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The following tables summarize safety of drug use in pregnancy and lactation.
Medications of herbal origin are excluded from the list.
Under the column "Drug-Pregnancy Categories", letters A, B, C, D, and X signify the FDA Pregnancy
categories.
These five categories indicate the potential of a systemically-absorbed drug to cause birth defects;
the key differentiation among the categories rests upon the reliability of documentation and the
risk: benefit ratio.
A : Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first
trimester with no evidence of risk in later trimesters. The possibility of fetal harm
appears remote.
B : Either animal-reproductive studies have not demonstrated a fetal risk but there are no
controlled studies in pregnant women, or animal-reproduction studies have shown an
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 risk in later
trimesters.
C : Either studies in animals have revealed adverse effects on the fetus (teratogenic or
embryocidal effects 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
benefits justify the potential risk to the fetus.
D : There is positive evidence of human fetal risk, but the benefit from use in pregnant
women may be acceptable despite the risk (If the drug is needed for life threatening
situations or for serious diseases for which safer drugs can not be used or are
ineffective).
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.
For drugs not FDA approved; other classification systems were used to identify the pregnancy
categories, whenever possible, the two other systems used are:
1. Micromedex Pregnancy Ratings:
Fetal risk has been Evidence has demonstrated fetal abnormalities or risks when used
demonstrated during pregnancy or in women of childbearing potential. An
alternative to this drug should be prescribed during pregnancy or
in women of childbearing potential.
Fetal risk is minimal The weight of an adequate body of evidence suggests this drug
poses minimal risk when used in pregnant women or women of
childbearing potential.
A : Drugs which have been taken by a large number of pregnant women and women of
childbearing age without any proven increase in the frequency of malformations or
other direct or indirect harmful effects on the fetus having been observed.
B1 : Drugs which have been taken by only a limited number of pregnant women and women
of childbearing age, without an increase in the frequency of malformation or other
direct or indirect harmful effects on the human fetus having been observed. Studies in
animals have not shown evidence of an increased occurrence of fetal damage.
B2 : Drugs which have been taken by only a limited number of pregnant women and women
of childbearing age, without an increase in the frequency of malformation or other
direct or indirect harmful effects on the human fetus having been observed. Studies in
animals are inadequate or may be lacking, but available data show no evidence of an
increased occurrence of fetal damage.
B3 : Drugs which have been taken by only a limited number of pregnant women and women
of childbearing age, without an increase in the frequency of malformation or other
direct or indirect harmful effects on the human fetus having been observed. Studies in
animals have shown evidence of an increased occurrence of fetal damage, the
Note: For drugs in the B1, B2 and B3 categories, human data are lacking or inadequate and sub-
categorization is therefore based on available animal data. The allocation of a B category does not
imply greater safety than the C category. Drugs in category D are not absolutely contraindicated in
pregnancy (e.g. anticonvulsants). Moreover, in some cases the 'D' category has been assigned on
the basis of 'suspicion'.
If there was no data under the previous three categorizations, the drug-pregnancy category is
assigned as "N/A"
Data for medication use during breast feeding, are complied from FDA data, WHO data and
Micromedex Lactation Ratings:
1. WHO Lactation Ratings:
Avoid breastfeeding
Avoid breastfeeding if possible. May inhibit lactation
Avoid breastfeeding if possible. Monitor infant for side effects
Compatible with breastfeeding
Compatible with breastfeeding. Monitor infant for side effects
WHO documentation states insufficient data
Infant risk has been Evidence and/or expert consensus has demonstrated harmful
demonstrated infant effects when used during breastfeeding. An alternative to
this drug should be prescribed or patients should be advised to
discontinue breastfeeding.
Infant risk is minimal The weight of an adequate body of evidence and/or expert
consensus suggests this drug poses minimal risk to the infant when
used during breastfeeding
Milk effects are Evidence suggests this drug may alter milk production or
possible composition. If an alternative to this drug is not prescribed,
monitor the infant for adverse effects and/or adequate milk intake