58 inside dentistry | March 2013 | www.dentalaegis.com/id
Michael a. cuddy, dMd
assistant Professor, dental anesthesiology
university of Pittsburgh School of dental Medicine
Jonathan Mendia, dMd
Resident, dental anesthesiology
department of dental anesthesiology
university of Pittsburgh School of dental Medicine
Paul a. MooRe, dMd, Phd, MPh
Professor, Public health and Pharmacology
chair, department of dental anesthesiology
university of Pittsburgh School of dental Medicine
for providing dental care during pregnancy,
Oral Health During Pregnancy and Early
Childhood: Evidence-Based Guidelines for
Health Professionals, states: “Prevention,
diagnosis, and treatment of oral diseases,
health and treating
dental diseases are
ponents of overall
of maternal and fetal health supports this
concept. the recently published guidelines
Re-evaluating Therapeutic Drugs
for Your Pregnant Dental Patients
Select the safest agents, limit the duration, and minimize dosages
By Jonathan Mendia, DMD | Michael A. Cuddy, DMD |
Paul A. Moore, DMD, PhD, MPH
Continuing eDuCAtion estHetiCs | iMPlAnts
Providing necessary dental treatment, managing oral infection, and controlling pain are
essentials to help patients maintain overall health during pregnancy. the therapeutic
drugs routinely used in dental practice are selected because of their known safety and
effectiveness. However, for a pregnant patient requiring dental care, the agents routinely
prescribed should be re-evaluated for potential risks to the mother and/or fetus. the
decision to administer a specific drug requires that the benefits outweigh the potential
risks of the drug therapy. this article reviews and updates the recommendations for us-
ing dental therapeutic agents to help general practitioners select the safest drugs when
treating their pregnant patients.
including needed dental radiographs and use
of local anesthesia, are highly beneficial and
can be undertaken during pregnancy with
no additional fetal or maternal risk when
compared to the risk of not providing care.
Good oral health and control of oral disease
protects a woman’s health and quality of life;
and has the potential to reduce the transmis-
sion of pathogenic bacteria from mothers to
their children.”1 Clearly, the health benefits
of providing needed dental care during preg-
nancy far outweigh the potential risks.
For the young healthy adult dental patient,
the selection of dental therapeutic agents for
local anesthesia, sedation, postoperative pain
control, and treatment of infections is usually
straightforward. A dental practitioner might
routinely select lidocaine with epinephrine,
triazolam, ibuprofen, or acetaminophen with
hydrocodone and penicillin V.2,3 Alternative
agents may be necessary to safely treat pa-
tients who have a history of drug allergy, as
well as those who are medically compromised,
at age extremes, or taking concomitant medi-
cations. For a pregnant patient, a dentist must
consider the additional risks drug therapy
may have for the mother and fetus.
drug therapy during pregnancy should aim
to avoid adverse drug reactions to either the
mother or the fetus. Hypersensitivity, aller-
gy, or toxicity reactions by the mother may
compromise her health and limit her abili-
ty to support a pregnancy. Adverse drug ef-
fects specific to the health of the fetus may
include congenital defects, miscarriage, de-
livery complications, low birth weight, and
postnatal drug dependence. these effects are
60 inside dentistry | March 2013 | www.dentalaegis.com/id
inside Continuing eDuCAtion
usually specific to the timing of drug adminis-
tration during pregnancy (ie, first, second, or
third trimester), the dose given, and the du-
ration of therapy. Compared to many medi-
cal therapies, dental treatment generally in-
volves use of drugs with short elimination
half-lives, which are administered for lim-
ited periods of time and are, therefore, less
likely to cause complications.
Physiologic changes during pregnancy in-
clude weight gain, positional hypotension
when placed supine, a frequent need to uri-
nate, restricted respiratory function, and a
potential for hypoglycemia. Morning sick-
ness is also common. Pregnancy may inten-
sify the stress and anxiety of a dental appoint-
ment. dental care during pregnancy should
make accommodations for these chang-
es through short appointments, avoidance
of prolonged supine positioning, clear oral
hygiene instructions, and judicious use of
A decrease in blood pressure and cardiac out-
put may occur while the pregnant patient is in a
supine position, particularly during the second
and third trimesters.5 this has been attributed
to decreased venous return to the heart as a re-
sult of compression of the inferior vena cava
by the gravid uterus, resulting in a reduction
of cardiac output.6,7 this condition is known as
supine hypotensive syndrome and is character-
ized by lightheadedness, hypotension, tachy-
cardia, and syncope. the treatment is to place
the patient in a 5º to 15º left lateral position to
reduce the uterine pressure on the vena cava
and administer 100% oxygen. if the hypoten-
sion is still not relieved, a full left lateral posi-
tion is indicated.8
Pregnant women are at increased risk of
pregnancy gingivitis, tooth mobility, dental
caries, and erosion. Pregnancy gingivitis, the
most common oral manifestation in preg-
nant women, is caused by elevated estrogen
and progesterone levels, leading to increased
capillary permeability during pregnancy.9
Pregnant patients experience gum irritation,
weakening of tooth enamel, and dental car-
ies due to the increased acidic exposure from
morning sickness and gastroesophageal reflux
disease (Gerd). Preventative care through
periodontal treatment and proper oral hy-
giene can help prevent such occurrences.
Although most elective dental procedures
can be postponed, treatment of a pregnant
patient presenting with oral pain, advanced
disease, or infection should not be delayed.
effective oral hygiene instructions should
be provided to the pregnant patient, describ-
ing the importance of plaque control in pre-
vention of periodontal disease. if emergency
62 inside dentistry | March 2013 | www.dentalaegis.com/id
inside Continuing eDuCAtion
treatment is indicated, it should be performed
at any time to eliminate any physical stress
to the patient or fetus. Although none of the
drugs used to treat pain and infection are to-
tally without risk, the consequences of not
treating an active infection during pregnan-
cy far outweigh the potential risks of most of
the drugs required for dental care.
Pregnancy Risk categories
the Food and drug Administration (FdA)
established 5 categories for classifying po-
tential pregnancy risks associated with drug
therapy.10 these categories, defined in table 1,
provide a guide for the relative safety of drugs
prescribed to pregnant patients. Category A
includes drugs that have been adequately
studied in humans and have evidence sup-
porting their safe use. drugs in Category B
have no evidence of risk in animal studies
or human therapeutic use. Category C in-
cludes drugs where teratogenicity risk has
been demonstrated in animals and cannot
be ruled out in humans. Category d includes
drugs that have demonstrated risks in hu-
mans, but their therapeutic benefit may out-
weigh the risks, while Category X includes
agents that have been shown to be harmful
to the mother or fetus with an unfavorable
drugs in categories A and B are generally
considered appropriate for use during preg-
nancy, while Category C drugs should be
used with caution; drugs in categories d and
X should be avoided or are contraindicated.
Fewer than 20% of all drugs classified by the
FdA are in categories A or B.11,12 information
provided within the manufacturers’ package
inserts included with prescription and non-
prescription drugs include these FdA use-
in-pregnancy ratings. the FdA is current-
ly revising the labeling requirements for use
of prescription drugs during pregnancy to
provide a more complete description of spe-
cific risk; source of information (animal or
human); the likelihood of specific develop-
mental abnormalities and their seriousness,
reversibility, and correctability; and the im-
portance of dose, duration of exposure, and
gestational timing of exposure.13
Of the thousands of drugs marketed, only a
few are known with certainty to be terato-
genic (induce birth anomalies) in humans.
thalidomide, which was developed in the
1950s as a tranquilizer and antiemetic, is the
best-known human teratogen. thalidomide’s
teratogenesis is unusual because, when tak-
en in the first 3 months of gestation, there is
a high incidence of birth defects, including
a unique anomaly called phocomelia, which
is characterized by shortened arms and legs.
Warfarin, retinoids, valproic acid, and heavy
metals are also known to produce significant
physical birth defects. Knowledge of the risks
associated with drug use during pregnancy is
most clear when the frequency of birth de-
fects is high and the outcome is easily iden-
tified. Adverse effects of drug therapy during
pregnancy that are subtle and delayed, such
as minor changes in behavior and intelli-
gence, are nearly impossible to determine.14,15
Many factors may contribute to uncertain-
ty when determining the risk of drug thera-
py. Animal data, which are usually collected
from studies that use extraordinarily high
and prolonged exposures, are known to have
marked species variability. some congenital
defects, such as cleft lip—with or without cleft
palate—have high background rates, which
complicate the assessment of added risk for
any specific drug.16 the teratogenic potential
for some drugs may depend on a genetic pre-
disposition involved in fetal development.14
Additionally, when multiple birth defects
are reported, it is often difficult to determine
whether the etiologic factor was the drug or
the underlying disease requiring drug therapy.
Accurate human risk assessment is impos-
sible to obtain for many newly marketed or
infrequently prescribed drugs. Fortunately,
the therapeutic agents used in dental prac-
tice are used quite frequently, and evidence is
available to evaluate their potential risk (view
table 2 online at www.dentalaegis.com/go/
id582). in recent years, new agents have come
to the market and some changes have occurred
to the previous risk classifications. this updat-
ed drug listing provides a summary of the cur-
rent understanding of risk during pregnancy.
Selection of dental
Most local anesthetics have not been shown
to be teratogenic in humans and are consid-
ered relatively safe for use in dentistry. the
recommendation for caution (Category C)
for mepivacaine and bupivacaine relates
primarily to limited data collected in ani-
mal teratogenicity studies. As such, possible
birth defects in humans cannot be ruled out
for these agents. in animal studies, fetal bra-
dycardia can result from high concentrations
of lidocaine, bupivacaine, or mepivacaine in-
jected in the vicinity of the umbilical artery.17
Because all local anesthetics can cross the
placenta and cause fetal depression, limit-
ing the anesthetic dose to the minimum re-
quired for effective pain control is advisable.
Lidocaine, the local anesthetic agent most
commonly used, has a maximum recom-
mended dose of 4.3 mg\kg without a vaso-
constrictor and 7mg\kg with a vasoconstric-
tor.18 diluted blood volume and decreased
protein binding during pregnancy may low-
er the maximum safe dosage. intravascular
injection combined with decreased pro-
tein binding could conceivably increase lo-
cal anesthetic toxicity. However, the maxi-
mum recommended local anesthetic doses
used in dentistry are very conservative and
unlikely to reach significant fetal blood lev-
els.1,5 A limited dose of bupivacaine may be
a valuable alternative to postoperative non-
steroidal anti-inflammatory drugs (nsAids)
and opioid analgesics for postoperative pain
management in pregnant patients.
the most convincing evidence of local an-
esthetic safety is the Collaborative Perinatal
Project (CPP). it was conducted from 1960 to
1994 at 12 university hospitals throughout the
United states, examining prenatal exposure
to various drugs and environmental factors.
the study tracked 55,000 children, creating
a large database. no evidence of teratogenic-
ity or other adverse outcomes was noted from
the appropriate use of benzocaine, procaine,
tetracaine, or lidocaine in pregnancy.19
Prilocaine and benzocaine are recog-
nized as inducers of methemoglobinemia. in
64 inside dentistry | March 2013 | www.dentalaegis.com/id
inside Continuing eDuCAtion
and prilocaine to avoid a potential methemo-
globinemia would be prudent.
Epinephrine and Vasoconstrictors
An inadvertent intravascular injection of a
1.8-mL cartridge of local anesthetic formu-
lation containing 1:100,000 epinephrine can
deliver 18 μg of epinephrine. Clinically sig-
nificant intravascular doses of α-adrenergic
agents are to be avoided in order to maintain
appropriate placental perfusion and fetal vi-
ability.20,21 normally used dental dosages of
local anesthetics with vasoconstrictors, with-
out inadvertent intravascular injection, do
not expose the fetus or uterus to significant
levels of epinephrine. When administering
a dental anesthetic containing epinephrine,
it is imperative that it be injected slowly, us-
ing repeated aspiration. Vasoconstrictors de-
crease the toxicity of local anesthetics by de-
creasing absorption. there are no significant
contraindications for the use of epinephrine
in the recommended dosages, provided intra-
vascular injection does not occur.1,5
epinephrine improves local anesthesia, re-
ducing peak blood levels of local anesthetics
and prolonging neural blockade. epinephrine
in the blood has dose-related effects on uter-
ine blood flow and contractility, causing both
a decrease in blood flow and uterine activi-
ty. epinephrine can also cause constriction
of the umbilical artery, but it has been dem-
onstrated to be of possible significance only
when there is fetal compromise.20 in general,
there does not appear to be any significant
contraindication for the careful use of lido-
caine with epinephrine in pregnant patients.1
Levonordefrin, another vasoconstrictor
used in local anesthetic solutions, has phar-
macologic activity similar to epinephrine. in
equal concentrations, levonordefrin is less
potent than epinephrine in raising blood
pressure or as a vasoconstrictor. However, in
dental cartridges, the concentration of levo-
nordefrin (1:20,000) is five times the normal-
ly employed concentration of epinephrine
(1:100,000). this higher concentration of le-
vonordefrin is a more potent vasoconstrictor,
and, therefore, carries a higher risk to the fe-
tus. thus, levonordefrin is a poor choice for
the pregnant patient.5
Aspirin and nsAids have the common
mechanism of inhibiting prostaglandin syn-
thesis. Prostaglandin e2 is one of the hor-
mones involved in the induction of labor.
By blocking the production of prostaglan-
dins, nsAids may prolong labor. in addi-
tion, prostaglandin inhibitors raise concerns
about premature fetal ductus arteriosus con-
stricture, resulting in pulmonary hyperten-
sion in the fetus. these concerns were de-
rived from studies on patients taking large
doses of aspirin and extrapolated to apply
to other nsAids.22 there may be a slightly
methemoglobinemia, hemoglobin iron at-
oms are oxidized to a ferric state and will not
carry oxygen to the same degree as normal.
if severe, maternal anoxia would be poten-
tially lethal to the fetus as well as the mother.
A large dose of these two local anesthetics
in a susceptible patient could theoretically
cause a crisis. in patients who have no oth-
er toxic exposure or genetic defect, the dose
of prilocaine to induce methemoglobinemia
usually exceeds the maximum recommend-
ed dose for significant oxidation of hemoglo-
bin iron.20 Although there have been no pub-
lished reports in the literature of any added
hazard to mother or fetus compared to other
anesthetics, limiting the dose of benzocaine
use-in-Pregnancy Ratings For dental drugs10
CatEgOry a: COntrOLLEd studiEs shOw nO risk
CatEgOry b: nO EvidEnCE Of risk in humans
CatEgOry C: risk CannOt bE ruLEd Out
CatEgOry d: POsitivE EvidEnCE Of risk
CatEgOry X: COntraindiCatEd in PrEgnanCy
66 inside dentistry | March 2013 | www.dentalaegis.com/id
increased risk of congenital anomalies, in-
cluding cardiac defects, when nsAids—such
as ibuprofen, naproxen, or celecoxib—are
taken early in pregnancy as well.23
newborns of mothers who have ingested 5
g to 10 g of aspirin 5 days before delivery are
associated with bleeding tendencies, specifi-
cally intracranial hemorrhage. no bleeding
tendencies were found if aspirin was taken no
fewer than 6 days prior to delivery.24 Aspirin
and other nsAids should be avoided, espe-
cially during the third trimester of pregnancy.
the alternative to aspirin and other nsAids
is acetaminophen, which causes less gastric
irritation and does not cause bleeding tenden-
cies. the dosage of acetaminophen should be
closely monitored to preclude potential he-
Centrally Acting Analgesics
the opioid analgesics should be used cau-
tiously and only when indicated. the use of
codeine during pregnancy has been evaluat-
ed as part of the large Collaborative Perinatal
Project. this prospective study monitored
pregnancies for possible drug-related birth
defects and toxicities. the results suggest
that codeine is associated with multiple con-
genital defects, including heart defects and
cleft lip/palate.26-27 Because other opioids,
such as oxycodone and hydrocodone, are
administered infrequently during pregnan-
cy, little is known about their potential fetal
risks. the medical disorders that necessi-
tated the use of these opioids may also have
induced these defects. neonatal respirato-
ry depression as well as opioid withdrawal
has also been reported with opioid use.28 the
prolonged or high-dose use of opioids signifi-
cantly increases these risks when used late
the penicillin and cephalosporin antibiotics
most commonly used in dentistry (penicil-
lin V, amoxicillin, and cephalexin) are gen-
erally considered safe for use during preg-
nancy. Clindamycin, metronidazole, and
erythromycin are also believed to have min-
imal risk. the estolate salt of erythromycin
may be more likely to induce hepatic toxic-
ity in a pregnant mother and is, therefore,
not recommended.29 the greatest concerns
regarding antibiotic use are with agents
that have limited indications in dentistry.
Aminoglycosides, such as gentamicin, may
induce ototoxicity when administered late in
pregnancy. tetracyclines, including doxycy-
cline, have been implicated in causing tooth
discoloration and impaired bone metabolism.
the use of any of the central nervous system
depressants commonly used for sedation ther-
apy is problematic. Because sedative agents
are neuronal function inhibitors and gener-
ally cross-placental barriers, their use during
pregnancy is viewed with apprehension. Of the
anti-anxiety drugs commonly prescribed, the
benzodiazepine diazepam (Valium) has been
most frequently assessed. Both animal and hu-
man investigations have noted an association
between diazepam exposure during pregnancy
and oral clefts.30,31 yet, confirmation of these
reports has not always been possible. A single-
dose exposure with clinically acceptable doses,
as compared with chronic therapy throughout
a pregnancy, would suggest minimal risk for
teratogenicity following benzodiazepine seda-
tion/anesthesia. Overall, the evidence cautions
against the prolonged use of benzodiazapines,
particularly during pregnancy.
Nitrous Oxide and Anesthesia
Prolonged high-dose exposure to nitrous ox-
ide in rats has demonstrated skeletal and be-
havioral teratogenic effects.32,33 in addition,
spontaneous abortions and reduced fertility
have been implicated with occupational ex-
posure to nitrous oxide.34 nitrous oxide can
inactivate vitamin B12 and thereby inhibit
the vitamin B12-dependent enzyme methio-
nine synthetase. this inhibition is known to
deplete tetrahydrofolate levels that are nec-
essary for dnA synthesis.
Prolonged exposure to ambient concen-
trations of nitrous oxide could conceivably
inhibit cell division. short exposure during
general anesthesia with such agents as ni-
trous oxide, halothane, and thiopental are
not thought to be teratogenic.1 However, be-
cause prolonged exposure to nitrous oxide
has been demonstrated to inhibit cell repli-
cation, minimizing long appointments using
n2O—particularly during the first trimester—
would seem indicated.
Pregnancy complications and birth defects
caused by alcohol, tobacco, or illicit drug use
are completely preventable. Practitioners
should advise women to stop the use of all
these substances immediately upon planning
to become pregnant or are pregnant.
Alcohol consumption during pregnancy is a
significant health concern. no amount of al-
cohol consumption has been proven safe or
can be considered safe during pregnancy. the
Us surgeon General recommends complete
abstinence from alcohol for all women who
are pregnant or are planning a pregnancy.35
Many women are unaware that any alcohol
consumption during pregnancy can result in
harm to the fetus. According to the Centers
for disease Control and Prevention, 1 in 12
pregnant women drink, and approximately 1
in 30 pregnant women report binge drinking
(5 or more alcoholic drinks on one occasion).36
Alcohol consumption during pregnancy in-
creases the risks of premature birth, stillbirth,
and miscarriage.37,38 neonatal effects include
mental retardation, skeletal abnormalities,
organ malformations, low birth weight, learn-
ing problems, and fetal alcohol syndrome.
tobacco use during pregnancy is also asso-
ciated with adverse birth outcomes, includ-
ing ectopic pregnancy, spontaneous abortion,
placental abruption, placental previa (a low-
lying placenta that covers the uterus), pre-
term delivery, stillbirth, and low birth weight.
the detrimental effects of smoking extend to
the lives of the infants born to women who use
tobacco during pregnancy, and include cleft
lip or palate, prematurity, low birth weight,
neonatal mortality, and sudden infant death
syndrome (sids).39 Almost one-quarter of
all sids deaths may be attributed to prenatal
maternal smoking, and fetal mortality rates
are 35% higher among pregnant women who
smoke compared to those who do not.40
inside Continuing eDuCAtion
68 inside dentistry | March 2013 | www.dentalaegis.com/id
in the United states, approximately 4%
of pregnant women use illicit drugs, includ-
ing marijuana, heroin, cocaine, and amphet-
amines.41 illicit drug use by pregnant women
can cause serious problems in the developing
fetus and newborn. the growth of the fetus is
greatly impacted, premature births are more
common, and the transmission of sexually
transmitted diseases and hepatitis can occur.
Maintaining a healthy lifestyle, including
optimal oral health, is essential for women who
are currently pregnant or planning to become
pregnant. dental practitioners should provide
all necessary care for pregnant patients, par-
ticularly when managing an acute infection.
drug and chemical exposure during preg-
nancy is believed to account for about 1% of
congenital malformations.42 However, deliv-
ery complications and birth defects associat-
ed with pregnancy are more commonly due
to poor nutrition, smoking and alcohol con-
sumption, diseases, genetic predisposition,
and maternal age.15
When dental treatment is necessary to
maintain oral health, selecting the safest
agents, limiting the duration of the drug regi-
mens, and minimizing dosages are the funda-
mental principles for safe therapy.
1. California dental Association Foundation. Oral
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Pharmacology. new york, ny: Churchill Livingstone;
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72 inside dentistry | March 2013 | www.dentalaegis.com/id
adverse drug effects are usually specific to the:
the treatment for supine hypotensive syndrome is to place
the patient in a 5º to 15º left lateral position to:
which fda category includes drugs where risk has been
demonstrated in animals and cannot be ruled out in humans?
what percent of all of the drugs classified by the fda are in
categories a or b?
because all local anesthetics can cross the placenta and
cause fetal depression:
an inadvertent intravascular injection of a 1.8-mL cartridge
of local anesthetic formulation containing 1:100,000
epinephrine can deliver:
the penicillin and cephalosporin antibiotics most commonly
used in dentistry are:
Prolonged exposure to nitrous oxide has been demonstrated to:
how much alcohol consumption during pregnancy has been
proven or can be considered safe?
approximately how many pregnant women use illicit drugs?
to take this quiz, log on to www.dentalaegis.com/id
or fill out and mail the answer form on the next page.
Re-evaluating Therapeutic Drugs for Pregnant Dental Patients
By Jonathan Mendia, DMD; Michael A. Cuddy, DMD; and Paul A. Moore, DMD, PhD, MPH
AeGis Publications, LLC, provides 2 hours of Continuing education credit for this article. We are pleased to offer two options for participating in this Ce lesson.
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Please complete the answer form on page 74, including your name and payment information.
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dentistry. Concerns or complaints about a CE provider may be directed
to the provider or to ada CErP at www.ada.org/cerp.
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does not imply acceptance by a state or provincial board of
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re-evaluating therapeutic drugs for Pregnant dental Patients
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