Tylenol’s Risks Not Fully Understood

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 u2013 known in many coun­tries as parac­eta­mol u2013 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.

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 u2013 54 per­cent u2013 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 u2013 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 u2013 McNeil Con­sumer Health­care, a divi­sion of John­son & John­son u2013 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, u2018Read 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.


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