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. Author manuscript; available in PMC: 2016 Jan 12.
Published in final edited form as: Obstet Gynecol. 2013 Oct;122(4):885–900. doi: 10.1097/AOG.0b013e3182a5fdfd

Table 1.

Summary of Antibiotic Studie

Antibiotic
(# of articles)b 		Safety Pharmacokinetics REPROTOX TERIS
Risk/Data		 FDA
a 		Briggs’
Amoxicillin
(18 articles)		 2 case-control
studies suggest
increased risk of
cleft lip with or
without cleft
palate, based on
small numbers of
exposed cases,
but most studies
suggest no
increased risk		 Limited data:
Dosing
adjustments are
likely necessary to
maintain adequate
levels		 2011: Acceptable for use
during pregnancy		 2008: Therapeutic doses are
unlikely to pose a substantial
risk.
Data are insufficient to state
there is no risk		 B Pregnancy:
compatible
Ampicillin
(34 articles)		 1 Case-
control study
suggested
increased risk of
isolated cleft
palate, based on
small numbers of
exposed cases,
but most studies
suggest no
increased risk		 Limited data:
Dosing adjustments
may be necessary		 2012: Not believed to
increase adverse
outcomes		 2010: Therapeutic doses during
pregnancy are unlikely to pose a
substantial teratogenic risk.
Data are insufficient to say
there is no risk		 B Pregnancy:
compatible
Chloramphenicol
(7 articles)		 No increased risk
of congenital
anomalies
Inadequate data to
determine risk of
“Grey Baby
Syndrome”		 No data 2012: Avoided during
pregnancy due to bone
marrow toxicity and the
possibility of a neonatal
syndrome that includes
circulatory collapse and
death		 2003: Teratogenic risk is
unlikely based on limited to fair
data. Data are insufficient to say
there is no risk. Maternal
treatment in late pregnancy may
be associated with vascular
collapse in the newborn infant		 C Pregnancy:
compatible
Ciprofloxacin
(11 articles)		 No clear
association with
congenital
anomalies		 Limited data:
Dosing adjustments
may be necessary		 2012: Avoided during
pregnancy because
fluoroquinolones are
toxic to developing
cartilage in
experimental animal
studies. No adverse
effects in human
pregnancy have been
documented		 2010:
Therapeutic doses are unlikely
to pose a substantial risk
Data are insufficient data to
state there is no risk		 C Pregnancy:
Human
data
suggest
low risk
Clindamycin
(7 articles)		 Data too limited
to draw a
conclusion		 Limited data:
Dosing adjustments
appear unnecessary		 2012: Based on
experimental animal
studies, not expected to
increase the risk of
congenital anomalies		 2007: Although a small risk
cannot be excluded, a high risk
of congenital anomalies in the
children of women treated with
clindamycin is unlikely		 B Pregnancy:
compatible
Doripenem
(0 articles)		 Data unavailable No data No summary 2011: Teratogenic risk is
undetermined		 B
Doxycycline
(6 articles)		 No clear
association with
specific
congenital
anomalies
Data too limited
to determine risk
of fetal tooth
staining, bone
growth delays
but unlikely		 Limited data:
Dosing adjustments
do not appear
necessary		 2011: Avoided in
pregnancy because
other tetracyclines
caused transient
suppression of bone
growth and with
staining of developing
teeth.
Based on experimental
animal studies and
human reports,
doxycycline is not
anticipated to increase
the risk of congenital
anomalies.		 2010: Therapeutic doses are
unlikely to pose a substantial
risk of fetal malformations
Data are insufficient to state
there is no risk. Risk of dental
staining is undetermined, but
may be substantial because
other tetracyclines cause
staining of primary dentition in
fetuses exposed during the
second and third trimester of
pregnancy		 D Pregnancy:
Contraindicated
in 2nd
and 3rd
trimesters
Levofloxacin
(3 articles)		 No data Limited data:
Dosing adjustments
may be necessary		 2011: Avoided during
pregnancy due to
cartilage toxicity in
juvenile animals.
Adverse effects in
human pregnancy have
not been demonstrated		 No summary C Pregnancy:
Human
data
suggest
low risk
Linezolid
(0 articles)		 Data unavailable No data 2012: Linezolid does
not cause congenital
malformations in mice
and rats at doses
causing maternal
toxicity, decreased
embryo viability and
decreased fetal weight.
There are no human
data.		 2011: Teratogenic risk is
undetermined		 C
Meropenem
(1 article)		 No data No data No summary No summary B Pregnancy:
Limited
human
data-
animal
studies
suggest
low risk
Moxifloxacin
(3 articles)		 No data Limited data:
Dosing adjustments
may be necessary		 2011:
Avoided during
pregnancy due to
concern about cartilage
toxicity shown in
juvenile laboratory
animals
Moxifloxacin is not
expected to increase the
risk of congenital
anomalies.		 No summary C
Penicillin
(15 articles)		 No increased risk
of congenital
anomalies		 Limited data:
Dosing adjustments
may be necessary to
maintain adequate
levels		 2011: Not believed to
increase adverse
pregnancy outcomes		 2007: No teratogenic risk based
on
good data		 B Pregnancy:
compatible
Rifampin
(11 articles)		 No increased risk
of congenital
anomalies		 No data 2011: Conflicting
animal studies, human
experience does not
suggest increase in
adverse pregnancy
outcome		 2007: Therapeutic disease
during pregnancy are unlikely
to pose a substantial teratogenic
risk but data are insufficient to
state there is no risk		 C Pregnancy:
compatible
Vancomycin
(6 articles)		 No increased risk
of congenital
anomalies		 Limited data:
Dosing adjustments
may be necessary
but can be
determined by
measuring serum
drug levels		 2009: Based on animal
studies, vancomycin is
not expected to increase
the risk of congenital
malformations. The few
human case reports are
reassuring.		 2006: Teratogenic risk is
undetermined		 B Pregnancy:
compatible
a

The Food and Drug Administration assigns pregnancy-related drug risks to 5 categories. Category A: adequate, well-controlled studies in humans have not shown an increased risk of fetal abnormalities. Category B: animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women or animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. Category C: animal studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women, or no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. Category D: adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus; however, the benefits of therapy may outweigh the potential risk. Category X: adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities; use is therefore contraindicated in women who are or may become pregnant.

b

Total 121 however 9 articles with data on multiple antibiotics