[ F R O M P U B L I C AT I O N T O P R A C T I C E ]
An interdisciplinary look at labeling changes for
ACETAMINOPHEN AND THE
IMPLICATIONS FOR PATIENT CARE
[ FACULTY ]
Joseph W. Shega, MD,
Chairperson
Associate Professor of
Medicine ❙ Department
of Medicine, Section of
Geriatrics ❙ University of
Chicago Medical Center ❙
Chicago, IL
Mary Beth Morrissey,
PhD, MPH, JD
Postdoctoral Research
Associate ❙ Fordham University
Graduate School of Social
Service ❙ New York, NY
Manney Carrington Reid,
MD, PhD
Director ❙ Cornell Roybal
Center, Division of Geriatrics
and Gerontology ❙ Weill Cornell
Medical College ❙ Cornell
University ❙ New York, NY
Developed by
The Gerontological Society of America
Supported by McNeil Consumer Healthcare
[ LEARNING OBJECTIVES ]
After reading this publication, the provider will be able to:
[ ] D
 escribe labeling changes for acetaminophen and the safety concerns that led to
the changes.
[ ] D
 iscuss specific issues surrounding the labeling changes that impact patient care
for older adults.
[ ] Recommend dosage adjustments for older patients taking acetaminophen.
[ ] E
 ffectively communicate with older adults about the critical need to follow new
acetaminophen dosage recommendations and directions for use.
[ ] D
 iscuss pain management guidelines for older patients in pain, including alternative
medications and therapies.
[ ] Identify resources and new initiatives supporting safe use of acetaminophen.
Introduction
Acetaminophen is present in more than 600 over-the-counter (OTC) and prescription
products used by more than 50 million Americans each week. This commonly used
medication is taken to treat conditions such as pain, fever, and the aches and pains
associated with cold and flu. In fact, acetaminophen—OTC or prescription—is the most
frequently prescribed agent for pain relief.
Notably, acetaminophen is also the leading cause of acute liver failure in the United States.
According to the U.S. Food and Drug Administration (FDA), acetaminophen-related damage
to liver cells was the leading cause of acute liver failure (42%) during the period from 1998
to 2003. Unintentional overdose of acetaminophen accounted for 48% of these cases. An
estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to
acetaminophen overdoses occurred each year from 1990 to 1998.1
These surveillance data and other reports in the medical literature have raised concern
about the safety of acetaminophen and have spurred the FDA to make changes to the
dosage and labeling of acetaminophen products in the United States over the last several
years. The goal of these modifications is to make patients aware of the presence and
amount of acetaminophen in single-ingredient and combination products with the goal of
preventing the accidental overdoses thought to be responsible for much of the liver damage.
It should be emphasized that the maximum daily dosage—3,000 mg for self-treating users
and 4,000 mg for those under a physician’s care—is safe.
Specialists in pain and palliative medicine as well as generalists need to receive ongoing
training in principles of pain assessment and pain management. They also must spend time
educating the older adults they serve about the complexities of pain. An interdisciplinary
approach is required to educate all patients who are prescribed opioid-acetaminophen
combination products about the inclusion of acetaminophen in the formulation, the widespread
[ ©2011 The Gerontological Society of America. All rights reserved. Printed in the U.S.A. ]
[ PRE-ACTIVITY QUESTIONS ] inclusion of acetaminophen in other
OTC products, and the maximum
Assess your baseline knowledge by answering the following questions: recommended daily dosage. This
monograph presents concise
[ 1 ] The FDA has facilitated the following changes to OTC information regarding the changes to
acetaminophen labeling, except: acetaminophen labeling in order to
a] A
 warning about the potential for liver toxicity. facilitate patient education.
b] A
 warning to consumers not to take more than the recommended
daily dosage.
Changes to Acetaminophen
c] A
 dvice for patients not to take acetaminophen with other drugs
Labeling
containing acetaminophen.
OTC: In past years, the FDA has
d] A
 dvice for patients to contact their physician before consuming
advocated for changes to the labeling
acetaminophen if they are taking any prescription medication.
and packaging of OTC acetaminophen
to better inform consumers about
[ 2 ] Which of the following statements about physician knowledge
the risk of hepatotoxicity.2 Previous
of acetaminophen dosing is correct?
changes included:
a] P
 hysicians are not aware of prescription medications that
■■ Prominent display of the ingredient
contain acetaminophen.
acetaminophen on the container and
b] P
 hysicians often are not aware of OTC medications that
outer carton.
contain acetaminophen.
■■ Warnings on the product label about
c] P
 hysicians usually recognize which OTC therapies contain
the potential for liver toxicity.
acetaminophen. ■■ Warnings to consumers against
d] T
 he majority of physicians know the maximum dose of using more than the recommended
acetaminophen recommended in a 24-hour period. daily dosage.
■■ Advice for patients not to use
[ 3 ] With regard to acetaminophen and acute liver failure, acetaminophen in conjunction
acetaminophen-related overdoses:
with any other drug containing
a] A
 re the most common cause of acute liver failure in the United States. acetaminophen (OTC and/or
b] A
 re most often intentional. prescription).
c ] Occur when acetaminophen was reportedly taken for high fevers. ■■ Instructions to people with a history

d ] Are rarely associated with opioid-containing products. of heavy alcohol use and those who
consume three or more alcoholic
[ 4 ] The following approach to pain management in older adults is drinks per day to consult a physician
not an accepted part of the standard of care: before taking analgesic/antipyretic
a] M
 ultidisciplinary collaboration among professionals. products including acetaminophen.
b] M
 ultimodal therapy. ■■ Directions to ask a physician or

c ] Comprehensive assessment of pain. pharmacist about acetaminophen

d ] Inattentiveness to the patient’s verbal and bodily expressions of pain. use if the consumer has liver disease
or is taking the blood thinner
[ 5 ] Factors that have been identified to decrease analgesic medication warfarin.
adherence in older adults include: These packaging changes were
a] F
 ear of negative side effects. implemented to help consumers
b] C
 oncerns about addiction. decrease inadvertent exposure to
acetaminophen by unknowingly taking
c ] Fear of tolerance necessitating increased doses of a pain medication.
more than the recommended dosages
d ] All of the above.
as well as highlighting individuals at
higher risk of acetaminophen-related
[1]d [2]b [3]a [4]d [5]d ANSW ER KEY: adverse effects.

2 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
 THE RISK OF LIVER INJURY primarily occurs when patients take multiple products containing
acetaminophen at one time and exceed the maximum dosage of 4,000 mg within a 24-hour period.

Prescription: More recently, the allergic reactions also will be added to [ MYTH 1 ]
FDA announced that it is asking prescription acetaminophen products.1,3
manufacturers of prescription Manufacturers also are taking Acetaminophen is a tried and true,
acetaminophen combination products steps to decrease the likelihood of safe medication.
to limit the maximum amount of consumers inadvertently taking too
FACT: Acetaminophen is
acetaminophen in these products to much acetaminophen and developing
safe when used as directed.
325 mg per dosage unit. Currently, hepatotoxicity. For example, McNeil
However, accidental overdoses
combination prescription products Consumer Healthcare recently
of acetaminophen are associated
contain acetaminophen doses ranging announced changes to its OTC single-
with acute liver failure in the United
from 300 mg to 750 mg per tablet. The ingredient Extra Strength Tylenol®,
States. Self-treating users should
FDA believes that a 325 mg limit will along with its liquid formulation.4 As of
read the label carefully and take
reduce the risk of severe liver injury from November 2011, the labeling for the
only the recommended maximum
inadvertent acetaminophen overdosing. 500 mg package of this OTC product
daily dosage of 3,000 mg. Patients
In addition, the FDA will require that the contains new directions for use that
may take a higher daily dosage—
labeling of prescription products contain reduce the maximum daily dosage to
up to 4,000 mg—if their physician
a “black box” warning (the Agency’s 3,000 mg unless a doctor recommends
instructs them to do so. On the
most serious type of warning for a 4,000 mg daily limit. Transition to the
other hand, the maximum daily
prescription drugs) calling attention to new labeling will take several months.
dosage may be decreased for
the life-threatening risks associated with Labeling for the 325 mg OTC product
patients who consume alcohol.
the consumption of acetaminophen, will be changed to reduce the maximum
including liver failure, liver transplant, and daily dosage to 3,250 mg. The existing
death. A general warning about potential warning that severe liver damage may
occur if more than 4,000 mg per day
are taken will not change. The plans of
other manufacturers of acetaminophen
products are not known at this time.
FDA-REQUIRED “BLACK BOX”
WARNING ON PRESCRIPTION
Safety Issues
ACETAMINOPHEN
The FDA’s position is that acetamino-
MEDICATIONS 3,4
phen overdoses result in a large and
“[This product] contains unacceptable number of cases of
acetaminophen... liver failure in the United States; even
Acetaminophen has been
associated with cases of acute LABELING CHANGES TO DOSING OF EXTRA STRENGTH
liver failure, at times resulting TYLENOL® 500 MG CAPLETS
in liver transplant and death.
Old Directions
Current Directions
Current Directions Revised Directions
Revised Directions
Revised Directions
Most of the cases of liver injury
are associated with the use of Directions Directions Directions Directions
do not take more
do not
than
take
directed
more than
(see directed
overdose(see
warning)
overdose warning) do not take more
do not
than
take
directed
more than
(see directed
overdose(see
warning)
overdose warning)
acetaminophen at doses that adults and adults take
and 2 caplets take
every2 4caplets
to 6 hours
everyas4needed
to 6 hours as needed adults and adults take
and 2 caplets take
every2 6caplets
hours while
every 6symptoms
hours while
lastsymptoms last
exceed 4,000 mg per day, children 12 children do12
years and overyears and
not take moredo not
overuse for do
thantake
8 caplets
more than
in 248hours
caplets in 24 hours children 12 children do12
years and overyears and
not take moredo not
thantake
overdirectedunless
unless
6 caplets
by a doctor
more than
in 246hours,
caplets in 24 hours,
directed by a doctor
do not more
notthan
use for
10 days
moreunless
than 10 days unless
often in combination with other directed by a doctor
directed by a doctor do not use for do
more
notthan
by a doctor by a doctor
use for
10 days
moreunless
than 10directed
days unless directed

acetaminophen-containing children underchildren

12 years
do not
12 years
under
use thisdoExtra
not use
under 12 yearsunder
Strength
of age;
this Extra
12 this
yearswill
product
Strength
ofprovide
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will provide more children underchildren
ask aunder
doctor ask a doctor
12 years 12 years
products.” than the recommended
than the recommended
TYLENOL® andTYLENOL®
dose (overdose)
may causeand liver
maydamage
doseof (overdose) of
cause liver damage

The Gerontological Society of America 3

 COMMON BRANDS OF MEDICATIONS small amounts over the recommended and hospital admissions related to
CONTAINING ACETAMINOPHEN6 daily dosage can cause serious liver unintentional overdoses.2 The majority
OTC Products Prescription Products damage.2 Moreover, liver injury has oc- of these overdoses were reported
Actifed Plus
®
Endocet® curred in some patients taking the rec- to be inadvertent.9 Of patients who
Alka-Seltzer Plus® Esgic-Plus® ommended doses, possibly occurring inadvertently overdosed and developed
Anacin® Fioricet® secondary to genetic predisposition acute liver failure, 81% reported taking
Contac ®
Hydrocet® and/or concomitant alcohol consump- acetaminophen for acute and/or
DayQuil ®
Lortab®
tion.2,5 Certain individuals—such as chronic pain, 38% were simultaneously
Excedrin ®
Norco®
those with pre-existing liver disease, taking two or more acetaminophen
Feverall ®
Oxycet®
those who drink more than three alco- preparations, and 63% used opioid-
Goody’s® Powders Percocet®
holic beverages per day, or those who containing compounds.9
NyQuil ®
Phenaphen®
Robitussin ®
Phrenilin® take more than one acetaminophen- Studies suggest that consumers and
Sudafed ®
Roxicet® containing medication—are at higher medical professionals lack adequate
Theraflu ®
Roxilox® risk of liver toxicity even in the range knowledge surrounding acetaminophen
Triaminic® Tramadol® considered safe and therapeutic (i.e., products and their potential toxicity.
Tylenol® Tylenol® with codeine up to 4,000 mg daily). A survey of patients in a clinic setting
Vanquish ®
Tylox® Another impetus for the taking an acetaminophen product
Vicks Formula 44
® ®
Vicodin® recommended changes by the FDA found that only 26% reported
And store brands Zydone®
are reports that individuals may knowledge of the active ingredient.10
And generic drugs
unknowingly be taking more than Of the 84% who were aware that toxic
one acetaminophen-containing amounts of acetaminophen ingestion
product concurrently. More than 600 were possible, only 33% knew the
acetaminophen OTC single-ingredient recommended maximum daily dosage.
and combination products and Another study that examined patient
prescription therapies are available to knowledge about acetaminophen

CONSUMERS AND MEDICAL PROFESSIONALS lack

adequate knowledge about acetaminophen products and their
potential toxicity.

consumers (see table for partial list).
These products are used for analgesia,
fever, colds and cough, flu symptoms,
allergies, and sleep aids.
According to the American
Association for the Study of Liver
Diseases, acetaminophen-related
overdoses are the most common
cause of acute liver failure in the United
States.7 The Adult Acute Liver Failure
Study Group found that 605 of 1,321
cases of acute liver failure at 23 sites in
the United States were acetaminophen-
induced, with an increase from 28% of
the cases in 1998 to 51% in 2003 and
2004.8 These figures do not include
the number of emergency room visits
found that only 50% identified Tylenol®
PM as containing acetaminophen
and less than 15% were aware that
prescription analgesics such as
Vicodin®, Percocet®, and Lorcet®
contained acetaminophen.11
A survey of physicians found
that 24% of respondents were not
aware of the maximum daily dosage
of acetaminophen.12 While most
identified prescriptions that contained
acetaminophen, few could differentiate
OTC preparations that did and did
not contain acetaminophen. Such low
awareness may well have been a factor
in the findings that 5.9% of California’s
Medicaid fee-for-service population

4 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
were potentially exposed to excessive
doses of acetaminophen for at least
1 day between 2004 and 2005.13
As noted above, a majority of patients
who inadvertently overdose and develop
acute liver failure suffer from pain-related
conditions and were taking an opioid-
acetaminophen prescription product.9
Analysis of data from the FDA Adverse
Event Reporting System in 2005
revealed that 59% of acetaminophen-
related fatalities involved the use of
these combination products.2 One
possible contributor to this problem is
the way the prescriptions were written.
For example, a prescriber may write
the instructions for a hydrocodone-
acetaminophen formulation with 750 mg
of acetaminophen to “take 1-2 tablets
every 4-6 hours for pain.” If 2 tablets are
taken every 4 hours, the patient would
ingest 9,000 mg of acetaminophen in
24 hours. Moreover, without further
instruction from the health care provider,
the patient may consume additional [ MYTH 2 ]
acetaminophen-containing OTC
preparations, such as those targeted for Patients may take 2 tablets of
pain or sleep.14 Extra Strength Tylenol® every
4 to 6 hours.
Liver Damage
FACT: The directions for use
Excessive acetaminophen overloads
have changed. Previously,
the liver’s ability to process the drug
patients were advised to take 2 of
safely. As a result, toxic chemical by-
the 500 mg caplets every 4 to 6
products of acetaminophen metabo-
hours. Now patients are advised
lism build up beyond the levels that the
to take 2 of the 500 mg caplets
body can easily eliminate, causing
every 6 hours and not to take
serious damage to the liver. Liver
more than 6 caplets in 24 hours,
damage can develop into liver failure
unless directed by a doctor.
or death over several days.
The signs and symptoms of liver
damage may not be evident right
away. Early symptoms such as loss of
appetite, nausea, and vomiting may
be mistaken for symptoms of the flu.
Later symptoms include the former plus
yellow skin and eyes, dark urine, and
light-colored stools. Serious cases may
cause mental confusion.14
The Gerontological Society of America 5
[ FAST FACTS ABOUT OLDER ADULTS AND MEDICATION USE 26,27 ]
■■ While 13% of the U.S. population
are older adults, they account for
34% of all prescription drug use
and 30% of OTC drug use.
■■ Prescription drug use increases
with age: 88.4% of adults 60 years
of age and older take at least one
prescription drug; 36.7% take five
or more prescription drugs.
■■ Most older adults—approximately
80%—have one or more chronic
conditions.
6 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
■■ Older adults are at increased
risk of serious adverse effects
from drug use.
■■ Drug interactions are especially
common in older adults due
to polypharmacy.
■■ Almost 40% of older adults cannot
read prescription labels.
■■ Two-thirds of older people
are unable to understand the
information given to them about
their prescription medications.
Pain Management in
Older Adults
The complex health care needs of
older adults call for interdisciplinary
approaches to optimize their health and
INADEQUATE PAIN MANAGEMENT for vulnerable older adults
has been widely recognized as a public health problem.
well-being.15,16 The right to health and
well-being is a well-established hu-
man right and health care justice issue
that requires appropriate public policy
responses including attention to pain
management.17 The primary goals of
effective pain management for older
adults living with pain and serious or
life-threatening illness are to:
■■ Protect their dignity.
■■ Maintain or improve function.
■■ Optimize quality of life.
■■ Reduce pain levels and illness
burden.
■■ Prevent or relieve suffering.
Untreated and undertreated pain
as well as ineffective communication
practices about patients’ pain care
needs have been documented in the
literature.18–24 In light of these and
other findings, pain management is
now recognized as one of the major
and essential pillars of a palliative care
approach to person-centered and
geriatric care.25 Both the American
Geriatrics Society (AGS) and the
Institute of Medicine (IOM) have been
instrumental in bringing national
attention to this critical issue affecting
the public health.
AGS Pain Guidelines
In 2009, AGS updated its clinical
practice guidelines that address the
factors affecting pain in older persons,
describe pharmacological and non-
pharmacological strategies to pain
management, and discuss the risks
and benefits of such strategies based
on research evidence as well as clini-
cal experience and consensus. The
guidelines, which were developed by
a panel of experts and peer-reviewed,
provide well-supported recommenda-
tions to primary care clinicians and
other health professionals, research-
ers, and policy makers.28
Challenges identified in the
assessment, evaluation, and treatment
of pain in older adults are multiple: they
include the complex and inconsistent
manifestations of pain in older adults,
the physiological aging process,
underreporting of pain, the prevalence of
comorbidities, higher rates of treatment
complications including the incidence of
adverse reactions to medications, and
a lack of empirical data on interventions
and clinical outcomes (such as dose
adjustment) for this group.28,29 AGS had
earlier reported patterns of systematic
exclusion of older adults from clinical
trials.30 In addition, the IOM documents
that national population-based health
surveys typically do not target individuals
residing in nursing homes or in chronic
care or corrections facilities.20 However,
there is broad consensus that in the
absence of empirical evidence, clinical
experience may be relied upon when
appropriate in making decisions and
determining best practices for pain
management.16
There is substantial evidence in
the literature of high prevalence rates
of pain and disparities in pain care
among older adults in various settings,
THE AGS GUIDELINES recommend acetaminophen as first-line
therapy for pain and as ongoing therapy for persistent pain.
including nursing homes, emergency
departments, and prisons as well as
community-dwelling individuals.19,21,24,30-36
Consequences of untreated and
undertreated pain for older adults range
from depression and anxiety to reduced
function and relational intimacy as well
as compromised quality of life.37 Such
findings have heightened concern for
the oldest, sickest, frailest, and most
vulnerable subgroups of the older adult
population.30
The AGS guidelines include
detailed recommendations for the
use of acetaminophen in the older
adult population. Relying on the
cited, demonstrated evidence of
safety and effectiveness compared
with traditional non-steroidal anti-
inflammatory drugs (NSAIDs), the
guidelines recommend acetaminophen
as first-line therapy for pain and as
ongoing therapy for persistent pain.28
However, persistent pain in older adults
often requires multimodal treatment
including opioid analgesics as well as [ MYTH 3 ]
physical, psychological, and social
interventions.16,28 Acetaminophen is contained
In addition to pharmacological only in single-ingredient
management, many self-help pain medications.
alternatives or complementary
FACT: Other OTC remedies such
therapies are available to older adults
as those for headache, colds
with pain including physical therapy,
and flu, arthritis, and toothaches
cognitive behavioral therapy, patient
are often combination products
and family education, community
that contain acetaminophen.
support groups, prayer, massage,
Prescription medications such
biofeedback, hypnosis, guided visual
as opioids for relief of severe or
imagery, and music.28,38
chronic pain also often contain
acetaminophen.
IOM Report on Relieving Pain
in America
The 2011 IOM report Relieving Pain
in America: A Blueprint for Trans-
forming Prevention, Care, Education
and Research provides a timely and
comprehensive response to the grow-
ing public health problem of untreated
and undertreated pain among older
adults and the challenges of pain
management. The report identifies
older adults as an at-risk population
and describes the aging life cycle as
a factor in the development of chronic
pain. Among the IOM recommenda-
tions concerning the care of older
adults are enabling self-management
of pain, eliminating barriers to ade-
quate pain care, and promoting inter-
disciplinary research and training for
those who are conducting research
on pain.20
A comprehensive assessment of pain
is central to effective pain management
in any population; it is critically
important for older adults who typically
have declining health trajectories often
compounded by frailty, chronic illness,
The Gerontological Society of America 7
[ MYTH 4 ]
Healthcare providers routinely
caution their patients about the
risks of acetaminophen.
FACT: Research has shown that
many health care providers are not
aware of which products contain
acetaminophen and do not know
the safe maximum daily dosage
of acetaminophen. The FDA and
other organizations are urging
health care providers to more fully
educate their patients about the
risks of this common ingredient.
8 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
social vulnerability, and diminishing
capacity including dementia.20 HOW IS PAIN DEFINED? 20
The IOM cites barriers to accessing One of the challenges in pain
improved pain care at system, clinician, management education for
and patient levels in the United States. professionals is properly defining
While many of these barriers will the term pain. The IOM report
continue to be encountered in the cites the well-recognized
short term, the delivery of effective pain definition of pain from the
management to older adults begins International Association for the
with a careful history to ensure that Study of Pain:
the provider understands patients’
Pain is an unpleasant sensory
descriptions of their pain experiences.
and emotional experience
Attention to bodily and nonverbal forms
associated with actual or
of expression and communication are
potential tissue damage
particularly important in evaluation of
or described in terms of
older adults who are cognitively impaired.
such damage . . . . Pain is
The IOM report affirms the value of the
always subjective . . . always
pain care model, which encompasses
unpleasant, and therefore an
multimodal assessment in biological,
emotional experience.
psychological, emotional, social, and
cultural contexts. The limitations of pain As the authors of the IOM
intensity measurements and indices of report suggest, this definition
functioning as sole measures of pain also has helped to deepen
are described. understanding of pain as a
Two domains that the IOM report complex and multidimensional
discusses at length are the role of the experience having not only
emotions in understanding pain and physical but also cognitive,
the influence of culture. The affective emotional, social, spiritual, and
dimensions of the pain experience have cultural meanings.
been shown to involve the process of
valuing (i.e., emotional responses to pain
experiences and the values attached to mendations for improvements in pain
them that can influence the trajectory care are aimed at meeting the urgent and
of the pain experience). Values—and often neglected needs of vulnerable older
their expression and communication—in adults. Interdisciplinary collaboration in-
the context of pain also are influenced volving physicians, nurses, psychologists,
by cultural experiences, meanings, and social workers, physical and occupational
attitudes.39,40 Professionals who are therapists, pharmacists, chaplains, and
caring for older adults in pain need to other disciplines is a hallmark of pallia-
demonstrate sensitivity to their patients’ tive care and has been endorsed by the
values and preferences, including Mayday Fund Special Committee on Pain
cultural considerations (e.g., disclosure, and the Practice of Medicine.16 Hospice
truth-telling) and styles of making has provided an example of success-
decisions (e.g., involvement of family ful implementation of the interdisciplin-
members).25 ary team model. It is incumbent upon
physicians, even in primary care settings,
Interdisciplinary Collaboration to maintain dialogues with members of
The call in the IOM report for a “cultural the other professions; to seek support
transformation” and concomitant recom- and counsel when appropriate in the
assessment and treatment of pain; and
to promote health literacy among older
adult patients about prevention and ac-
cess to care.
Impact of Acetaminophen
Changes on Patient Care
The challenge that the FDA faces
involves a balance between ensuring
the availability of pain medications for
patients who need them while also
minimizing the risks these medications
pose. Whether used alone or combined
with another analgesic, acetaminophen
is a common treatment of pain for older
adults. Pain experts have expressed
concern that the new FDA regulations
will result in unintended consequences
including a limit on the use of acetamin-
ophen, a discontinuation of acetamin-
ophen-containing products altogether,
or selection of alternative therapies that
pose a greater potential for toxicity.41
Unintended Consequences
With the new dosage directions for Extra
Strength Tylenol®, self-treating patients
should take the product three instead
of four times per day, which may result
in episodes of insufficient analgesia.42
Diminished pain relief may lead individu-
als to seek additional relief by asking
providers for other therapies including
opioid-acetaminophen combinations. If
prescribed, the patient would be taking
The Gerontological Society of America 9
[ PATIENTS’ KNOWLEDGE OF MEDICATION USE ]
Previous Research About OTC Analgesics: 43
■■ 41% of respondents believed
that OTC drugs are too weak to
cause harm.
■■ Only 34% could identify the active
ingredient in their pain reliever.
■■ 44% took more than the
recommended number of doses
per day (the predominant rationale
given was a belief that taking more
of the medication could increase
its effectiveness).
Recent Research Among Acetaminophen Users: 44
■■ Aware that acetaminophen products are 87% 84%
serious medicines and can cause harm
if misused.
other OTC preparations, namely NSAIDs.
Some marketing campaigns on television
and through other media outlets promote
that consumers can receive as good
■■ 36% reported that they were likely
or better pain control with NSAIDs
to combine OTC medications if
while taking fewer pills and avoiding
multiple symptoms were present
acetaminophen-related liver toxicity.
(e.g., pain and sore throat).
Older adults may be more susceptible
■■ 95% of respondents reported that to the adverse effects of NSAIDs due
they read some portion of an OTC to interactions with other medications
medication label. and changes to the cardiovascular and
■■ 10% read the label for possible renal systems that occur with aging and
side effects. common chronic conditions. In older
adults, NSAIDs are more likely to cause
■■ Lessthan 10% read the label for
stomach or gastrointestinal bleeding
usage warnings.
from long-term use. Other possible
side effects can include stomach pain,
constipation, diarrhea, gas, heartburn,
OTC Users Rx Users
nausea, vomiting, and dizziness.45, 46
Additional serious adverse effects of
NSAIDs are: 47
■■ Heart attack

■■ Stroke
■■ Look for directions regarding dosage. 92% 95%
■■ High blood pressure
■■ Look at the label for warnings 81% 90%
■■ Heart failure from body swelling (fluid
about side effects.
retention)
■■ Ask health care provider about 40% 79% ■■ Kidney problems including kidney
directions for use. failure
■■ Bleeding and ulcers in the stomach

and intestine
IF CONFUSION leads older adults to ingest more acetaminophen ■■ Anemia
than recommended or to switch to riskier medications, the FDA’s ■■ Life-threatening skin reactions
action could potentially increase—not decrease—analgesia-related ■■ Life-threatening allergic reactions
morbidity and mortality. ■■ Liver problems including liver failure

■■ Asthma attacks in people who have

an increased amount of acetaminophen, asthma.

further increasing the risk of hepatotoxic-
ity. Another possibility is that patients will
interpret the changes to indicate that the
500 mg dose is less safe and substitute
the 325 mg formulation. Changing from 2
of the 500 mg caplets (1,000 mg) to 2 of
the 325 mg caplets (650 mg) would likely
diminish analgesic efficacy, decreasing
pain relief and quality of life.
Another possible consequence is that
older adults may become wary about
the use of acetaminophen due to the
packaging changes and instead favor
The FDA has cited the increased
risk for stomach bleeding in people
over 60 years of age who are taking
prescription blood thinners, and/or
have previous stomach ulcers or other
bleeding problems.45, 46 NSAIDs also
can cause reversible damage to the
kidneys. The risk of kidney damage is
higher in people who are 60 years of
age and older, who have high blood
pressure, heart disease, or pre-existing
kidney disease, and those who are
taking a diuretic.47

10 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care

CONSUMING ACETAMINOPHEN in multiple products, such as a
pain reliever and a cold preparation, places people at increased risk
for analgesic-related toxicity.
Challenges to Pain
Management in Older Adults
It remains uncertain whether the labeling
changes will affect the way older adults
take acetaminophen and, if so, in what
way. Research conducted in the early
2000’s regarding older adults’ knowledge
of and practices regarding analgesic
medication use revealed substantial defi-
cits.48,49 Specifically, surveys documented
that many adults lacked basic knowledge
concerning the safety of analgesic medi-
cations, particularly OTC analgesics.43,48,49
However, recent surveys of adults who
had used acetaminophen—OTC and/
or prescription—revealed progress in
awareness of and attitudes about acet-
aminophen (see sidebar on page 10).44
Other research involving older
several salient themes have been
identified. Some older adults endorse
the belief that pain is something “to be
tolerated” or that one should “get used
to the pain” as a means of coping with
pain.49,50 Individuals who endorse this
coping method may not be affected
by the labeling changes because
most of them endorse using analgesic
medications only as a last resort to
treat their pain, placing them at low
risk for experiencing acetaminophen
exposures that could cause harm.
Research also has shown that some
older adults have negative attitudes
about analgesic medication use as a
means of managing pain. Their fears
include: 50–54
■■ Negative side effects such as
[ MYTH 5 ]
Opioids are addictive.
FACT: National guidelines for
managing pain recommend
that opioids may be an effective
strategy for managing pain in older
adults. In fact, opioids present
less risk than traditional NSAIDs.28
Overall, opioid medications
cause fewer serious side effects
than NSAIDs. Addiction to these
medications is rare among older
adults who do not have a history of
drug abuse.55

individuals with symptomatic constipation, nausea, or confusion.

osteoarthritis of the knee found that ■■ Addiction (even to non–habit-forming

54% were unaware of any adverse analgesics).

effects associated with NSAID use.48 ■■ Possible untoward consequences as

These data also suggest that labeling a result of adding another medication
changes may need to be combined to an already long list of medications.
with other interventions to measurably ■■ Development of analgesic tolerance,

alter older adults’ consumption which would require increasing doses

practices regarding OTC analgesics.
The impact of the acetaminophen
labeling changes will likely vary
depending in part on older adults’
pain-related attitudes and beliefs that
affect their willingness to undertake a
trial of an analgesic medication and
adhere to the therapy.50–54 Although
research in this area is preliminary (and
based largely on qualitative studies),
of a pain reliever over time.
Older adults holding negative
beliefs and/or attitudes about
analgesic medications might
respond to the labeling changes by
decreasing or eliminating their use of
acetaminophen altogether. Possible
consequences include switching
to a different analgesic medication
that may cause harm or foregoing

EXPERTS AGREE THAT there is an ongoing need for interventions

directed at raising older adults’ awareness concerning the risks
of acetaminophen and educating them about ways to minimize
acetaminophen-related harm.

The Gerontological Society of America 11

 FDA’S RECOMMENDATIONS EFFECTIVE SELF-MANAGEMENT of pain requires that older
TO HEALTH CARE adults be given information regarding the risks and benefits of all
PROFESSIONALS FOR pain therapies.
PATIENT COUNSELING ABOUT
ACETAMINOPHEN 56
■■ Do
any pain reliever at all, leading to
not take more than
undertreatment of pain.
the prescribed dose of an
Vulnerable populations who may not
acetaminophen-containing
be reached by educational interventions
medication.
include those with functional, cognitive,
■■ Donot take more than or health literacy deficits. Such
one product that contains deficits may occur in older adults with
acetaminophen. significant visual impairments (e.g.,
■■ Read all medication labels— macular degeneration, glaucoma); in
OTC and prescription—to those with limited reading skills due to
ensure that you are not language issues (i.e., English is not the
taking multiple products primary language) or lower educational
that contain acetaminophen attainment; and those with cognitive
simultaneously. impairment in memory, concentration,
■■ Eliminate
or organizational abilities. Prior research
alcoholic beverages
has demonstrated that many older adults
while taking acetaminophen-
lack basic skills to read and process
containing medications.
the health care information necessary
to enable understanding of instructions
on the package label and information
present in patient handouts.57 A study
of Medicare enrollees determined that
being in a minority group (i.e., African
American or Hispanic) and advancing
age significantly increase the likelihood of
low health literacy.58
Communicating With Older Adults
These findings have important impli-
cations for gerontologists and other
health care providers who seek to im-
prove the health and well-being of the
patients they serve. One intervention
that could help to maximize success
of the labeling changes is for provid-
ers to take a careful analgesic medi-
cation history, including the patient’s
use of OTC pain relievers—something
that does not always happen in the
context of a busy medical encounter.
Inquiring about older adults’ attitudes
and beliefs about pain and pain
medication use also could help to
identify opportunities for intervention.
12 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
Health care providers and caregivers
are encouraged to reinforce the mes-
sage that effective self-management
of pain requires that older adults
comprehend information regard-
ing the risks and benefits of all pain
therapies. Finally, assessing patients’
health literacy levels and basic knowl-
edge about analgesic medication use
could help to identify individuals who
may benefit from additional interven-
tions designed to enhance overall
knowledge and awareness of the safe
use of analgesic medications.
Health care providers should view
acetaminophen label and dosage
changes as an opportunity to engage
patients in a discussion about their
pain and its management. Such
discussion should include indentifying
acetaminophen content in OTC and
prescription medications and informing
patients of the risks associated with
taking more than 4,000 mg per
day. Providers also should identify
and educate patients at higher risk
of acetaminophen-related adverse
effects, such as those who consume
three or more alcoholic beverages a
day, have underlying liver disease, or
are on warfarin therapy. Through an
open dialogue, providers can address
questions, clarify misconceptions,
and decrease the likelihood of an
accidental overdose.
Summary
Growing concern regarding the role
of inadvertent overdoses of acetamin­
ophen in liver damage has led to
changes in the manufacture, labeling,
and dosage instructions for this widely
used medication. The maximum dose of
acetaminophen in prescription products mg daily unless instructed to take the
will be limited to 325 mg. Directions for maximum dosage of 4,000 mg per day
use for OTC Extra Strength Tylenol® will by a physician. Warnings about the risk
advise users not to take more than 3,000 of liver damage from prescription opioid

[ E D U C AT IO N AL PROGRAM S ]

Several organizations ranging from federal government agencies to professional medical associations and organizations
dedicated to educating consumers and health care providers in general have created a wide range of rich resources to convey
information about the acetaminophen labeling changes. Some of these programs are:

“Know Your Dose” Campaign on Patient Information and Education. The program,
In January 2010, the Consumer Healthcare Products available at www.mustforseniors.org, offers a variety of
Association and the American Pharmacists Association helpful resources, including a section for consumers on
launched the Acetaminophen Awareness Coalition with the acetaminophen safety and a section for caregivers that
goal of increasing consumer awareness of acetaminophen, provides tips for helping older adults use medications
its safe use, and the potential hazards of overdose. Coali- safely and effectively.
tion members include both professional organizations and
corporate sponsors (manufacturers of pain medications).
“Get Relief Responsibly” Initiative
The FDA and Centers for Disease Control and Prevention
The manufacturer of the Tylenol® brand of acetaminophen,
are special advisors to the coalition.
McNeil Consumer Healthcare, has developed a new
The coalition’s hallmark program is the Know Your Dose
initiative called Get Relief Responsibly. It was designed
campaign, which focuses on providing educational materials
to educate consumers about the appropriate use of
to health care providers. Materials include information cards, a
prescription and OTC medications, particularly those
wall poster, and a 30-second video for the providers’ offices,
containing acetaminophen. Details on the new dosing
pharmacies, and clinics. All are free to providers and may be
recommendations, guides for reading labels, and other
downloaded from the website www.knowyourdose.org.
useful information on acetaminophen and other pain
Know Your Dose core messages to consumers include:
■■ Reading and following label directions are critically
medications may be accessed at www.tylenol.com/
important. getreliefresponsibly.
■■ Know if your medicines contain acetaminophen.

■■ Never take two medicines that contain acetaminophen at

the same time.

■■ When used as directed, medicines containing
acetaminophen are safe and effective.
■■ Taking more acetaminophen than directed—an
overdose—can cause serious liver injury.
“Medication Use Safety Training (MUST)
for Seniors” Program
A comprehensive program directed to older adults and
caregivers is the Medication Use Safety Training (MUST)
for Seniors program created by the National Council
“Safe Use of Acetaminophen” Campaign
The FDA developed a national consumer education
campaign that includes posters, fact sheets, a
brochure (in English and Spanish), and other materials
to help consumers safely choose products containing
acetaminophen and to provide advice on their safe use.
These materials may be accessed on the FDA website:
www.fda.gov/Drugs/ResourcesForYou/Consumers/
BuyingUsingMedicineSafely/UnderstandingOver-the-
CounterMedicines/SafeUseofOver-the-CounterPainReliev
ersandFeverReducers/ucm164977.htm. Hard copies may
be ordered at no cost from dpapubs@fda.hhs.gov.

The Gerontological Society of America 13

[ RESOURCES ]
Acetaminophen Awareness
Coalition
www.knowyourdose.org
Alliance of State Pain Initiatives
www.aspi.org
American Geriatrics Society
www.americangeriatrics.org
American Pain Foundation
www.painfoundation.org
Consumer Healthcare
Products Association
www.chpa-info.org
Food and Drug Administration
Acetaminophen Information
www.fda.gov/acetaminophen
For Consumers
www.fda.gov/ForConsumers
products that contain acetaminophen are
strengthened.
A number of educational programs
have been introduced to help educate
both caregivers and patients about the
changes. Ensuring that older patients
understand the changes is of special
importance. Uncertainties regarding
unintended consequences, such as
switching to other analgesics that may
be more risky for that age group, have
been raised.
As articulated by the FDA and IOM,
an interdisciplinary approach offers the
best method to meet the challenges of
pain management as a public health and
human rights issue. Health care providers
must take time to educate all patients
about acetaminophen including its
risks, the maximum recommended daily
dosage, and its widespread inclusion in
OTC products and prescription opioid
combination products.
14 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care
The Gerontological Society
of America
www.geron.org
International Association for
Hospice & Palliative Care
www.hospicecare.com/resources/
McNeil Consumer Healthcare
For Consumers
www.tylenol.com
For Professionals
www.tylenolprofessional.com
National Council on Patient
Information and Education
www.talkaboutrx.org
www.mustforseniors.org
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The Gerontological Society of America 15
[ POST-ACTIVITY QUESTIONS ]

For each question, circle the letter corresponding to the correct answer. There is only one correct answer to each question.
[ 1 ] With regard to acetaminophen and acute liver failure, [ 5 ] Prior research determined that the proportion of
acetaminophen-related overdoses: adults who take more than the recommended daily
a] A
 re the most common cause of acute liver failure in dose of analgesics is:
the United States. a] M
 ore than 70%.
b] A
 re most often intentional. b ] 44%.
c] O
 ccur when acetaminophen was reportedly taken c ] 30%.
for high fevers. d] L
 ess than 10%.
d] A
 re rarely associated with opioid-containing
products. [ 6 ] The group of older adults least likely to benefit from
the new acetaminophen labeling changes required by
[ 2 ] The FDA has elected to make which of the following the FDA, are those with:
changes to prescription products containing a ] Depression.
acetaminophen? b ] Pain, cold, or flu symptoms.
a] L
 imit opioid-acetaminophen combination products c ] Low health literacy.
to 750 mg of acetaminophen. d] C
 aregiver burden.
b] A
 black box warning will be added to prescription
acetaminophen-containing products highlighting [ 7 ] Best practice for older adults experiencing persistent
the potential for liver toxicity. pain involves:
c] A
 black box warning will be added about potential a] O
 nly psychological, behavioral, or social
allergic reactions to acetaminophen. interventions.
d] L
 imit opioid-acetaminophen combination products b ] Only pharmacological therapy.
to 500 mg of acetaminophen. c ] Multimodal therapy.
d] O
 nly alternative/complementary therapies.
[ 3 ] Comprehensive assessment of pain should always
include the following: [ 8 ] An older adult with persistent pain should be
a] A
 pain intensity measurement using verbal prescribed pain medication:
descriptors. a] O
 nly when pain occurs.
b] P
 ain measurement using a numeric scale. b ] Around the clock.
c ] A patient self-report. c] O
 nly when alternative/complementary therapies
d] A
 report from a pain management specialist. have failed.
d] O
 nly when the patient asks for medication.
[ 4 ] Inquiring about older adults’ attitudes and beliefs
about taking pain medications could help to: [ 9 ] An essential component of palliative care is:
a] T
 ake legal action against patients who may be a] O
 pioid drug therapy.
engaging in analgesic medication abuse. b ] Pain management.
b] D
 etermine why they may have been misdiagnosed. c ] Alternative pain therapies.
c ] Identify possible targets for intervention (e.g., d] S
 elf-management.
identifying myths about pain medication use).
d] U
 ncover why they may have been denied [ 10 ] Factors that have been identified to decrease analgesic
insurance coverage for their pain management. medication adherence in older adults include:
a] F
 ear of negative side effects.
b ] Concerns about addiction.
c] F
 ear of tolerance necessitating increased doses of
a pain medication.
d ] All of the above.
[ 1 ] a [ 2 ] b [ 3 ] c [ 4 ] c [ 5 ] b [ 6 ] a [ 7 ] c [ 8 ] b [ 9 ] b [ 10 ] d ANSWER KEY:

16 From Publication to Practice: An interdisciplinary look at labeling changes for acetaminophen and the implications for patient care