Unintentional Acetaminophen Overdose Risks Highlighted in New Report

A new report released by a group of health care providers and consumer watchdog groups seeks to warn consumers about the dangers of acetaminophen and Tylenol overdose, highlighting the importance of increased education about how to avoid potentially fatal liver damage. 

The report is titled “Acetaminophen: How It’s Used, Preventing overdose and What We Can Do To Promote Safe Use” (PDF), and was released last month by the Acetaminophen Awareness Coalition (AAC).

The group highlights dosing behaviors that can lead to overdoses, and provides new data on the widespread use and misuse of the popular painkiller.

“Though total instances are rare in the context of the ingredient’s widespread use, acetaminophen overdose is the leading cause of acute liver failure in the United States,” the report states. “While the majority of these overdose-related liver failure cases are intentional (i.e., suicide or suicide attempt), nearly half are associated with unintentional overdoses—people accidentally exceeding the total 4,000 mg daily dose by not reading or following dosing instructions and taking multiple acetaminophen-containing medicines at the same time, taking too much at one time, and/or redosing too soon.”

The ACC is made up of a number of medical and consumer watchdog groups, including the American Association of Nurse Practitioners, the American Pharmacists Association and the National Consumers League, among others. The group maintains that it believes most acetaminophen products are safe when used accordingly.

Tylenol is one of the most widely used painkiller medications in the United States, which has been used by millions of Americans. The medication is perhaps the best known brand that contains acetaminophen as the active pharmaceutical ingredient, which has been identified in recent years as a leading cause for liver injury in the United States.

According to the report, about 26,000 people are hospitalized every year due to acetaminophen overdoses and they contribute to about 56,000 emergency room visits every year. However, the vast majority appear to be intentional.

The FDA estimates that acetaminophen overdose leads to more than 450 deaths annually. In recent years, efforts have been ramped up to bring the risk of acetaminophen overdose 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.

In addition to Tylenol, acetaminophen is found in more than 600 different prescription and over-the-counter medications and 50 million Americans use medicine containing acetaminophen each week.

To avoid an overdose and liver damage, the report recommends never exceeding the maximum daily dose of 4,000 mg. Those who do overdose unintentionally usually do so by taking the next dose too soon, using multiple drugs containing acetaminophen or by taking too much acetaminophen at one time.

FDA Also Combating Acetaminophen Liver Damage

In late May, the FDA issued a consumer update, warning that there is actually no way to know who will suffer acetaminophen or Tylenol liver damage caused by an overdose.

Critics have warned that while the FDA has taken steps to make sure doctors and pharmacists are aware of the potential liver risks with high-dose acetaminophen products, many consumers continue to believe Tylenol and other over-the-counter products are safe. This could result in consumers suffering catastrophic liver injuries from taking too much Tylenol or combining over-the-counter drugs that contain acetaminophen.

In recent years, increased effort has been focused on raising public awareness about the risk of acetaminophen overdose, but Extra Strength Tylenol and other high-dose products remain available over-the-counter. Given the narrow margin between the recommended dose and a risk of liver failure, critics continue to call for stronger regulatory actions.

In 2011, 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 the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, the drug maker continues to maintain that Tylenol is a safe and effective, and few consumers realize the risk of liver damage that may be caused by taking more than two pills with each dose or failing to carefully monitor the frequency of doses.

Johnson & Johnson currently faces a number of Tylenol lawsuits filed in state and federal courts throughout the country on behalf of former users who suffered liver damage, liver failure or death.

The complaints allege that Johnson & Johnson has built the global impression that Tylenol is safe by withholding information about the potential liver damage risks with acetaminophen for decades. Many of the complaints suggest that the FDA would never approve Tylenol as an over-the-counter medication if it were first introduced today.