Tylenol Overdose Risk Is Staggering; Acetaminophen Safeguards Remain Insufficient: Report

09/24/2013 10:11am ET | Updated December 6, 2017
FILE - In this June 30, 2009 file photo, Tylenol Extra Strenth is shown in a medicine cabinet at a home in Palo Alto, Calif. Johnson & Johnson is expanding a recall of over-the-counter drugs Thursday, July 8, 2010, including Tylenol and Motrin IB because of a musty or moldy smell. (AP Photo/Paul Sakuma, file)

Not only is acetaminophen, the active ingredient in Tylenol, the deadliest over-the-counter pain reliever on the U.S. market, but its dangers are being overlooked by members of the public and health officials, according to a new joint report by ProPublica and public radio program "This American Life."

Released this past week, the comprehensive exposé on Tylenol and other products containing acetaminophen highlights the numerous tragedies that this ignorance has caused. The problem, said "This American Life" host Ira Glass, is that although most people seem to know that taking Tylenol and other medications containing acetaminophen can be potentially damaging to the liver, especially when taken in combination with alcohol, few know that a "relatively small overdose can kill you."

Between 2001 and 2010, more than 1,500 people in the U.S. died from accidental acetaminophen overdoses, ProPublica reports. This number, said the news outlet, citing data from the U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers, is far higher than any other over-the-counter pain reliever.

Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually and results in 33,000 hospitalizations a year, federal data shows. Acetaminophen is also the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health.

Most experts and health officials agree that when taken as recommended, Tylenol and other medications containing acetaminophen are relatively risk-free. However, as the new report points out, taking twice or sometimes even just a little bit more than the daily recommended dose of 4 grams of Tylenol over the course of a few days can result in severe illness and even death.

Quoting a report by the U.S. Food and Drug Administration, "This American Life" reporter Sean Cole says that taking even 5 grams a day of Tylenol could hurt your liver. In other words, the difference between a safe dose and a dangerous one could be just two tablets of Extra Strength Tylenol.

In contrast, one would need to take several times the recommended dose of other popular over-the-counter painkillers -- 20 times the recommended dose of Ibuprofen (Advil, Motrin) and about 6 to 8 times that of Aspirin -- to cause toxicity, according to Cole.

Listen to the full "This American Life" report here:

According to the joint report, an expert panel convened by the FDA in 1977 told the agency that it was "obligatory" for it to put a "severe liver damage" warning on the drug. As the Associated Press noted in an August report, it took a whopping 32 years for the FDA to finally add the warning; and even then, ProPublica says, the agency still didn't implement other safety rules regarding acetaminophen that had been endorsed by its own advisory committees.

"They are very slow to respond to these things and it's always a little frustrating," Dr. Lewis Nelson of New York University, who chaired the 2009 FDA panel that voted to add the warning label to the drug, told the AP.

In addition, ProPublica writes that "four years ago, another FDA panel backed a sweeping new set of proposals to bolster the safety of over-the-counter acetaminophen." The agency, however, still hasn’t implemented them.

McNeil, the company behind Tylenol, the leader in acetaminophen sales in the U.S., has allegedly been similarly sluggish in its response to the high number of accidental overdoses in the country. Though the company has taken some steps to protect its customers, it hasn't been enough, ProPublica says.

On the upside, the company has funded the development of an antidote to acetaminophen poisoning. Earlier this year, it announced that it will soon add red lettering to the bottle caps of Extra Strength Tylenol. The warnings will say "Contains acetaminophen" and "Always read the label."

ProPublica also alleges that McNeil has "repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug."

McNeil has disputed parts of ProPublica's exposé and has accused the nonprofit of biased reporting. A company representative told The Huffington Post that McNeil is dedicated to preventing accidental overdoses on acetaminophen and stressed that Tylenol is safe to consume when taken at the recommended dose.

Ed Kuffner, vice president of medical affairs and clinical research at McNeil, told the HuffPost that "it's important for people to know that every medicine has risks" and that if "people don't take the recommended dose," that risk increases.

Millions of people take Tylenol weekly without incident, and experts say that the health benefits of the drug, when taken at the recommended dose, continue to outweigh the risks. But the question remains: Should more be done to prevent accidental overdoses of Tylenol and other acetaminophen-containing products, especially when these deaths and hospitalizations may be preventable?

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