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Tylenol’s Risks Not Fully Understood, Poll Shows

Most Americans know that overdosing can be dangerous but many wrongly think it’s safe to mix drugs containing acetaminophen, a nationwide poll found.

(Lars Klove for ProPublica)

Americans have a spotty understanding of the risks of Tylenol, a nationwide poll conducted earlier this year shows.

About half said they are not aware of any safety warnings involving the drug. But 80 percent said that overdosing on the medicine could result in serious side effects.

Thirty-five percent of those surveyed said it was safe to mix Tylenol with another medicine that contains acetaminophen, the active ingredient in Tylenol. This practice is known as “double dipping” and can lead to accidental overdoses.

Taken together, the results suggest a mixed record of success for the labels on Tylenol packages intended to warn consumers about the dangers of the drug. It also suggests that the acetaminophen public awareness campaigns sponsored over the past several years by the U.S. Food and Drug Administration, the drug industry and McNeil Consumer Healthcare Products, the Johnson & Johnson unit that makes Tylenol have yet to be fully effective.

When taken as recommended, acetaminophen – known in many countries as paracetamol – is generally safe, with few side effects. But at higher amounts, it can damage the liver, sometimes with lethal consequences.

As an investigation by ProPublica reported last week, about 150 people die each year after accidentally ingesting too much acetaminophen, according to data from the Centers for Disease Control and Prevention. Tens of thousands more are sent to hospitals and emergency rooms for treatment from acetaminophen poisoning, studies show. The FDA now calls acetaminophen toxicity a “persistent, important public health problem.”

The telephone poll of 1,003 adults was conducted by Princeton Survey Research Associates International in February and March, and it has a margin of error of 3.5 percentage points. It was commissioned by ProPublica and This American Life, which produced a radio story on the risks of acetaminophen. Full results from the survey are here.

Are you aware of any safety warnings regarding Tylenol?

 

Source: Princeton Survey Research Associates International (See result.)

Are there any safety warnings about consuming alcoholic drinks when using Tylenol?

 

Source: Princeton Survey Research Associates International (See result.)

Is it safe to take Nyquil along with the maximum recommended dose of Extra Strength Tylenol?

 

Source: Princeton Survey Research Associates International (See result.)

Fifty-one percent of poll respondents were unaware of any safety warnings associated with Tylenol. However, 68 percent correctly said that liver damage could result from taking too much of the drug, while 55 percent said that an overdose could lead to death.

To gauge whether these responses reflected a real knowledge of the dangers of overdosing, the poll also asked about problems that are not caused by excessive consumption, including heart palpitations, tingling in the fingers and severe brain damage. But large numbers gave the wrong answer. For example, almost half of those surveyed (49 percent) said incorrectly that overdosing could cause heart palpitations, calling into question how much Americans truly understand about the risks of overdosing on acetaminophen.

A little more than half of those surveyed – 54 percent – said they had heard of warnings about mixing Tylenol and alcohol. Studies have shown that alcohol can make the liver more susceptible to damage from the drug. The FDA warns consumers on product labels against taking acetaminophen after three drinks.

Sizeable numbers of Americans also said they believed it was safe to take several different medications containing acetaminophen at once, the poll found.

For instance, 35 percent of respondents said it was safe to combine the maximum recommended dose of Extra Strength Tylenol with NyQuil, a cold remedy that also contains acetaminophen. It is not, according to the FDA.

People who take multiple acetaminophen products may inadvertently exceed the FDA’s maximum recommended daily dose of 4 grams, or eight extra strength acetaminophen pills. The FDA has cited reports of people suffering liver injury after taking between 5 and 7.5 grams per day over several days. ProPublica has created a simple app that allows people to look up how much acetaminophen is in many common drugs.

Regulators worry that people don’t understand that many medicines contain acetaminophen – more than 600 in all, including commonly used prescription drugs such as Vicodin and Percocet.

Michael S. Wolf, a professor at Northwestern University’s medical school, has studied double dipping and says the practice is “a reflection of how horrible our health system is at communicating the active ingredients” in medications.

The FDA has required over-the-counter acetaminophen to carry a warning that the drug can cause “severe liver damage” since 2009. While it mandates that prescription medications containing acetaminophen warn that overdosing can lead to “death,” no such warning is required for over-the-counter acetaminophen. About 60 percent of the drug is sold without a prescription.

The FDA’s Safe Use Initiative provides advice on how to correctly use acetaminophen through pamphlets, a webpage and YouTube videos, the most popular of which has been seen some 19,000 times since it debuted in January 2011.

“Public education and public campaigns are not something that the FDA is well resourced for,” said Dr. Sandra Kweder, an FDA official who helps regulate the drug and appears in the video.

The maker of Tylenol – McNeil Consumer Healthcare, a division of Johnson & Johnson – sponsors its own informational website, Get Relief Responsibly. The company also has created television advertisements, posters for doctors’ offices and a YouTube channel to educate consumers.

“McNeil has been a leader in educating doctors and providing materials about overdose and misuse of medicines containing acetaminophen,” the company said in a statement. It said its “acetaminophen awareness messages have been seen over one billion times.”

The Consumer Healthcare Products Association, an industry group representing McNeil and other acetaminophen makers, has worked in consultation with the government to create the Know Your Dose education campaign.

“We want to be as constructive and helpful as we can, to say, ‘Read and follow the label, taking too much can lead to liver damage, and don’t take two products at the same time,’” said Emily Skor, vice president of communications for the organization.

About 26 BILLION doses of acetaminophen are sold every year in the US.  150 deaths per year from people taking huge doses is statistically vanishingly small.  There are many other public health problems that cry out for more attention.

From NCBI (National Center for Biotechnology Information), a division of NIH:
Analysis of national databases show that acetaminophen-associated overdoses account for about 56,000 emergency room visits and 26,000 hospitalizations yearly. Analysis of national mortality files shows 458 deaths occur each year from acetaminophen-associated overdoses; 100 of these are unintentional. The poison surveillance database showed near-doubling in the number of fatalities associated with acetaminophen from 98 in 1997 to 173 in 2001. AERS data describe a number of possible causes for unintentional acetaminophen-associated overdoses.

Anita Mitchell

Sep. 24, 2013, 8:59 a.m.

“Vanishingly small” does not take into account all the years acetamenophen was NOT labeled (black boxed) warning of the synergy with alcohol.  And then, years ago when I worked on the psychiatric ward (adolescent psych) the staff used to pass out 4-6 500 mg. at a time!  They actually would do this more than once a day because the PDR (Physicians Desk Reference) monograph stated that was safe.  I know this because I questioned the staff about so many 500 mg. tablets at one time and they told me to go look it up! 

And then…..how about in the 70s and 80s when it was not yet black boxed warning of synergy with alcohol and every teen and young adult who had too much to drink took a couple of 500 mg. tablets thinking it would prevent tomorrow’s hang-over headache.  How much liver failure is impossible to gauge when you don’t parse out the liver failures that were never connected to insufficient or incorrect warnings?

Recently (1-2 years ago) approved for use in neonates for pain relief. What a bad idea that was.  NPR did an hour on this topic (This American Life) and although I knew most, it was still an earful.  I never buy tylenol, but that the advertisements can state “Doctors recommend most as safest.” is an indictment of the horribly incestuous relationship between pharma and doctors. Reminds me of HRT fiasco (hormone replacement therapy) for women.  Very sad.

I can’t take NSAIDS anymore because of Chronic Kidney Disease so my doctor told me to take Tylenol for pain relief.  If it causes liver damage and maybe we shouldn’t take it, either, then what pain reliever can one take?

Given these results, I’d be curious about one other statistic:  What percentage of the people who are aware of the warnings put any stock in them?

I ask because we do live in a world where trust of large organizations is a bit low.  It’s easy to see why, I guess.  We have politicians sure that the solution to a disease (obesity, say) is just to attack a tiny element (large-sized drinks) of a much larger puzzle (cheap, pervasive sugar substitutes).  We have philosophical objections to vaccination that may well stem from the fact that the manufacturers seem to do a lot of shady things, like the HIV-contaminated vaccines that were…shipped to Europe for sale.  We also have groups along the lines of marijuana legalization advocates, who seem to think the entire industry and governance is a scam.

So, even if everybody could recite the warnings by memory, I wonder how good they’d do, especially for something we all grew up with as “harmless.”  It’d be like having a warning on soap to check with your doctor before use…

Gayle, I’m no doctor, but I see it as a matter of weighing the risks.  If it was me, I’d buy a pharmacist lunch to pick her brain over what’s the best bet, because the risk of liver damage may well be worth it, in some cases.  Or maybe it’ll be the risk of an ulcer from aspirin or something else entirely.  If you’re not chugging the bottle, it may not make much difference what you take.

But anything is going to carry a risk of some sort.  You just want to be aware of what the risks are and make the closest choice for your own future.

John…..a wise suggestion that you have here…..I will talk to my pharmacist…thanks for your comment.

Sorry to break it to you but if you are taking any kind of medicine it is going to be damaging to an organ. Which organ depends on where the drug is metabolized in your body—- tylenol (acetaminophin/apap) is metabolized by the liver- NSAIDS (ibuprofen/naproxyn ect) are metabolized in the kidneys. You have to decide which is the lesser evil. If you have liver problems you probably will have to take nsaids if you have kidney issues obviously you need to take tylenol. However do know that taken irregularly and within reasonable doses either are safe. The drug has to be broken down somewhere or it will not do you any good! You are alloted more tylenol in a day than you are nsaids though. You cannot exceed 2400 mg of ibuprofen safely in a day.. and you cannot exceed 550 mg of naproxen daily.. where as tylenol is about 8000 mg/ day.. I feel like they have lowered that recently but I cannot remember the new recommended daily dose that is safe.

I ended up in the hospital for five days in 2010 for “accidental Tylenol overdose.” I started taking the Tylenol to lessen a fever I was experiencing due to a bladder infection. Because the fever never really went away unless I took Tylenol, I continued to take it for about four days, never more than 8 to 10 pills a day, which I realize is more than the directed dose, but not by a lot. By the fourth day, my fever rose to 105 degrees, which is when my friend took me to the hospital. After five days of intensive Tylenol “detox” (which consisted of the most horrible medicine I’ve ever had the pleasure of tasting every few hours), I was finally okay enough to be discharged. The worst part of the experience was the condescending way many of the healthcare professionals spoke to me, because they assumed I had purposely taken large doses of the Tylenol. They would talk to me like I had tried to kill myself. NOT TRUE. I kept insisting that wasn’t the case, and they would shrug it off.

I don’t want to discount a single one of the deaths, near-deaths, or illnesses that resulted from acetaminophen use, but I’m perplexed by this series. I’m glad someone clarified the # of ER visits re: acetaminophen - and the numbers are surprising - but without having any comparison data to other OTC pain relievers, I don’t know what to do with the information.

The series feels, I don’t know, *pushed* somehow. What prompted the series? Why now? What am I not getting?