the two strengths can cause accidental overdose for younger children and infants.
Advertising tactics: Advertisements for over-the-counter acetaminophen-containing products such as Tylenol frequently emphasize their effectiveness. Unlike prescription medications, these advertisements are not required to offset these messages of warning information about the associated risks. Since the association between acetaminophen and liver damage is not well-known among consumers, consumers may not be fully aware of the potential risks.
Read labels carefully: All medications have a listing of their ingredients on their label. For over-the-counter medications such as Tylenol, refer to the “Drug Facts” label under the section titled “Active Ingredients.” If your medicine contains acetaminophen, you will find it listed there. Prescription medications will contain the ingredient labeled as “acetaminophen” or “APAP.”
If you are considering a potential Tylenol liver damage lawsuit and want a free look at your options, call 800-553-8082 or get a free online consultation.