Consumers Warned About Acetaminophen Overdose, Liver Failure Risks by FDA

Federal drug regulators issued a new warning last week, reminding consumers that acetaminophen, the active ingredient in Tylenol and a number of other cold, flu and pain medications, poses a serious risk of accidental overuse and liver damage.

The U.S. Food and Drug Administration (FDA) issued the “Don’t Overuse Acetaminophen” warning on February 1, highlighting how easy it is to accidentally take too much of the medication when ill, due to its use in hundreds of over-the-counter medications. The agency urges consumers to read the drug labels of every product they use, particularly when suffering from a cold or the flu.

Tylenol and other acetaminophen drugs have been identified by other experts as a leading cause for liver injury, and previous studies indicate that it causes an estimated 50,000 emergency room visits each year in the U.S., including 25,000 hospitalizations and over 450 deaths annually. In addition, use of the medication has been linked to a risk of dangerous skin reactions, like Stephens-Johnson Syndrome.

In recent years, efforts have been ramped up to bring the risk of acetaminophen overdoses to the public’s attention and to reduce the amount of liver injury cases linked to the popular analgesic, which is also found in other pain killers and a number of cold medications.

The FDA warning notes that acetaminophen overdose most often occurs when someone has the flu or a cold, and takes medication to reduce fever and other symptoms, then they also take Tylenol or acetaminophen separately for headaches, often not realizing the durgs contain the same active pharmaceutical ingredient.

The current maximum recommended adult daily dose of acetaminophen is 4,000 milligrams per day, according to the FDA.

“Be cautious not to exceed the daily limit of acetaminophen when using a single medicine or combination of medicines containing this drug. Taken carefully and correctly, these medicines can be safe and effective,” the FDA warning states. “But taking too much acetaminophen can lead to overdose and severe liver damage.”

Symptoms of acetaminophen overdose can include nausea, vomiting abdominal pain, confusion and jaundice, the agency warns. It can take several days for symptoms to appear, and some consumers suffering from overdose may show no symptoms at all. However, when those symptoms become apparent, they may mimic cold and flu symptoms, the FDA notes.

In severe cases, acetaminophen overdose can lead to the need for a liver transplant or result in death, according to the warning.

Widespread Use of Acetaminophen in Drug Products

The FDA notes that there are more than 600 medications, both prescription and non-prescription, that contain acetaminophen. It is used as a fever reducer and relief from pain caused by headaches, muscle aches, menstrual periods, sore throats, toothaches and back pain.

The agency estimates that 1 billion colds are experienced by Americans each year, and about 12% get the flu. About 70% of people use nonprescription medications to treat those ailments, and acetaminophen is often an ingredient in many of the treatments they select.

Exacerbating the problem is that it is often not immediately clear that acetaminophen is an ingredient in many over-the-counter medications. Most people are aware it is the main ingredient in Tylenol, but many are unaware that it is often in other popular cold and flu products.

“When you’re deciding which OTC product to buy, read the Drug Facts label to see if the ingredients include acetaminophen, especially before using two or more products at the same time,” the FDA recommends. “The word ‘acetaminophen’ is not always spelled out in full on the container’s prescription label. Abbreviations – such as APAP, Acetaminoph, Acetaminop, Acetamin and Acetam – may be used instead.”

In 2017, Johnson & Johnson reached a settlement to resolve about 200 Tylenol lawsuits filed over liver damage side effects. The details of the Tylenol liver damage settlement agreement were not disclosed.

Tylenol ADHD and Autism Lawsuits

More recently, the manufacturer also faced about 500 Tylenol lawsuits over claims that using acetaminophen during pregnancy could increase the risk of autism and attention deficit hyperactivity disorder (ADHD) in the mother’s offspring.

However, late last year a federal judge overseeing a Tylenol ADHD and autism multidistrict litigation excluded plaintiffs’ expert witnesses from testifying. The ruling came after the judge determined that the scientific approaches and studies used by the expert witnesses were not sound enough to allow them to be presented to a jury.

This means that currently the plaintiffs have no way to prove causation. Unless the decision is overturned on appeal, it is likely that those cases will be dismissed, ending the litigation.