Tylenol and Acetaminophen Liver Risks Results in FDA Reminder

Federal health regulators issued a reminder this week about the potential liver risks with Tylenol and other acetaminophen products, indicating that consumers should carefully monitor the amount of acetaminophen they take from a number of medications that contain the active pharmaceutical ingredient.

In an FDA Voice blog post on July 18, Dale Slavin, PhD, who is the Acting Director of the FDA’s Safe Use Initiative, highlighted the risk of liver failure consumers may face from taking Tylenol or hundreds of other over-the-counter and prescription medications that contain acetaminophen.

Slavin reminds consumers that it is important to know what is in medications, so that multiple acetaminophen-based drugs are not used at the same time.

“Each year, hundreds of people suffer from liver damage associated with taking too much acetaminophen. Symptoms of acetaminophen overdose may take several days to appear, and the symptoms may seem like the flu or a cold,” the blog post notes. “To make sure you don’t get too much acetaminophen, look at the labels of all the medicines you plan to use.”

In addition to Tylenol and other over-the-counter cold and flu products, acetaminophen is often used in prescription painkillers in conjunction with other ingredients, usually opioids. Over-the-counter products will have “acetaminophen” on the front of the package and in the Active Ingredients area of the Drug Facts section on the label. In prescription drugs, the label will likely have the word acetaminophen or an abbreviated version, such as APAP, acet, acetamin, or acetaminoph.

Patients with questions should check with their health care provider or pharmacist if they are unsure if a drug has acetaminophen or if they are uncertain how much is safe for them to take.

Federal health officials have previously recognized that acetaminophen overdose is the leading cause of liver injury in the United States, causing more than 50,000 emergency room visits each year, including 25,000 hospitalizations and 450 deaths.

In recent years, increased efforts have been focused on raising awareness about the risk of overdosing on acetaminophen or Tylenol, in an attempt to reduce the number of liver failure cases nationwide, which often result in the need for a liver transplant.

Johnson & Johnson lowered the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day in 2011, after the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet.

Tylenol Liver Failure Lawsuits

Although Tylenol is one of the most widely used pain medications in the country, and is generally assumed to be safe by consumers, Johnson & Johnson faces an increasing number of liver failure lawsuits involving Tylenol, which allege that the drug maker has attempted to minimize the liver risks with Tylenol and failed to adequately warn consumers about the risk of accidental overdose.

Concerns about the risk of liver problems from Extra Strength Tylenol have focused on the narrow margin between the recommended daily dose and the risk of liver toxicity, since 500mg of acetaminophen are contained in each tablet. Some estimates have suggested that nearly a quarter of users may take more than the recommended dose, which could result in small, accidental Tylenol overdose, which may go untreated and increase the risk of liver failure or death.

Since the U.S. Judicial Panel on Multidistrict Litigation established consolidated proceedings in the federal court system for all Tylenol lawsuits filed throughout the country, more than 80 cases have been transferred to the U.S. District Court for the Eastern District of Pennsylvania. However, it is expected that the size of the Tylenol litigation will continue to grow over the coming months, and ultimately hundreds, if not thousands, of cases may be filed nationwide on behalf of individuals who suffered liver failure after using Tylenol.