Journal of Midwifery & Women’s Health www.jmwh.

org
Review

Medication Safety During Pregnancy: Improving

Evidence-Based Practice
CEU
Susan M. Sinclair, PhD, MPH, Richard K. Miller, PhD, Christina Chambers, PhD, MPH,
Elizabeth M Cooper, CNM, EdD

Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse
pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevel-
opmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary
to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incom-
plete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers
need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure.
Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries
are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce
meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable
data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the
limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to
inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy.
J Midwifery Womens Health 2016;61:52–67  c 2016 by the American College of Nurse-Midwives.

Keywords: pregnancy, fetus, drug effects, prescription drugs, teratogenesis, patient safety, evidence-based health care

INTRODUCTION ing pregnancy, reviews additional resources available to health

Nearly 90% of women in the United States have taken one or
more medications during pregnancy and 70% during the first
trimester.1 During the past 30 years, first trimester use of pre-
scription medications increased by more than 60%1 and use
of 4 or more medications during pregnancy tripled during
this time, reaching nearly 30% in 2008.1 The use of medica-
tions that have a suspected or known teratogenic or fetotoxic
risk is common. In a systematic review, Daw et al described
7 studies from Europe, the United States, and Canada report-
ing rates for the use for prescription medications considered
to have potential for harm in pregnancy.2 These rates varied
widely and generally ranged from 1% to 21%.3–9 A study of
prescriptions issued in France found that more than 50% of
pregnant women receive a prescription for a medication that
has a known or suspected fetal risk.5
To guide treatment decisions and counsel clients, health
care providers must to be able to quickly locate the best avail-
able information about the safety of a particular medication
for the pregnant woman and her developing fetus and use this
information to discuss the known risks and benefits with her.
Although heath care providers routinely rely on information
provided by the manufacturer, such as the package insert, this
information is significantly limited regardless of whether it is
based on human evidence or animal studies. Often, adequate
safety data are not available. This article discusses the limi-
tations of the package insert regarding medication safety dur-
Address correspondence to Susan Sinclair, PhD, MPH, Associate Profes-
sor and Epidemiologist, Clinical Research Program, College of Health and
Human Services, University of North Carolina Wilmington, 601 South
College Road, Wilmington, NC 28403-5995. E-mail: sinclairs@uncw.edu
care providers to inform practice, and describes pregnancy
registries in order to communicate the importance of health
care provider participation in pregnancy registries.
BACKGROUND
Approximately 51% of pregnancies were unintended in 2008
in the United States.10 The high prevalence of unintended
pregnancies increases the opportunity for unintentional med-
ication exposure before a woman realizes that she is preg-
nant, at which time she can be well into the first trimester.11,12
Yet, unintentional exposures to medications that are expressly
contraindicated in pregnancy inevitably occur, despite public
awareness of the thalidomide disaster in the 1960s.13 Unfortu-
nately, even medications requiring informed consent from the
pregnant woman and monitoring in specific pregnancy pre-
vention programs such as iPLEDGE for isotretinoin Accutane
(Roche Pharmaceuticals, Nutley NJ) and S.T.E.P.S. for thalido-
mide can be inadvertently prescribed during pregnancy.14,15
Intentional medication use during pregnancy occurs for
a variety of reasons. Women may take medications for preex-
isting conditions requiring treatment during pregnancy (eg,
epilepsy, asthma, hypertension) or acute conditions that de-
velop during pregnancy (eg, gestational diabetes, upper res-
piratory infections, migraines). Women can also intentionally
take medications during pregnancy to protect the health of
the fetus, such as antiretroviral treatment to reduce mother-
to-child transmission of HIV.
A survey of 5381 women who gave birth in the United
States between 2006 and 2009 found the most commonly used
prescription medications during pregnancy were progestins

52 1526-9523/09/$36.00 doi:10.1111/jmwh.12358 
c 2016 by the American College of Nurse-Midwives
 ✦ Information about the safety of medications during pregnancy is limited, and reliance on the package insert alone is
inadequate.
✦ In a busy clinical setting, health care providers need quick access to high-quality, reliable information about medication
safety during pregnancy.
✦ Health care providers can contribute client data to pregnancy registries to help build the collective information about
medication safety in pregnancy that is needed.
from oral contraceptives, amoxicillin (Amoxil), progesterone,
albuterol (Proventil), promethazine (Phenergan), and estro-
genic compounds.16 The most commonly used over-the-coun
ter medication components reported were acetaminophen
(Tylenol), ibuprofen (Advil), docusate (Dulcolax), pseu-
doephedrine (Sudafed), aspirin, and naproxen (Aleve).
Included in this survey was an expert review panel that evalu-
ated safety data for the 54 most commonly used medications.
Only 2 were determined to have sufficient evidence to assess
teratogenic risk.16
The Drug Development Process
The vast majority of newly approved medications lack ade-
quate human pregnancy data to determine teratogenic risk.
In a study of 172 new medications approved by the Food and
Drug Administration (FDA) from 2000 to 2010, Adam et al17
estimated that the teratogenic risk in human pregnancy was
undetermined for 168 (97.7%) of the new medications. For
126 (73.3%) of the new medications, no data were available
regarding safety in pregnancy.
Pregnant women are typically excluded from clinical trials
for new drug development. Therefore, most medications com-
monly used in pregnancy are lacking sufficient data to char-
acterize human fetal risk,16,18 which can explain in part why
so few new medications designed specifically to treat preg-
nancy complications have been developed or approved.18 In-
frequent reports of pregnancies that inadvertently occurred
during clinical trials provide some information but are usually
too few in number to draw conclusions.19 Biopharmaceutical
companies and regulators rely largely on animal studies, with
extrapolation to humans, when developing the drug’s package
insert. More data in the form of human pregnancy exposures
and outcomes are needed to characterize risks and benefits.
Pregnancy registries and similar noninterventional, observa-
tional studies are among the tools available to collect more
data about medication safety during pregnancy.
Package Insert
In a busy clinical setting, health care providers need to have
quick access to high-quality, reliable information about
medication safety during pregnancy, and many rely upon the
Physician’s Desk Reference, which houses the package insert
(also referred to as the product prescribing information)
provided by the manufacturer.20 In the United States, every
prescription medication is required to have FDA-approved
prescribing information, which in the current form is much
Journal of Midwifery & Women’s Health r www.jmwh.org
more a legal document on behalf of the manufacturer rather
than a useful clinical tool. Although the prescribing informa-
tion is updated regularly, it generally does not contain all of
the information available about the safety of the product, nor
does it routinely include results of studies found in the peer-
reviewed scientific literature.
Food and Drug Administration Pregnancy Categories
Within the package insert, is the assigned FDA Pregnancy
Category for each medication. Health care providers routinely
rely upon these categories as a simple, convenient measure
of medication risk during pregnancy; however, the categori-
cal designations are not as evidence-based or clearly defined
as one would hope. For example, one of 5 FDA pregnancy
categories (A, B, C, D, and X) are assigned by the manufac-
turer and approved by the FDA at the time of drug approval
(Table 1).21 The alphabetical order of those categories sug-
gest that medication safety during pregnancy is progressively
worse from A to X; however, a careful review of the defi-
nitions reveals that this assumption is incorrect. Categories
C, D, and X are structured differently from A and B; these
categories weigh risk against benefit and the quantity and
quality of the relevant data and are not progressively riskier
(Table 1).21,22 FDA Category X designation does not neces-
sarily mean the drug is a known teratogen; rather it increases
the weight of the risk in the balance of risk relative to the ben-
efit. Another limitation of this system is that the pregnancy
categories do not always distinguish between risks based on
human data versus risks based on animal data or between dif-
ferences in frequency, severity, type of developmental toxici-
ties, and risks that are limited to specific gestational windows
of exposure. Reliance on the pregnancy categories can result
in poorly informed clinical decision making and could lead
to unnecessary induced abortion for potential embryonic or
fetal harm based on fear of developmental abnormalities that
are not likely to be present.23–25
In 2014, a new regulation was approved in the United
States that eliminates the 5 FDA pregnancy categories.26 The
intent of the new rule is to establish a consistent format for
providing information about the effects of a drug in preg-
nancy and lactation and to make the content more compre-
hensive, current, and useful for decision making by women
and their health care providers.26 Implementation of this
regulation was scheduled to begin in June of 2015. Newly
submitted products will require the new label format upon
submission, and the new format will be phased in over a 5-year
period for all pending submissions and for existing products
53
 Table 1. Food and Drug Administration Pregnancy Categories21
Pregnancy Category A
Pregnancy Category B
Pregnancy Category C
Pregnancy Category D
Pregnancy Category X
Controlled studies show no risk to pregnancy. Adequate, well-controlled studies in pregnant women failed to
demonstrate risk to the fetus.
No evidence of risk in humans. Applies if animal studies show increased risk, but human studies do not; or, if
adequate human studies have not been conducted, animal findings are negative.
Risk cannot be ruled out: Human studies are lacking in availability, and animal studies are either positive for
fetal risk or lacking. In some situations, potential benefits may justify the potential risk.
Positive evidence of risk: Investigational or postmarketing data show risk to the fetus. In some situations,
potential benefits may outweigh the potential risk.
Drug is contraindicated in pregnancy: Studies in animals or humans, or investigational or postmarketing
reports, have shown fetal risk, which clearly outweighs any possible benefit to the patient.

Source: U.S. DHHS. Food and Drug Administration (FDA). Code of Federal Regulations, 21CRF201.57.21

previously approved after June 30, 2001.26 The FDA has issued
draft guidance for industry, which provides additional details
about what is expected in the new label; this document is open
for public comment.27
PREGNANCY MEDICATION INFORMATION FROM
ORGANIZATIONS AND DATABASES
To improve access to safety information, other organizations
have compiled and summarized available data, including
results from pregnancy registries, to serve as a centralized
portal for specific medication safety information. Examples
of sites where providers can quickly find information about
a particular medication exposure during pregnancy are
MotherToBaby,28 REPROTOX,29 TERIS,30 and Treating For
Two.31
MotherToBaby,28 a service of the nonprofit Organiza-
tion of Teratology Information Specialists, provides evidence-
based information to women, health care providers, and the
general public about medications and other exposures during
pregnancy and breastfeeding. MotherToBaby provides online
fact sheets, available in English and Spanish, for individual
medications and other exposures. In addition, MotherToBaby
has a toll-free number (866-626-6847), which can be called for
expert consultation. Services are free of charge. For more in-
formation, visit www.mothertobaby.org.
REPROTOX29 is an online information system contain-
ing summaries on the effects of medications, chemicals, in-
fections, and physical agents on pregnancy, reproduction, and
development. The REPROTOX system was developed as a re-
source for clinicians, scientists, and government agencies. RE-
PROTOX requires an annual subscription. For more informa-
tion, visit www.reprotox.org.
TERIS is an online database of summaries of agents and is
used by health care providers to evaluate the risks of possible
teratogenic exposures in pregnant women. TERIS agent sum-
maries contain a thorough review of published clinical and
experimental literature and includes a risk assessment devel-
oped by an advisory board comprised of nationally recognized
authorities in clinical teratology. The database is searched by
using either generic names or domestic or foreign proprietary
names. An updated, automated version of Shepard’s Catalog
of Teratogenic Agents 32 is distributed with TERIS. A sub-
scription is required to access this service. For more informa-
tion, visit http://depts.washington.edu/terisweb/teris/.
Treating for Two: Safer Medication Use in Pregnancy
Initiative31 is an initiative developed by the Centers for Dis-
ease Control and Prevention in partnership with the FDA
and others to improve the quality and availability of infor-
mation that can be used to inform clinical decision mak-
ing for pregnant women, women who could become preg-
nant, and health care providers. Treating for Two focuses
on expanding research about medication safety during preg-
nancy; evaluating evidence through an expert review process
to compare available treatment options for common health
conditions and to identify the safer option(s) for disease
management during pregnancy; and educating women and
health care providers with expert summaries of medication
safety and disease management. For more information, visit
http://www.cdc.gov/pregnancy/meds/treatingfortwo/.31
In the United States and Canada, teratology information
is provided to health care providers and the general pub-
lic through a network of professional organizations that are
part of the Organization of Teratology Information Specialists
(OTIS).28 In Europe, several organizations that provide ter-
atogen information services comprise the membership of the
European Network of Teratology Information Services.33 The
primary mission of these organizations is to provide counsel-
ing regarding the safety of a medication or other agent dur-
ing pregnancy to women and heath care providers. In addition
to providing this service, these organizations have attempted
to expand available evidence by also conducting pregnancy
registries.
PREGNANCY REGISTRIES
In contrast to the package insert and its reliance on preap-
proval studies, pregnancy registries are observational studies
that accrue postmarketing data about the safety of specific
medications or conditions during pregnancy. Pregnancy reg-
istries are designed to assess the safety of human pregnancy
exposures for specific approved medications and vaccines,34
and often the impact of disease on pregnancy and pregnancy
outcomes is evaluated.
Pregnancy registries are not analogous with disease reg-
istries and other types of registries designed for surveil-
lance purposes (eg, cancer registries). Pregnancy registries are

54 Volume 61, No. 1, January/February 2016

observational studies that collect data longitudinally, from
early in pregnancy into infancy, and compare outcomes with
an internal or external control group.34,35 Typically, research
hypotheses are specified a priori and inferential statistics are
used to evaluate the stated objectives. Pregnancy registries are
generally classified as disease registries that involve pregnant
women with the disease of interest or product registries that
focus on specific product or class of products.35 Pregnancy
registries are also referred to as pregnancy exposure registries,
given the focus on product exposure during pregnancy. Preg-
nancy registries are often implemented by the manufacturer
and can be required by regulatory agencies as a condition of
medication approval or initiated voluntarily after approval.
Academia, nonprofit groups, government agencies, and or-
ganizations that provide teratogen information services also
conduct pregnancy registries.
The primary objective of most pregnancy registries is to
monitor exposed women for major developmental effects or
birth defects associated with pregnancy exposures.34 How-
ever, since these studies are designed to recruit women on
the basis of exposure to a drug or disease of interest and
are conducted prospectively (ie, enrollment occurs before
the outcome of pregnancy is known), a range of adverse
pregnancy outcomes—including fetal growth abnormalities,
spontaneous abortion or stillbirth, preterm birth, and other
maternal or neonatal complications—can be studied.
The registries included in Table 224,25,36-42 serve as exam-
ples to highlight some of the most common similarities and
differences. Included in this set of examples are registries that
are conducted by the industry or by universities or terato-
gen information services organizations with or without indus-
try support. Many registries rely on population-based birth
defects rates as an external comparison group; however, to
strengthen the design, several registries have enrolled one or
more internal comparison groups. Data collection methods
vary across registries in frequency of contact, types of re-
porters (woman, prescriber, maternity care provider, pediatric
care provider), use of physical examinations, and review of
medical records.
Most pregnancy registries rely on voluntary reporting by
health care providers who have eligible women in their prac-
tice. The pregnancy exposure under study may occur infre-
quently; therefore, to optimize enrollment, most pregnancy
registries are open to anyone in the target population who
meets the entry criteria. Reporters are not required to be
an investigator or otherwise affiliated with the registry. The
FDA encourages pregnancy registry sponsors to post a reg-
istry description and contact information on the FDA Web
site to raise awareness of the registry and encourage enroll-
ment. Currently, 64 pregnancy registries are listed on the FDA
Web site, and this list is updated frequently.42 Table 3 contains
a listing of pregnancy registries found from a review of the
FDA’s Web site42 and through Internet searches; this listing
has been adapted for clinical use and organized by therapeu-
tic area.
Pregnancy registries are designed so that participation is
easy with minimal time and resource involvement. Women
and/or their health care providers submit data to the registry
at various intervals. Data collection is accomplished electron-
ically, on paper, or by phone; and the registry’s coordinating
Journal of Midwifery & Women’s Health r www.jmwh.org
center facilitates data collection and manages the registry. In
general, study-specific office visits are not required. A typi-
cal registry collects data on a pregnant woman early in preg-
nancy, midpregnancy, and just after pregnancy has ended. If
the pregnancy outcome is a live born neonate, he or she may
be followed for a period of months to years, depending on
the suspected potential toxicities and registry objectives. Preg-
nancy registries may collect outcome information for many
years after birth, which allows for the evaluation of neurode-
velopmental endpoints to help identify or rule out behavioral
teratogens. Variations in data collection methods are seen in
the examples provided in Table 2.
Bias can be introduced if prenatal testing provides evi-
dence of abnormalities prior to enrollment. Therefore, enroll-
ment early in pregnancy is encouraged because it reduces the
likelihood that prenatal testing has already occurred. For this
reason, some registries exclude women with abnormal prena-
tal tests at the time of enrollment. The prospective orientation
reduces the potential for recall bias that may be inherent in
some case-control studies. In case-control studies, women are
asked about pregnancy exposures to medications after birth
when their recall of specific exposures may be influenced
by the fact that they did or did not have a poor pregnancy
outcome.
Registries may enroll an internal control group (ie, a group
of pregnant women who have not had the medication ex-
posure of interest) or may compare findings to an external
comparator, such as published rates from population-based
surveillance systems or unexposed cohorts from other stud-
ies. In the absence of enrolling an internal comparison group,
it is critical to understand the limitations and comparability of
the external comparison group. Women who take a particu-
lar medication may differ from women in the general popula-
tion in characteristics that also influence their risk for adverse
pregnancy outcomes. For example, women who take a med-
ication for hypercholesterolemia or diabetes may be signifi-
cantly more likely to be obese than the women in the general
population, a characteristic that independently poses an in-
creased risk for specific congenital malformations. A registry
with an internal comparison group of unexposed women, for
whom maternal body mass index (BMI) data are collected, al-
lows the registry to account for the contribution of BMI to the
adverse outcome43 and therefore may help to more accurately
and validly identify or rule out complications that are due to
the medication itself. Similarly, the underlying maternal dis-
ease for which the medication is prescribed may contribute to
adverse pregnancy outcomes; for example, maternal asthma
itself is associated with an increased risk of congenital malfor-
mations, perinatal mortality, and neonatal hospitalization.44
Therefore, a comparison group of pregnant women who have
the same underlying disease as the exposed group but have not
taken the medication of interest can help sort out the potential
problems associated with the drug as opposed to those asso-
ciated with the disease. Table 2 provides examples of registries
that use internal and external comparison groups.
Registries are expected to disseminate their findings to
inform women and providers.34 Some registries embrace
this aspect, providing interim and final reports of their re-
sults online36,45 or by request, and publish frequently in the
scientific literature, as data accumulate. For example, the
55
 Table 2. Selected Examples of Pregnancy Registries
Registry Data Collection/ Accomplishments and Unique
Description Objectives Population Methods Features
Antiretroviral Study pregnant women Pregnant women with 2 sets of data forms Has enrolled nearly 18,000
Pregnancy Registry36 exposed to any of 38 ARV exposure during submitted women since initiated in
Multiple product different ARVs, (all pregnancy anonymously by 1989.
registry marketed ARVs in woman’s HCP: early One of the longest running
Industry-based United States) in pregnancy and pregnancy registries.
Cosponsored by shortly after Uses population-based data as
manufacturers of 38 pregnancy control group.
antiretrovirals (ARV)

National Examine risks associated Pregnant women with a 1-page questionnaire Enrolled ⬎ 2200 transplant
Transplantation with numerous and history of solid organ about posttransplant recipients (3300 pregnancies)
Pregnancy evolving medical transplantation or pregnancies, since 1991.
Registry37,38 products and whose pregnancy is completed by Includes male exposures.
Disease registry procedures related to fathered by male transplant Contributed to identification of
University-based transplantation transplant recipients coordinator, HCP, or the association between
transplant recipient mycophenolate mofetil
(CellCept) and increased
incidences of spontaneous
abortions and congenital
malformations, resulted in
change from Pregnancy
Category C to D in 2007.

North American Determine frequency of Pregnant women with or 3 brief telephone More than 9,300 women have
Antiepileptic Drug major malformations without AED interviews with been enrolled since this
(AED) Pregnancy in infants exposed to exposure during woman at enrollment, registry was initiated in 1997.
39 AED drugs during pregnancy 7 months’ gestation,
Registry Includes both internal and
Multiple product pregnancy and 8 to 12 weeks external control groups; an
registry after expected date of internal, unexposed control
University-based birth group is a major strength and
Cosponsored by several infrequently seen in
AED manufacturers industry-sponsored registries.
2125 women enrolled since
1999.

OTIS Autoimmune Monitor planned and Pregnant women with
Diseases in Pregnancy unplanned
Study40,41 pregnancies exposed
Multiple product to certain
registry medications, to
University- and evaluate the possible
teratogen information teratogenic effect, and
services-based to follow live-born
neanates for one year
after birth
Maternal telephone Found no significant difference
RA, psoriasis, interviews: 3 during in major defects and no
psoriatic arthritis, pregnancy; at pattern of minor defects
Crohn’s disease, outcome; 1 year infant among 64 women with RA
ankylosing follow-up exposed to leflunomide
spondylitis, and Outcome confirmed by (Arava) during pregnancy
multiple sclerosis medical records; compared to 108 unexposed
with or without includes specialized, women with RA and 78
medication exposure blinded infant physical unexposed women without
for these indications examination by RA.
dysmorphologists/ Although based on small
geneticists for major numbers, provides first
and minor defects

(Continued)

56 Volume 61, No. 1, January/February 2016

 Table 2. Selected Examples of Pregnancy Registries
Registry Data Collection/ Accomplishments and Unique
Description Objectives Population Methods Features
human study data and some
reassurance regarding
inadvertent leflunomide
exposure in early pregnancy.
Use of 2 comparison groups
and blinded infant physical
examination are major
strengths of this study.

Ribavirin Pregnancy
Registry24,25
Multiple product
registry
Industry-based
Cosponsored by all 7
manufacturers of
ribavirin in the United
States
Monitor pregnancy
exposures to ribavirin
and evaluate the
potential human
teratogenicity of
prenatal exposure
Pregnant women with 5 data collection time
ribavirin exposure
during pregnancy or
6-month period
before pregnancy; or
if similarly exposed
through male sexual
partner taking
ribavirin
Enrolled 263 pregnancies since
points: early 2004.
pregnancy; Category X product.
midpregnancy; end of Includes male exposures.
pregnancy; infant 6 Long exposure window (6
and 12 months, from months prior to conception)
prescriber, maternity due to the long half-life of
HCP, pediatric HCP ribavirin (Copegus, Rebetol)
Uses population-based data as
control group.

Abbreviations: AED, antiepileptic drug; ARV, antiretroviral; HCP, health care provider; RA, rheumatoid arthritis.

Antiretroviral Pregnancy Registry, which has been operating
since 1989, uploads their interim report36 twice yearly provid-
ing the most up-to-date results from the registry to health care
providers. Most registries publish their data in the scientific
literature and many publish interim findings, although unfor-
tunately some wait until the study has ended, which decreases
the clinical usefulness of the data.
Commonly, registries conducted by organizations pro-
viding teratogen information services obtain enrollees from
individuals who call the organization seeking counseling re-
garding the safety of a medication or other agent to which the
woman has already been exposed or might be exposed. For se-
lected target exposures, exposed and unexposed comparison
women are enrolled in a registry; the unexposed women form
the internal control group. The OTIS Autoimmune Diseases
in Pregnancy Study40,41 is an example of a registry based in an
organization whose primary function is to deliver teratogen
information services (Table 2).
Pregnancy registries are often slow to enroll, and results
may not be available for years after the product enters the mar-
ket. The pace of enrollment may be related to a low prevalence
of eligible women (rare exposures during pregnancy) or may
reflect a lack of awareness about the registry, including meth-
ods for reporting, or both. This lack of information inhibits
the ability of the health care provider to provide evidence-
based care to pregnant women.
There is much room for improvement in the conduct of
pregnancy registries. In 2009, the OTIS Research Commit-
tee published a position article calling for better data from
pregnancy registries.47 The committee called for more spe-
cific information on the timing and dose of drug exposures
from pregnancy registries to improve the estimation of risk
for developmental toxicity, thereby increasing the usefulness
of the data in assessing outcomes such as growth alteration,
structural anomalies, functional/neurobehavioral deficits, or
death.
CLINICAL IMPLICATIONS
A health care provider may make a connection between a
number of women with a specific problem and their com-
mon prenatal medication exposure. For example, Herbst48
first noted the link between in utero exposure to diethyl-
stilbestrol (DES) and clear cell adenocarcinoma in females.
Due in part to Herbst’s observations, DES was withdrawn
from the market, and health care providers and women are
now well aware of this association. An individual health care
provider may never encounter a phenomenon such as was
seen by Herbst,48 particularly if the exposures are rare, the
strength of the exposure-disease relationship is weak, or the
outcome is less striking. However, all health care providers
are given the opportunity to study these issues prospectively
by participating in pregnancy registries. This research activ-
ity is not limited to the midwife, nurse practitioner, pedia-
trician, obstetrician-gynecologist, oncologist, or pathologist;
every pregnant woman and health care provider possesses po-
tentially valuable data needed by pregnancy registries.
There are several actions that may be taken by health
care providers to address the overall lack of information
about medication safety during pregnancy. Keeping the

Journal of Midwifery & Women’s Health r www.jmwh.org 57

 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Antiinfective HIV/AIDS All antiretroviral Antiretroviral Pregnancy Registry/INC Research, LLC
medications marketed Phone: 800-258-4263
in the United States Web site: http://www.apregistry.com/
for HIV/AIDS
Antiinfective Hepatitis C Ribavirin (includes all Ribavirin Pregnancy Registry/INC Research, LLC
brand and generic Phone: 800-593-2214
products) E-mail: pregnancyregistries@incresearch.com
Web site: www.ribavirinpregnancyregistry.com
Autoimmune Rheumatoid arthritis Tocilizumab (Actemra) OTIS Autoimmune Diseases Study
Phone: 877-311-8972
http://www.pregnancystudies.org/ongoing-pregnancy-
studies/autoimmune-studies/autoimmune-disease-
treatments-pregnancy/
Autoimmune Rheumatoid arthritis Leflunomide (Arava) Leflunomide Pregnancy Registry/OTIS/MotherToBaby
1-877-311-8972
Autoimmune Multiple sclerosis Teriflunomide (Arava) OTIS Autoimmune Diseases Study
Phone: 877-311-8972
http://www.pregnancystudies.org/ongoing-pregnancy-
studies/autoimmune-studies/autoimmune-disease-
treatments-pregnancy/
Autoimmune Systemic lupus Belimumab (Benlysta) Benlysta Pregnancy Registry/GlaxoSmithKline
erythematosus (SLE) Phone: 877-681-6296
Web site: http://pregnancyregistry.gsk.com/belimumab.html
Autoimmune Rheumatoid arthritis Certolizumab OTIS Autoimmune Diseases
Psoriatic arthritis pegol (Cimzia) Phone: 877-311-8972
Ankylosing spondylitis Web site: http://www.pregnancystudies.org/ongoing-
Psoriasis pregnancy-studies/autoimmune-studies/autoimmune-
Crohn’s disease disease-treatments-pregnancy/
Autoimmune Rheumatoid arthritis Etanercept (Enbrel) OTIS Autoimmune Diseases
Psoriatic arthritis Phone: 877-311-8972
Ankylosing spondylitis Web site: http://www.pregnancystudies.org/ongoing-
Psoriasis pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/
Autoimmune Multiple sclerosis Fingolimod (Gilenya) The Gilenya Pregnancy Registry/Novartis Pharmaceuticals
Phone: 877-598-7237
Web site: http://www.gilenyapregnancyregistry.com
Autoimmune Rheumatoid arthritis Adalimumab (Humira) OTIS Autoimmune Diseases
Psoriatic arthritis Phone: 877-311-8972
Ankylosing spondylitis Web site: http://www.pregnancystudies.org/ongoing-
Crohn’s disease pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Autoimmune Psoriasis Cyclosporine USP Neoral Pregnancy Registry for Psoriasis and Rheumatoid
Rheumatoid arthritis (Neoral) Modified Arthritis
Gift of Life Institute
Phone: 215-599-2078
Toll-free: 888-522-5581
E-mail: npr.registry@giftoflifeinstitute.org
Web site: http://www.ntpr.giftoflifeinstitute.org
Autoimmune Severe rheumatoid Abatacept (Orencia) OTIS Autoimmune Diseases
arthritis Phone: 877-311-8972
Web site: http://www.pregnancystudies.org/ongoing-
pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/
Autoimmune Psoriatic arthritis Apremilast (Otezla) OTIS Autoimmune Diseases
Psoriasis Phone: 877-311-8972
Web site: http://www.pregnancystudies.org/ongoing-
pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/
Autoimmune Psoriatic arthritis Ustekinumab (Stelara) OTIS Autoimmune Diseases
Psoriasis Phone: 877-311-8972
Web site: http://www.pregnancystudies.org/ongoing-
pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/
Autoimmune Multiple sclerosis Dimethyl fumarate Tecfidera Pregnancy Exposure Registry
(Tecfidera) Phone: 866-810-1462
Web site: https://www.tecfiderapregnancyregistry.com/
Autoimmune Rheumatoid arthritis Tofacitinib (Xeljanz) OTIS Autoimmune Diseases
Phone: 877-311-8972
Web site: http://www.pregnancystudies.org/ongoing-
pregnancy-studies/autoimmune-studies/autoimmune-
disease-treatments-pregnancy/
Dermatologic Psoriasis Cyclosporine USP Neoral Pregnancy Registry for Psoriasis and Rheumatoid
Rheumatoid arthritis (Neoral) Arthritis
Gift of Life Institute
Phone: 888-522-5581
E-mail: npr.registry@giftoflifeinstitute.org
Web site: http://www.ntpr.giftoflifeinstitute.org
Dermatologic Antibacterial for skin Telavancin (Vibativ) Vibativ Pregnancy Registry
infection Phone: 888-658-4228
Web site: www.clinicaltrials.gov
Dermatology Psoriasis Acitretin T.A.P.P. (Take Action to Prevent Pregnancy)
Pregnancy Monitoring Program for Acitretin
Phone: 855-850-2138
Web site: http://www.tevagenerics.com/acitretin

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Endocrine/ Type 2 diabetes Exenatide (Bydureon) Exenatide Pregnancy Registry/INC Research LLC
metabolic Phone: 800-633-9081
Web site: http://www.exenatidepregnancyregistry.com/
Endocrine/ Type 2 diabetes Sitagliptin phosphate Merck Pregnancy Registry Program
metabolic plus metformin Phone: 800-986-8999
hydrochloride Web site: www.merckpregnancyregistries.com/januvia.html
(Janumet)
Endocrine/ Type 2 diabetes Sitagliptin phosphate Merck Pregnancy Registry Program
metabolic (Januvia) Phone: 800-986-8999
Web site: www.merckpregnancyregistries.com/januvia.html
Genetic MPSI Laronidase MPSI Registry/Genzyme Corporation
Hurler’s syndrome (Aldurazyme) Phone: 617-591-5500
Scheie’s syndrome E-mail: help@mpsiregistry.com
Hurler-Scheie syndrome Web site: http://www.lsdregistry.net/mpsiregistry
Genetic Fabry disease Agalsidase beta Fabry Registry/Genzyme Corporation
(Fabrazyme) Phone: 617-591-5500
E-mail: help@FabryRegistry.com
Web site: https://www.registrynxt.com/fabry/Pages/Home.aspx
Genetic Pompe disease Alglucosidase alfa Pompe Disease Registry/Genzyme Corporation
(GAA deficiency) (Myozyme) Phone: 617-591-5500
E-mail: help@PompeRegistry.com
Web site:
https://www.registrynxt.com/Pompe/Pages/Home.aspx
Genetic Maroteaux-Lamy Galsulfase (Nagazyme) MPS VI Clinical Surveillance Program/BioMarin
syndrome also known Pharmaceutical
as polydystrophic Phone: 415-506-6849
dwarfism or MPS VI Web site:
https://clinicaltrials.gov/ct/show/NCT00214773?order=2
Hematologic ITP Romiplostim (Nplate) Nplate Pregnancy Exposure Registry/Amgen
Phone: 800-772-6436
Web site: http://www.nplate.com/patient/how-nplate-may-
help/taking-nplate.html
Hematologic ITP Eltrombopag Promacta Pregnancy Registry/GlaxoSmithKline
(Promacta) Phone: 877-379-3718
Web site: https://clinicaltrials.gov/ct2/show/NCT01064336
Musculoskeletal Osteoporosis Penosumab (Prolia) Amgen’s Pregnancy Surveillance Program
Phone: 800-772-6436
Neurologic Epilepsy Antiepileptic drugs AED Pregnancy Registry/Massachusetts General Hospital
Phone: 888-233-2334
Web site: http://www.massgeneral.org/aed/
Neurologic Epilepsy Eslicarbazepine acetate AED Pregnancy Registry/Massachusetts General Hospital
(Aptiom) Phone: 888-233-2334
Web site: http:www.massgeneral.org/aed/

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Neurologic Partial onset seizures Levetiracetam (Keppra) UCB AED Pregnancy Registry/INC Research, LLC
(No longer accepting Phone: 888-537-7734
new registrations) Web site:
http://www.clinicaltrials.gov/CT2/show/NCT00345475
Neurologic Epilepsy, neuropathic Pregabalin (Lyrica) AED Pregnancy Registry/Massachusetts General Hospital
pain Phone: 888-233-2334
Web site: www.massgeneral.org/aed/
Neurologic Migraine headaches Rizatriptan (Maxalt) Merck Pregnancy Registry Program
Phone: 800-986-8999
Web site: www.merckpregnancyregistries.com/maxalt.html
Neurologic Excessive sleepiness Armodafinil (Nuvigil) Nuvigil Pregnancy Registry/Teva Pharmaceuticals
associated with: Phone: 866-404-4106
obstructive sleep Web site: http://www.nuvigilpregnancyregistry.com/
apnea, hypopnea
syndrome, narcolepsy,
shift work sleep
disorder
Neurologic Excessive sleepiness Modafinil (Provigil) Provigil Pregnancy Registry/Teva Pharmaceuticals
associated with: Phone: 866-404-4106
obstructive sleep Web site: http://provigilpregnancyregistry.com/
apnea, hypopnea
syndrome, narcolepsy,
shift work sleep
disorder
Neurologic Fibromyalgia Milnacipran (Savella) Savella Pregnancy Registry/INC Research
Phone: 877-643-3010
E-mail: pregnancyregistries@incresearch.com
Web site: www.savellapregnancyregistry.com
Oncology Cancer and childbirth Cancer and cancer Cooper Health
registry treatments Phone: 877-635-4499
Web site: www.cooperhealth.org/departments-
programs/cancer-and-pregnancy
Oncology Breast cancer Ado-trastuzumab MotHER Pregnancy Registry/INC Research, LLC
emtansine (Kadcyla) Phone: 800-690-6720
Web site: http://www.motherpregnancyregistry.com/
Oncology Breast cancer Pertuzumab (Perjeta) MotHER Pregnancy Registry/INC Research, LLC
Phone: 800-690-6720
Web site: http://www.motherpregnancyregistry.com/
Organ transplant Immunosuppressive Mycophenolate Mycophenolate Pregnancy Registry
drug (renal (Cellcept) National Transplantation Pregnancy Registry
transplant) Phone: 800-617-8191
Web site: www.mycophenolatepregnancyregistry.com

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Organ transplant Immunosuppressive Mycophenolate Mycophenolate Pregnancy Registry
drug (renal (Myfortic) National Transplantation Pregnancy Registry
transplant) Phone: 800-617-8191
Web site: www.mycophenolatepregnancyregistry.com
Organ transplant Immunosuppressive Belatacept (Nulojix) National Transplantation Pregnancy Registry
drug (renal Gift of Life Institute
transplant) Phone: 877-955-6877
Web site: http://www.ntpr.giftoflifeinstitute.org/
Organ transplant Transplants Pregnant women who National Transplantation Pregnancy Registry
anti-rejection medicines are transplant Gift of Life Institute
recipients or whose Phone: 877-955-6877
pregnancy is fathered E-Mail: ntpr@giftoflifeinstitute.org
by a transplant Web site: www.ntpr.giftoflifeinstitute.org
recipient
Psychiatric Atypical antipsychotics Aripiprazole (AbilifY) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Atypical antipsychotics CLozapine (Clozaril) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Major depressive Duloxetine HCl Cymbalta Pregnancy Registry/INC Research, LLC
disorder (Cymbalta) Phone: 866-814-6975
generalized anxiety E-mail: pregnancyregistries@incresearch.com
disorder Web site: http://www.cymbaltapregnancyregistry.com/
diabetic peripheral
neuropathic pain
fibromyalgia
Psychiatric Psychiatric conditions Iloperidone (Fanapt) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions Ziprasidone (Geodon) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Psychiatric Psychiatric conditions Paliperidone (Invega) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions Lurasidone (Latuda) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions Risperidone (Risperdal) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions Asenapine (Saphris) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions Quetiapine (Seroquel) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Psychiatric Psychiatric conditions OLanzapine (Zyprexa) National Pregnancy Registry for Atypical Antipsychotics
Center for Women’s Mental Health, Mass. General Hospital
Phone: 866-961-2388
E-mail: registry@womensmentalhealth.org
Web site: www.womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry
Respiratory Asthma Long-acting beta agonist MotherToBaby Pregnancy Studies conducted by OTIS
and short-acting beta Phone: 877-311-8972
agonist products Web site:
http://www.pregnancystudies.org/ongoing-pregnancy-
studies/asthma-study/asthma-treatments-pregnancy/

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Respiratory Asthma Montelukast (Singulair) Merck Pregnancy Registry Program
Phone: 800-986-8999
Web site: www.merckpregnancyregistries.com/singulair.html
Respiratory Asthma Omalizumab (Xolair) EXPECT Xolair Pregnancy Registry
Phone: 866-496-5247 Option 3
Web site: http://www.xolairpregnancyregistry.com/
Vaccine Prevention of seasonal Influenza virus vaccine Seasonal Influenza Vaccine Pregnancy
influenza (Fluarix, Fluarix Registry/GlaxoSmithKline
Quadrivalent) Phone: 888-825-5249
Web site: http://pregnancyregistry.gsk.com/
seasonalInfluenzaVaccines.html
Vaccine Prevention of influenza Influenza vaccine The Flu Vaccine Pregnancy Registry/PPD, Inc.
(Flucelvax) Phone: 877-413-4759
E-mail: NovartisVaccinePregnancyRegistries@ppdi.com
Web site: https://www.ppdi.com/Services/Post-
Approval/Patient-Registries-and-Observational-
Studies/Pregnancy-Registries/Registry-Descriptions
Vaccine Prevention of seasonal Influenza virus vaccine Seasonal Influenza Vaccine Pregnancy Registry
influenza suspension Phone: 888-825-5249
(Flulaval, Flulaval Web site: http://pregnancyregistry.gsk.com/
Quadrivalent) seasonalInfluenzaVaccines.html
Vaccine Prevention of human Human Papillomavirus Merck Gardasil Pregnancy Registry
papillomavirus Quadrivalent (Types Phone: 800-986-8999
6, 11, 16, and 18) Web site: www.merckpregnancyregistries.com/gardasil.html
Vaccine,
Recombinant
(Gardasil)
Vaccine Prevention of meningitis Meningococca Menactra Vaccine Pregnancy Registry
polysaccharide Phone: 800-822-2463
diptheria toxoid
(Menactra)
Vaccine Prevention of meningitis Meningitis vaccine Menveo Pregnancy Exposure Registry
(Menveo) Phone: 877-311-8972
Web site: http://www.pregnancystudies.org/ongoing-
pregnancy-studies/influenza-vaccine-antiviralmedications-
study/
Vaccine Prevention of meningitis Meningitis vaccine Menveo Vaccine Pregnancy Registry
(Menveo) Phone: 877-413 4759
E-mail: NovartisVaccinePregnancyRegistries@ppdi.com
Web site: http://www.ppdi.com/Services/Post-
Approval/Patient-Registries-and-Observational-
Studies/Pregnancy-Registries/Registry-Descriptions.aspx

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 Table 3. Pregnancy Exposure Registries from Internet Searches and the List of Pregnancy Exposure Registries on the FDA Web Site43
Medicine
or Disease
Drug System Medical Condition Registry Focus Registry Contact Information
Vaccine Prevention of hepatitis A Combined hepatitis A Twinrix Pregnancy Registry/GlaxoSmithKline
Prevention of hepatitis B [inactivated] and Phone: 888-825-5249
hepatitis B Web site: http://pregnancyregistry.gsk.com/twinrix.html
[recombinant]
vaccine (Twinrix)
Vaccine Prevention of meningitis Meningitis vaccine MotherToBaby Pregnancy Studies conducted OTIS
(Menveo) Phone: 877-311-8972
Web site: www.pregnancystudies.org/
Vaccine Prevention of measles, Measles, Mumps, The Pregnancy Registry for Varicella Zoster Virus
mumps, rubella and Rubella and Varicella (VZV)-containing Vaccines/Merck & Company, Inc.
chicken pox Virus Vaccine Live Phone: 800-986-8999
(Proquad) Web site: www.merckpregnancyregistries.com/varivax.html
Vaccine Prevention of Varicella Virus Vaccine The Pregnancy Registry for Varicella Zoster Virus
chickenpox Live (Varivax) (VZV)-containing Vaccines/Merck & Company, Inc.
Phone: 800-986-8999
Web site: www.merckpregnancyregistries.com/varivax.html
Vaccine Prevention of herpes Zoster Vaccine Live The Pregnancy Registry for Varicella Zoster Virus
zoster (Zostavax) (VZV)-containing Vaccines/ Merck & Company, Inc.
Phone: 800-986-8999
Web site: www.merckpregnancyregistries.com/varivax.html

Abbreviations: GAA, acid alpha-glucosidase; ITP, idiopathic thrombocytopenic purpura; MPSI, mucopolysaccharidosis type I; MPS VI, mucopolysaccharidosis VI; OTIS,
Organization of Teratology Information Specialists; VAMPSS, Vaccines and Medications in Pregnancy Surveillance Study; VZV, varicella zoster virus.
Source: Internet searches and U.S. DHHS. Food and Drug Administration. Women’s Health Research. List of Pregnancy Exposure Registries.42

list of pregnancy registries42 near the telephone, computer, CONCLUSION

and/or patient medical records (Table 3) will enable rapid
identification of existing registries, preferably during the
woman’s office visit. Assisting the woman with contacting
the registry during her appointment facilitates enrollment
because postponing can lower enrollment rates. Even if the
woman discontinues the medication prior to pregnancy, she
may be eligible to participate in a registry as a member of the
unexposed control group.
Locating an appropriate pregnancy registry can be accom-
plished in several ways, such as referring to Table 3, search-
ing the pregnancy registry listing on the FDA Web site,42
or contacting MotherToBaby.28 MotherToBaby28 is a conve-
nient resource for questions about whether there is a registry
for a drug of concern (www.mothertobaby.org or 866-626-
6847). MotherToBaby provides information about ongoing
pregnancy registries for a particular exposure, in addition to
providing summary information about pregnancy exposures.
In addition, health care providers are encouraged to contact
administrators and/or providers of electronic medical records
to incorporate flags or reminders to facilitate enrollment of
women in the appropriate pregnancy exposure registry if a
drug is electronically prescribed and/or prescribed within the
study protocol-specified window of exposure.
Health care providers are encouraged to evaluate each preg-
nant woman as a potential registry participant if she has been
exposed to one of the medications for which a registry is avail-
able; if she is not exposed, she may be evaluated to determine
eligibility to contribute data as a member of an unexposed
control group. When health care providers enroll pregnant
women in pregnancy registries, they add to the body of
evidence that will eventually be used to inform their practice.
As these studies accumulate data and report findings, this
important information will appear in the scientific literature,
in clinical practice aids such as the MotherToBaby28 online
fact sheets, and eventually, in the product package inserts as
the new labeling regulations are implemented. If health care
providers increasingly participate in reporting to pregnancy
registries, the timeliness of receiving this information will be
greatly improved.
AUTHORS
Susan Sinclair, PhD, MPH, is Associate Professor at the Uni-
versity of North Carolina at Wilmington in the Clinical Re-
search Program. She is also a consultant epidemiologist to
INC Research (Wilmington, NC). She serves as the principal
investigator for the Ribavirin Pregnancy Registry.

Journal of Midwifery & Women’s Health r www.jmwh.org 65

Richard Miller, PhD, is Professor of Obstetrics and Gyne-
cology, Environmental Medicine, and Pathology and Clinical
Laboratory Medicine at the University of Rochester School
of Medicine and Dentistry, New York. He is also Director
of MotherToBaby URMedicine (NY, NJ, PA Teratogen In-
formation Service). He is Past President of the US Teratol-
ogy Society, Chair of the OTIS-ENTIS International Research
Consortium.
Christina Chambers, PhD, MPH, is Professor in the De-
partment of Pediatrics and Family and Preventive Medicine
at the University of California, San Diego (UCSD) School
of Medicine. Dr. Chambers has worked as an epidemiolo-
gist with MotherToBaby CA and the national MotherToB-
aby Organization for the last 16 years. Dr. Chambers is a past
President of the US Teratology Society, past president of the
Organization of Teratology Information Specialists (OTIS),
and leads the OTIS collaborative research center located at
UCSD.
Elizabeth Cooper, CNM, EdD, FACNM, is Professor Emeritus
of Obstetrics and Gynecology at the University of Rochester
School of Medicine and Dentistry, New York. She is the
founder of the University of Rochester Medical Center’s mid-
wifery practice in 1975 and was Director of the Department
of Obstetrics and Gynecology’s Midwifery Division from 1992
to 2013.
CONFLICTS OF INTEREST
Drs. Sinclair and Miller are paid consultants to INC Research
in Wilmington, North Carolina, which manages the Ribavirin
Pregnancy Registry and the Antiretroviral Pregnancy Registry
on behalf of its industry sponsors. Dr. Miller is also a mem-
ber of the Scientific Board of the MotHER Pregnancy Reg-
istry. Drs. Chambers and Cooper have no conflicts of interest
to disclose
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