Download Prescribing for Pregnant or Lactating Women

Disclosure Statement
Dr. Jankowski has no financial relationships with any commercial interests.
Prescribing for Pregnant or Lactating Women
March, 2013
RoseAnn L. Jankowski, Pharm.D.
Prescribing for Pregnant or Lactating Women
Educational Objectives
At the conclusion of this educational activity, participants should be able
to:
• describe the FDA Pregnancy Risk Factor Categories.
• outline and discuss general considerations for increasing the safety
of medications prescribed for women who are pregnant or
breastfeeding an infant.
• state the pregnancy and lactation status of medications commonly
prescribed under the optometrist scope of practice.
Prescribing for Pregnant or Lactating Women
Introduction: Why is this information important?
• There is sometimes a mistaken impression that drugs administered
topically in the eye are not absorbed systemically and never
present a potential risk to the fetus or infant when used by a
woman who is pregnant or breastfeeding
• Nearly all therapeutic drugs administered to or taken by a woman who is
pregnant can cross the placenta.
Prescribing for Pregnant or Lactating Women
Introduction: Why is this information important?
Two patient groups requiring special consideration by optometrists when
prescribing topical or oral (systemic) medications are women who are
pregnant and women who are breastfeeding an infant.
• Many optometrists have had minimal training in specifically prescribing
for these patient groups
• Pregnancy risk factor ratings can be difficult to quickly locate and to
interpret
• Fewer studies have been done and less is generally known about drug
use while breastfeeding than when using medications during
pregnancy.
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
• The major factor contributing to the concentration of drug in the fetus is
the concentration of drug present in the mother.
Other contributing factors include:
- gestational age of the fetus
- the degree of placental development (placental blood flow
volume and surface area)
- drug molecular size
• Depending on pharmacologic factors and drug properties, drugs that
cross the placenta can reach different concentrations in the
developing fetus.
- lipid solubility of the drug
- protein binding characteristics of the drug
- degree of drug ionization in the environment of
physiologic pH
This includes ophthalmic medications.
1
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
• Teratogenic effects resulting in fetal malformations are known to be both:
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
•Teratogenic effect studies conducted in animals may not always be directly
relatable to potential effects in humans.
- dose related (how much drug)
- time related (when, and for how long the drug exposure occurs)
• The period of greatest risk for malformations to occur or originate is
within the first three months of gestation, however anatomic,
functional or behavioral effects can occur throughout the entire
gestational period.
• Studies conducted in humans often cannot fully address all possible areas
or types of human risk, including genetic differences in populations.
• Other specific risk factor elements include
- dose-related effects
- the pharmacokinetic properties of each drug
- potential maternal or fetal disease states
- the specific stage of pregnancy involved
- the timing of drug exposure
- the degree of drug exposure over time.
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
To best address all of these potential concerns, recommendations for drug
use during pregnancy are often criteria-based using data and results from
available studies. These criteria often include:
- what (if any) information is known from studies conducted in
humans and/or animals
- if the nature of the study data is limited or extensive
- whether the data is suggestive of risk (and if so, if the risks would
be considered to be low, moderate, or high)
- whether the data indicates any trimester-specific findings or
cautions
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
One of the most common criteria-based systems describing potential drugrelated fetal risk is the Pregnancy Risk Factor rating assigned by the U.S.
Food and Drug Administration (FDA).
These rating categories relate to risk factors which are assigned based on
the level of known risk that each drug presents to the fetus.
While the assigned risk factor rating can assist a prescriber in an initial
determination of safety for the fetus, the rating should be considered as a
starting point only.
- whether any results suggest that a drug should be considered
contraindicated for use during pregnancy.
NOTE:
- FDA Pregnancy Risk Factors do
NOT include lactation risks.
- Not all currently available drugs
have ratings.
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
FDA PREGNANCY RISK FACTOR CATEGORIES
Based on submitted clinical study information reviewed as part of the drug
approval process, the Food and Drug Administration (FDA) assigns one of
five pregnancy risk factors based on the degree of risk that use of the drug
would potentially cause to the fetus.
Category A
Category B
Controlled studies in pregnant women fail to demonstrate a
risk to the fetus in the first trimester (and there is no
evidence of a risk in later trimesters), and the possibility of
fetal harm appears remote.
Either animal-reproduction studies have not demonstrated
fetal risk but there are no controlled studies in pregnant
women, or animal-reproduction studies have shown
adverse effect (other than a decrease in fertility) that was
not confirmed in controlled studies in women in the first
trimester (and there is no evidence of a risk in later
trimesters.)
FDA PREGNANCY RISK FACTOR CATEGORIES
Category C
Either studies in animals have revealed adverse effects on
the fetus (teratogenic or embryocidal or other) and there
are no controlled studies in women, or studies in women
and animals are not available. Drugs should be given only if
the potential benefit justifies the potential risk to the fetus.
Category D
There is positive evidence of human fetal risk, but the
benefits from use in pregnant women may be acceptable
despite the risk (e.g. if the drug is needed in a lifethreatening situation or for a serious disease for which
safer drugs cannot be used or are ineffective.)
Category X
Studies in animals or human beings have demonstrated
fetal abnormalities or there is evidence of fetal risk based
on human experience or both, and the risk of the use of the
drug in pregnant women clearly outweighs any possible
benefit. The drug is contraindicated in women who are or
may become pregnant.
2
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Pregnant
Reviewing the FDA Pregnancy Risk Factor rating does not address the
safety of using the drug while breast-feeding, and should be followed by the
prescriber considering other important factors such as:
- gestational stage
Prescribing Considerations for Women Who Are Breastfeeding
• Clinical information concerning the safety of drug use while breast-feeding
an infant is often more limited than information regarding the safe
use of drugs during pregnancy.
- more detailed risk information
- individual factors such as other medical conditions that the
mother may have.
The BEST use of FDA Pregnancy Risk Factor ratings would be for the
optometrist to contact the physician directly supervising the patient’s
pregnancy to discuss the rating and the advisability of proceeding with the
proposed therapy given the patient’s stage of pregnancy, general health, etc.
• Many published studies of drug use during lactation have been conducted
in animals. Comparisons between accumulated drug
concentrations in animals can be difficult to make with certainty in
humans. This difficulty arises because of significant differences
which exist between the compositions of breast milk between
different species.
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Prescribing Considerations for Women Who Are Breastfeeding
•Studies have also indicated that drug concentration in breast milk can also
be affected by drug characteristics including lipid solubility, protein
binding ability, and degree of ionization.
• Also complicating assessments of safety is the overall lack of definitive
information on manifested or measured pharmacologic effects in
infants when drugs have been ingested through breast milk.
General Pregnancy and Lactation Information for Drugs Under the
Optometry Scope of Practice
• Relative recommendations and cautions regarding drug use while breastfeeding can be found in medical literature, however prescribers are
always advised to conduct a risk to benefit assessment and to seek
the advice or opinion of the physician directly supervising the
patient’s post-natal care prior to prescribing medications to women
who are breastfeeding an infant.
• Prescribers should look for breastfeeding compatibility ratings from the
American Academy of Pediatrics (AAP).
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
C
No reports of
fetal
complications
during
pregnancy.
Is excreted in
breast milk, use
with caution in a
lactating
woman.
Use in the eye
produces measurable
amounts in systemic
circulation. Expect
transmission to the
fetus.
Fluorexon
No US FDA
rating is
available.
Unknown if drug
is excreted into
breast milk.
Not known if drug can
cause fetal harm.
Lissamine Green
No US FDA
rating is
available.
No information
Little information
available. Use only
when clearly indicated.
Rose Bengal
No US FDA
rating is
available.
No information
Little information
available. Use only
when clearly indicated.
Fluorescein
Comments
Drug
Proparacaine
Pregnancy
Category
C
Safe use not
established
Lidocaine
B
Use not
associated with
any risks, but
caution should be
used.
Tetracaine
C
Should be used
only if the
potential benefit
justifies the
potential risk to
the fetus.
Breastfeeding
Information
Comments
No information,
safe use not
established.
Use only when
clearly needed and
when potential
benefits outweigh
potential risks.
AAP Rating:
Maternal
medication usually
compatible with
breastfeeding.
Local anesthetics
generally cross
into breast milk,
concentrations
usually 40% of
serum levels.
WHO: “Compatible Low molecular wt.
with breast
suggests drug can
feeding.”
cross the placenta
and will be
excreted into
breast milk.
3
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Phenylephrine
C
Safe use has not
been established.
Use only if clearly
needed and
potential benefit
outweighs
potential fetal risk.
Not known if drug
is excreted into
breast milk.
Exercise caution
during lactation.
Comments
Atropine,
Homatropine
C
Safe use has not
been established.
Use only if clearly
needed.
May be detectable
in breast milk, but
AAP lists these
drugs as being
compatible with
breastfeeding.
Exercise caution
during lactation.
Cyclopentolate
C
Safe use has not
been established.
Use only if clearly
needed.
Not known if drug
is excreted into
breast milk.
Exercise caution
during lactation.
Drug
Tropicamide
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding
Information
Comments
Naphazoline
C
Inconclusive
information at this
time.
Use only when
clearly needed and
when potential
benefits outweigh
potential risks.
Unknown
Safe use for
pregnancy or in
lactation is not
known.
Inconclusive
information at this
time.
Use only when
clearly needed and
when potential
benefits outweigh
potential risks.
Inconclusive
information at this
time.
Safe use for
pregnancy or in
lactation is not
known.
No US FDA rating
is available.
Phenylephrine
C
Tetrahydrozoline
No US FDA rating
is available.
Azelastine
(Optivar®)
A/MCS
Cromolyn
(Crolom®,
Opticrom®)
MCS
Emedastine
(Emadine®)
A
Epinastine
(Elestat®)
A/MCS
Drug
A/MCS
Lodoxamide
(Alomide®)
MCS
Nedocromil
(Alocril®)
MCS
Alcaftadine
(Lastacaft®)
A/MCS
Breastfeeding
Information
Comments
Not known if drug
is excreted into
breast milk. Use
only if potential
benefit outweighs
potential fetal risk.
Pregnancy
Category
Breastfeeding
Information
Comments
C
Use during
pregnancy only if
potential benefit
justifies potential
fetal risk.
Not known if drug is
excreted into breast
milk.
Teratogenic
effects in mice at
high levels noted.
B
Use during
pregnancy only if
clearly needed.
Not known if drug is
excreted into breast
milk.
Exercise caution
during lactation.
B
Use during
pregnancy only if
clearly needed.
Not known if drug is
excreted into breast
milk after topical use.
Exercise caution
during lactation.
C
Use only if
potential benefit
justifies potential
fetal risk.
Not known if drug
crosses into human
breast milk. Exercise
caution during
lactation.
Animal studies
showed some
effects at higher
than human
doses.
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Ketotifen
(Alaway®,
Zaditor®)
C
Use only if potential
benefit outweighs
potential fetal risk.
Prescribing for Pregnant or Lactating Women
Drug
Oxymetazoline
Pregnancy Category
Pregnancy
Category
Breastfeeding
Information
C
Use only if
potential benefit
justifies potential
fetal risk.
Not known if drug
crosses into
human breast
milk. Exercise
caution during
lactation.
Animal studies
showed some
effects at higher
than human
doses.
Comments
B
Use during
pregnancy only if
clearly needed.
Not known if drug
is excreted into
breast milk.
Exercise caution
during lactation.
B
Use during
pregnancy only if
clearly needed.
Not known if drug
crosses into
human breast
milk.
Exercise caution
during lactation.
B
Use during
pregnancy only if
clearly needed.
Not known if drug
is excreted into
breast milk.
Exercise caution
during lactation
Drug
Olopatadine
(Patanol®,
Pataday®)
A/MCS
Pemirolast
(Alamast®)
MCS
Bepotastine
(Bepreve®)
A/MCS
Pregnancy
Category
Breastfeeding
Information
C
Use only if
potential benefit
justifies potential
fetal risk.
Not known if drug
crosses into
human breast
milk.
Exercise caution
during lactation.
Comments
C
Use only if
potential benefit
justifies potential
fetal risk.
Not known if drug
crosses into
human breast
milk. Exercise
caution during
lactation.
Animal studies
showed some
effects at higher
than human
doses.
C
Use only if
potential benefit
justifies potential
fetal risk.
Not known if drug
crosses into
human breast
milk. Exercise
caution during
lactation.
Animal studies
showed some
effects at higher
than human
doses.
4
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Dexamethasone
C
Use only when
clearly needed and
when potential
benefits to the
mother outweigh
potential fetal
risks
Sources
recommend that a
decision should
be made to
discontinue
nursing or
discontinue the
drug.
Topically applied
steroids are
absorbed
systemically.
Difluprednate
(Durezol®)
C
Use only when
clearly needed and
when potential
benefits to the
mother outweigh
potential fetal
risks
Unknown whether
topical drug is
excreted into
breast milk.
Exercise caution
during lactation.
Topically applied
steroids are
absorbed
systemically.
Drug
Pregnancy
Category
Breastfeeding
Information
Fluorometholone
(FML®, Flarex®)
C
Use only when
clearly needed and
when potential
benefits to the
mother outweigh
potential fetal
risks
Sources
recommend that a
decision should
be made to
discontinue
nursing or
discontinue the
drug.
Loteprednol
(Lotemax®,
Alrex®)
C
Use only when
clearly needed and
when potential
benefits to the
mother outweigh
potential fetal
risks
Unknown whether
topical drug is
excreted into
breast milk.
(Note: Ophthalmic prednisolone products are all Category C, with no
known lactation information.)
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding
Information
C
Use only when
clearly needed and
when potential
benefits to the
mother outweigh
potential fetal
risks
Sources
recommend that a
decision should
be made to
discontinue
nursing or
discontinue the
drug.
Bromfenac
(Xibrom®)
C
Use should be
avoided during
late pregnancy
due to potential
fetal cardiac risk
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use only if
potential benefit
outweighs
potential fetal risk.
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use only if
potential benefit
outweighs
potential fetal risk.
Comments
Pregnancy
Category
Breastfeeding
Information
Diclofenac
(Voltaren®)
Drug
C
Molecular weight
low enough that
excreted into
breast milk should
be expected.
Infant risk cannot
be ruled out.
Although one
source lists
diclofenac as
being compatible
with breast
feeding, caution
during lactation
should still be
exercised.
Nepafenac
(Nevanac®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use only if
potential benefit
outweighs
potential fetal risk.
Prescribing for Pregnant or Lactating Women
Drug
Ketorolac
(Acular®, Acular
LS®)
Pregnancy
Category
C
Use during
pregnancy only if
the potential
benefit justifies
the potential risk
to the fetus. Use
should be avoided
during late
pregnancy due to
potential fetal
cardiac risk
Breastfeeding
Information
Exercise caution
when considered
for use during
breast feeding.
Exercise caution
during lactation.
Prescribing for Pregnant or Lactating Women
Rimexolone
(Vexol®)
Flurbiprofen
(Ocufen®)
Comments
Comments
Prescribing for Pregnant or Lactating Women
Comments
Exercise caution
in using this drug
especially during
pregnancy.
Drug
Cyclosporine
(Restasis®)
Pregnancy
Category
C
Administer during
pregnancy only if
very clearly
needed.
Breastfeeding
Information
Oral cyclosporine
is excreted into
human breast
milk, but no
definitive safety
recommendation
is currently
available for
topically applied
drug.
Comments
Exercise caution
in using this drug
during lactation.
5
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Dipivefrin
(Propine®)
B
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
lactation only if
potential benefit
outweighs
potential fetal risk.
Apraclonidine
(Iopidine®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy and
lactation only if
potential benefit
outweighs
potential
fetal/infant risks.
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy and
lactation only if
potential benefit
outweighs
potential
fetal/infant risks.
Brimonidine
(Alphagan P®)
B
Drug
Breastfeeding
Information
Comments
Echothiophate
(Phospholine
Iodide®)
C
Because of
potential for
serious effects in
nursing infants, a
decision should
be made to
discontinue drug
or discontinue
nursing.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk.
Pilocarpine
(IsoptoCarpine®)
C
Drug is expected
to cross into
breast milk. Infant
risk cannot be
ruled out.
Use during
lactation only if
potential benefit
outweighs
potential fetal risk.
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Pregnancy
Category
Breastfeeding
Information
Comments
Betaxolol
(Betoptic®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk.
Metipranolol
(Optipranolol®)
Drug
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
lactation only if
potential benefit
outweighs
potential fetal risk.
Carteolol
(Ocupress®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk
Timolol
(Timoptic®)
C
Levobunolol
(Betagan®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk
Drug is detectable
in human milk
after ophthalmic
administration.
Infant risk is
possible.
Because of
potential for
serious effects in
nursing infants, a
decision should
be made to
discontinue drug
or discontinue
nursing.
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding
Information
Acetazolamide
(Diamox®)
C
The AAP states that
the drug is
compatible with
breastfeeding.
Brinzolamide
(Azopt®)
C
Not known if drug is
excreted into breast
milk. Infant risk
cannot be ruled out.
Prescribing for Pregnant or Lactating Women
Comments
Drug
Dorzolamide
(Trusopt®)
Because of
potential for
serious effects in
nursing infants, a
decision should be
made to
discontinue drug
or discontinue
nursing.
Methazolamide
(Neptazane®)
Pregnancy
Category
Breastfeeding
Information
C
Use during
pregnancy only
if potential
benefit
outweighs
potential fetal
risk.
Not known if drug is
excreted into breast
milk. Infant risk
cannot be ruled out.
C
Not known if drug is
excreted into breast
milk. Infant risk
cannot be ruled out.
Comments
Because of
potential for
serious effects in
nursing infants, a
decision should be
made to
discontinue drug
or discontinue
nursing.
6
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Latanoprost
(Xalatan®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk.
Bimatoprost
(Lumigan®,
Latisse®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Use during
pregnancy only if
potential benefit
outweighs
potential fetal risk.
Travoprost
(Travatan®)
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Travoprost may
interfere with
maintenance of
pregnancy, so is
not recommended
for use during
pregnancy or by
women attempting
to become
pregnant.
Drug
Tafluprost
(Zioptan®)
Prescribing for Pregnant or Lactating Women
Drug
Breastfeeding
Information
Comments
Aspirin
D
Studies have
indicated a risk to
the fetus.
The AAP states
that aspirin should
be given with
caution during
lactation.
Probably safest to
avoid use during
pregnancy or
lactation.
Acetaminophen
B
Drug crosses the
placenta,
considered safe
for use at
therapeutic doses
for short periods
of time.
Drug known to
cross into human
breast milk, but
AAP states that it
is compatible with
breastfeeding.
Ibuprofen
B early, D later
Studies have
indicated a risk to
the fetus.
The AAP states
that the drug is
compatible with
breastfeeding.
Drug
Naproxen
Codeine
Hydrocodone
Safer to avoid
during pregnancy.
Prescribing for Pregnant or Lactating Women
Acyclovir
(Zovirax®)
Breastfeeding
Information
Comments
B
Drug easily
crosses the
placenta.
AAP lists the drug as
being compatible
with breastfeeding.
Most human
pregnancy
experience with this
drug compared to
valacyclovir or
famciclovir.
Appears to be
compatible with
breastfeeding.
Prodrug of acyclovir
B
Famciclovir
(Famvir®)
B
Transmission to
fetus assumed due
to low MW of drug.
No lactation studies
have confirmed
safety, use during
breastfeeding is not
recommended.
Trifluridine
(Viroptic®)
C
Use only if
potential benefit
justifies potential
fetal risk
No available reports
relating to
breastfeeding.
C
Not known if drug
is excreted into
breast milk. Infant
risk cannot be
ruled out.
Comments
Pregnancy
Category
Breastfeeding
Information
B early, D later
Studies have
indicated a risk to
the fetus.
Comments
The AAP states
that the drug is
compatible with
breastfeeding.
C
The AAP states
that the drug is
compatible with
breastfeeding, but
caution still
needed.
Caution in
pregnancy and
during lactation if
long-term or high
doses used;
particularly at
term.
Hydrocodonecontaining
analgesics can be
Category C or D
depending on
prolonged use or
high doses near
term.
Available evidence
lacking to confirm
safety while
breastfeeding.
Use during
lactation only if
potential benefit
outweighs
potential risk to
infant.
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Valacyclovir
(Valtrex®)
Breastfeeding
Information
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Drug
Pregnancy
Category
Drug
Natamycin
(Natacyn®)
Pregnancy
Category
C
Unknown if
the drug
crosses the
placenta, but
topically
applied drug
known to
cross into
systemic
circulation in
low amounts.
Breastfeeding
Information
Not known if drug is
excreted into breast
milk. Infant risk
cannot be ruled out.
Comments
The manufacturer
recommends that
the drug only be
prescribed for use in
pregnant women
when clearly needed
and the potential
benefits are
determined to justify
potential risk to the
fetus.
Not recommended
during lactation
unless potential
benefits justify
potential risks.
7
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding Information
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Amoxicillin
(Amoxil®)
B
AAP classifies the drug as
being compatible with
breastfeeding.
Effects in
breastfed infant
are possible1.
Comments
Clindamycin
(Cleocin®)
Drug
B
AAP classifies the drug
as being compatible
with breastfeeding.
Effects in breastfed
infant are possible1.
Amoxicillin/
Clavulanate
(Augmentin®)
B
Effects on infant unknown.
Effects in
breastfed infant
are possible1.
Bacitracin
C
No information on
ophthalmic use.
Ampicillin
(Principen®)
B
AAP classifies the drug as
being compatible with
breastfeeding.
Effects in
breastfed infant
are possible1.
Penicillin VK
B
AAP classifies the drug as
being compatible with
breastfeeding.
Effects in
breastfed infant
are possible1.
Dicloxacillin
(Dynapen®)
B
Probably excreted into
breast milk in low
concentrations, usually
considered compatible with
breastfeeding.
Effects in
breastfed infant
are possible1.
Sulfonamides
1
Drugs in
this group
have a
rating of C.
SMX/TMP
also has a
C rating.
Risks not thought to be
high for healthy infants,
but can be problematic
for infants with health
problems or
prematurity. SMX/TMP
may be compatible with
breastfeeding in a
healthy infant.
Drugs known to
cross the placenta,
particular risks exist
in the third trimester
as neonate could
develop jaundice,
kernicterus, and
hemolytic anemia.
Altered GI flora, inducing allergy/sensitivity, alteration of C & S results
Prescribing for Pregnant or Lactating Women
Drug
Prescribing for Pregnant or Lactating Women
Pregnancy
Category
Breastfeeding
Information
Comments
Cefadroxil
(Duricef®)
B
AAP classifies the drug
as being compatible
with breastfeeding.
Effects in breastfed
infant are possible1.
Cefprozil (Cefzil®)
B
AAP classifies the drug
as being compatible
with breastfeeding.
Effects in breastfed
infant are possible1.
Cefuroxime
(Zinacef®,
Ceftin®)
B
Effects in breastfed
infant are possible1.
Cephalexin
(Keflex®)
B
Effects in breastfed
infant are possible1.
All oral fluoroquinolones are Category C
Drug
Pregnancy
Category
Breastfeeding Information
Comments
Besifloxacin
(Besivance®)
C
Unknown if drug is
excreted into breast milk
Infant risk during
lactation cannot be
ruled out.
Ciprofloxacin
(Ciloxan®)
C
AAP classifies drug as
being compatible with
breastfeeding
Effects in breastfed
infant are possible1.
Gatifloxacin
(Zymaxid®)
C
Excretion into breast milk Effects of exposure
not confirmed, but likely.
to breastfed infant
Caution recommended.
unknown.
Levofloxacin
(Iquix®,
Quixin®)
C
Known to be excreted into Effects of exposure
breast milk.
to breastfed infant
unknown.
A causal relationship with birth defects has not been able to be ruled out with FQs:
study data suggests low risks with some FQs, other data has indicated potential
increased risk during the first trimester for some FQs, and other studies have
concluded that use of these drugs should be avoided if possible during pregnancy.
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Drug
Drug
Pregnancy
Category
Breastfeeding Information
Comments
Moxifloxacin
(Vigamox®,
Moxeza®)
C
Excretion into breast milk Effects of exposure
not confirmed, but likely.
to breastfed infant
Caution recommended.
unknown.
Ofloxacin
(Ocuflox®)
C
AAP classifies drug as
being compatible with
breastfeeding
Pregnancy
Category
Breastfeeding Information
Azithromycin
(Z-Pak®,
Azasite®)
B
Oral form excreted into
breast milk, no data on
topical form.
Clarithromycin
(Biaxin®)
C
Not known but expected
to be excreted into breast
milk. Use caution until
more data is available.
Effects in breastfed
infant are possible1.
Erythromycin
(Excluding
erythromycin
estolate)
B, however
DO NOT
prescribe
estolate
form to
pregnant
patients.
AAP classifies
erythromycins (except
estolate form) to be
compatible with
breastfeeding.
Comments
Effects of exposure
to breastfed infant
unknown, more data
is needed to fully
confirm safety.
Effects in breastfed
infant are possible1.
8
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding Information
Prescribing for Pregnant or Lactating Women
Comments
Gentamicin
(Garamycin®,
Genoptic®)
C
AAP classifies drug as
being compatible with
breastfeeding
Effects in breastfed
infant are possible1.
Tobramycin
(Tobrex®)
B
Is excreted into breast
milk, not recommended
for use during lactation.
Effects in breastfed
infant are possible1.
No consistent data but
minimal excretion into
breast milk is likely.
No data on safety
during lactation.
Neomycin (in
combination
with other antiinfective
agents
Usually C;
check for
individual
products
Prescribing for Pregnant or Lactating Women
Summary Recommendations for Optometrists
• Always treat and prescribe collaboratively with the physician who is
supervising the patient’s pregnancy or breastfeeding period.
- Consult with this physician regarding the eye
condition, and the drug or drugs that are under
consideration for use. Specifically discuss the advisability
of starting the intended course of therapy before
prescribing for the patient, and document the conversation
and conclusions in the medical record.
• Consulting with the patient’s physician and a pharmacist can be helpful in
determining when it is safe to resume nursing an infant if
breastfeeding was temporarily discontinued while completing a
course of therapy.
Prescribing for Pregnant or Lactating Women
Drug
Pregnancy
Category
Breastfeeding Information
Comments
Tetracycline
(Sumycin®)
Is excreted into breast
D
milk.
Many
sources
recommend
avoiding use
entirely
during
pregnancy
Effects in breastfed
infant are possible1.
Doxycycline
(Vibramycin®)
Is excreted into breast
D
milk.
Many
sources
recommend
avoiding use
entirely
during
pregnancy
Effects in breastfed
infant are possible1.
Prescribing for Pregnant or Lactating Women
Summary Recommendations for Optometrists
•Assess whether use of routine office medications (dyes, dilating drugs,
local anesthetics, etc.) are necessary for patients who are pregnant
or breastfeeding an infant. Wherever possible, check with the
patient’s physician and review available current clinical data in
advance.
• Use effective but not excessive anti-infective doses for as short a period of
time as possible, and conduct culture and sensitivity tests when
treating eye infections in patients who are pregnant or lactating.
(C & S results will not only assist in confirming that the prescribed
therapy will be effective, but will also assist in possibly identifying
other efficacious anti-infective agents which may have better
Pregnancy Risk Factor ratings and/or breastfeeding safety profiles.)
Prescribing for Pregnant or Lactating Women
Summary Recommendations for Optometrists
• Recommend use of nasolacrimal occlusion to minimize systemic
absorption when administering topical ophthalmic medications.
• Check or obtain assistance in checking the most recent authoritative
sources of teratogenicity, pregnancy risk, and lactation risk
information prior to prescribing. This information can be provided
by obstetricians, pediatricians, drug information centers, many drug
information databases, and pharmacists.
Optometrists who work collaboratively with the physician who is
supervising the pregnancy or breastfeeding period of a patient
requiring medication therapy, and who follow prudent
recommendations for drug selection and use will provide the
greatest margin of safety for the developing fetus or newborn infant.
• Follow the patient very closely, and stress the importance of keeping all
medical appointments during pregnancy and while nursing an
infant.
9
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Post-activity questions
Post-activity questions
1. Which of the following Pregnancy Risk Categories assigned by the FDA
to a new drug would indicate that the drug should be considered
contraindicated for use during pregnancy?
a.) Category X
b.) Category D
c.) Category C
d.) Category B
a.) using nasolacrimal occlusion after instilling anti-infective eye
drops
b.) looking up Pregnancy Risk Categories on the FDA web site
c.) using antibiotic drops around the clock instead of during waking
hours only
d.) placing lubricating ophthalmic ointment in the eye just before
the anti-infective drops are instilled.
Prescribing for Pregnant or Lactating Women
Prescribing for Pregnant or Lactating Women
Post-activity questions
Post-activity questions
3. Which of the following drugs is generally considered safe to use during
pregnancy and while breast-feeding?
a.) doxycycline
b.) cephalexin
c.) neomycin
d.) clarithromycin
2. Which of the following steps can be recommended and taught to patients
who are pregnant in order to minimize systemic absorption of ophthalmic
anti-infective agents?
4. An optometrist has diagnosed bacterial conjunctivitis in a 28 year-old
woman who is in her first trimester of pregnancy. Which of the following
actions of the optometrist would provide the GREATEST margin of safety
for the developing fetus?
a.) Advise that the patient avoid breast-feeding to avoid transmitting any
residual prescribed antibiotic drug after the infant is born.
b.) Consider use of ophthalmic natamycin only to treat bacterial
infections of the eye in patients who are in the first or second
trimester of pregnancy.
c.) Call the patient’s obstetrician to discuss the advisability of using the
intended antibiotic prior to issuing a prescription for the drug to
the patient.
d.) Use only antibiotic agents that have a Pregnancy Risk Category
rating of C or D in this patient.
10