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Drug Safety in Pregnancy and Breastfeeding PDF
Drug Safety in Pregnancy and Breastfeeding PDF
Bisoprolol Fumarate 2.5/5 C1 Human Data Suggest Risk in 2nd and No Human Data—Potential
mg Tab. C2 3rd Trimesters3 Toxicity3
Bromhexine is expected to
Available data find no ill effects
enter breast milk, and
Bromhexine HCl 8mg Tab. A1 following oral administration.
therefore should be avoided
Precautions should be practised4
during lactation4
No clinical data on exposed Administration of Symbicort
pregnancies are available. The should only be considered if
Budesonide 160mcg + C1
lowest effective dose of budesonide the expected benefit to the
Formoterol 4.5mcg Inhaler B32
needed to maintain adequate mother is greater than any
asthma control should be used4 possible risk to the child4
Item Pregnancy Category Use in pregnancy Use in lactation
Probably compatible3
The amounts of inhaled
budesonide excreted into
Compatible3
B1 breast milk are minute and
Budesonide 64mcg Nasal This drug should be used in
A2 infant exposure is negligible.
Spray pregnancy only if the benefit
Most experts consider oral and
outweighs the risk to the fetus3
inhaled corticosteroids
acceptable to use during
breastfeeding5
C1
Calcitriol 0.25mcg Cap. Compatible3 Compatible3
B32
Calcium Carbonate 500mg
C1 Compatible3 Compatible3
Tab.
Animal studies are not available.
There is no controlled data in
human pregnancy. The background
birth defect and miscarriage risk for
Calcium Gluconate 10% Inj. C1 Infant risk cannot be ruled out7
the indicated population is not
Exempt2
known. In the US general
population, the estimated major
birth defect risk is 2 to 4% and the
miscarriage risk is 15 to 20%4
D1 Human Data Suggest Risk in 2nd and
Captopril 25mg Tab. Compatible3
D2 3rd Trimesters3
D1 Compatible—Maternal Benefit >>
Carbamazepine 200mg Tab. Compatible3
D2 Embryo–Fetal Risk3
Carbimazole 5mg Tab. D1 Human Data Suggest Risk3 Compatible3
B1
Ceftriaxone 250mg Inj. ‘ Compatible3 Compatible3
B12
Cefuroxime Axetil 250mg B1
Compatible3 Compatible3
Tab. B12
Cephalexin Monohydrate B1
Compatible3 Compatible3
250mg Capsule A2
Cetirizine Dihydrochloride B1 Limited Human Data—Animal Data No Human Data—Probably
10mg Tab. B22 Suggest Low Risk3 Compatible3
Charcoal Activated 250mg C1
Not documented4 Not documented4
Tab. B22
There is no evidence on the
Chloramphenicol 0.5% w/v safety in infants exposed via
Eye Drops breastfeeding after maternal
Compatible3 use; risks of toxicity in the
No association between topical infant are theoretical and not
Chloramphenicol 1% Eye C1
chloramphenicol in the 1st trimester supported by direct clinical
Ointment A2
of pregnancy and major congenital evidence. Therefore, the use of
malformations8 chloramphenicol via the ear or
eye can proceed with caution.
Chloramphenicol 5% w/v Ear However, it should be avoided
Drops if there is a past or family
history of blood dyscrasias9
Item Pregnancy Category Use in pregnancy Use in lactation
No Human Data—Probably
Chlorhexidine 1% Cream B1 Compatible3
Compatible3
Not assigned1 Limited human data- Animal data No human data- Potential
Fenofibrate 145mg Tab
B2 suggest risk3 toxicity3
Item Pregnancy Category Use in pregnancy Use in lactation
Problems in humans have not been
Ferrous Fumarate 200mg 1 Problem in humans have not
Not assigned documented with orally intake of
Tab. been documented6
daily recommended amounts4
Fluorescein Sodium C1 Limited human data- Animal data Limited human data- Probably
Ophthalmic Strips B22 suggest low risk3 compatible3
Fluticasone Propionate C1
Use with caution6 Use with caution6
125mcg Inhaler B32
C1 Human Data Suggest Risk in 3rd Limited Human Data—
Fluvoxamine 50mg Tab.
C2 Trimester3 Potential Toxicity3
A1
Folic Acid 5mg Tab. Compatible3 Compatible3
A2
Frusemide 20mg/2ml Inj.
C1 Limited human data- Probably
Human data suggest low risk3
C2 compatible3
Frusemide 40mg Tab.
Compatible. Compatible.
Does not usually pose a risk to the IV magnesium increases milk
fetus or newborn. Longterm magnesium concentrations
infusions of magnesium may be only slightly and oral
Magnesium Sulfate D1 associated with sustained absorption of magnesium by
2.47gm/5ml Inj. D2 hypocalcemia in the fetus resulting the infant is poor, so maternal
in congenital rickets. Neonatal magnesium therapy is not
neurologic depression may occur expected to affect the
with respiratory depression, muscle breastfed infant's serum
weakness, and loss of reflexes3 magnesium3
D1
Magnesium Sulphate Paste Compatible3 Compatible3
D2
Item Pregnancy Category Use in pregnancy Use in lactation
Meclozine may be distributed
into breast milk. However,
problems in humans have not
been documented. Due to its
anticholinergic actions,
Meclozine may inhibit
lactation. Therefore, it is not
Meclozine is not expected to harm
recommended for lactating
an unborn baby.
women unless the expected
Meclozine HCL 25mg + Meclozine HCL: B1 Pyridoxine is considered to be safe
benefits outweigh any
Pyridoxine 50mg Tab. Pyridoxine: A1 for use during pregnancy. Pyridoxine
potential risk.
requirements increase during
Pyridoxine is excreted into
pregnancy.6
milk. While some have
expressed concern over the
inhibition of breast milk
secretion by Pyridoxine, others
have cautioned that Pyridoxine
deficiency may cause seizures
in neonate.6
Meclozine may be distributed
into breast milk. However,
problems in humans have not
been documented. Due to its
anticholinergic actions,
Meclozine may inhibit
lactation. Therefore, it is not
Meclozine is not expected to harm
recommended for lactating
an unborn baby.
women unless the expected
Meclozine HCL 25mg + Meclozine HCL: B1 Pyridoxine is considered to be safe
benefits outweigh any
Pyridoxine 50mg Tab. Pyridoxine: A1 for use during pregnancy. Pyridoxine
potential risk.
requirements increase during
Pyridoxine is excreted into
pregnancy.6
milk. While some have
expressed concern over the
inhibition of breast milk
secretion by Pyridoxine, others
have cautioned that Pyridoxine
deficiency may cause seizures
in neonate.6
Medroxyprogesterone 5mg X1
Contraindicated3 Compatible3
Tab. D2
C ;D(in 3rd trimester
Human Data Suggest Risk in 1st and Limited Human Data—
Mefenamic Acid 250mg Tab. or near delivery)1
3rd Trimesters3 Probably Compatible3
C2
Human data suggest risk in 1st and
C1
3rd trimesters3 No human data- Probably
Meloxicam 7.5mg Tab. 3rd trimester: D1
Avoid during 3rd trimester or near compatible3
C2
delivery
Metformin HCl +
B1
Glibenclamide 500/2.5mg Not recommended6 Not recommended6
C2
Tab.
Item Pregnancy Category Use in pregnancy Use in lactation
B1
Metformin HCL 500mg Tab. Human Data Suggest Low Risk3 Compatible3
C2
B1
Metformin XR 500mg Tab. Human Data Suggest Low Risk3 Compatible3
C2
B1 Limited Human Data—
Methyldopa 250 mg Tab. Compatible3
A2 Probably Compatible3
Compatible3
Metoclopramide HCL 10mg B1 Metoclopramide is excreted in
Compatible. Metoclopramide has
Tab. A2 variable amounts in breastmilk.
been used during all stages of
Although most studies have
pregnancy. No evidence of embryo,
found no adverse effects in
fetal, or newborn harm has been
breastfed infants during
Metoclopramide Hcl B1 found in human and animal studies3
maternal metoclopramide use,
10mg/2ml Inj. A2 many did not adequately
observe for side effects5
Metoprolol Tartrate 100mg C1 Human Data Suggest Risk in 2nd and Limited Human Data—
Tab. C2 3rd Trimesters3 Potential Toxicity3
Hold Breastfeeding (Single
1
B Dose) Limited. Human Data—
Metronidazole 200mg Tab. Human Data Suggest Low Risk3
B22 Potential Toxicity (Divided
Dose)3
Miconazole Nitrate 2% C1
Compatible3 Compatible3
Cream A2
No human data- Probably
compatible3
Very low levels appear in
B1 Limited human data- Probably
Montelukast 10mg Tab breastmilk. Amounts ingested
B12 compatible3
by the infant would not be
expected to cause any adverse
effects5
C1 No human data- Probably
Naloxone HCl 0.4mg/ml Inj. Compatible3
B12 compatible3
D1 No Human Data—Probably
Neomycin 0.5% Cream Human Data Suggest Low Risk3
D2 Compatible3
B1
Paracetamol 500mg Tab Human Data Suggest Low Risk3 Compatible3
A2
Item Pregnancy Category Use in pregnancy Use in lactation
Perindopril 4mg/8mg/4mg + D1
Contraindicated6 Contraindicated6
indapamide 1.25mg D2
Phenoxymethylpenicillin B1
Compatible3 Compatible3
125mg Tab A2
-
Pizotifen 0.5mg Tab. Use with caution Use with caution
B12
Potassium Chloride SR C1
Compatible3 Compatible3
600mg Tab Exempt2
C/D1
Prednisolone 5mg Tab. Human Data Suggest Risk3 Compatible3
A2
A1
Pyridoxine 10mg Tab. Compatible3 Compatible3
Exempt2
C1 No Human Data—Probably
Salbutamol 2mg Tab. Compatible3
A2 Compatible3
Silver Sulphadiazine 1% B1
Contraindicated6 Contraindicated6
Cream C2
X1
Simvastatin 10mg/40mg Contraindicated3 Contraindicated3
D2
Sodium Bicarbonate 8.4% Inj. C1 Limited human data- Animal data No human data- Potential
(10ml) - suggest low risk toxicity3
Sulphamethoxazole 400 mg
D1 Human Data Suggest Risk in 3rd Limited Human Data—Potential
& Trimethoprim 80 mg
D2 Trimester3 Toxicity3
(Co-Trimoxazole) Tab.
Telmisartan 40mg/ 80mg/ D1 Human Data Suggest Risk in 2nd and No Human Data—Probably
80+12.5mg HCTZ D2 3rd Trimesters3 Compatible3
Tranexamic Acid 250mg Limited Human Data—Animal Data Limited Human Data—Probably
B1
Capsule Suggest Low 3 Compatible3
Unknown whether
tropicamide/metabolites are
excreted in human milk. A
decision must be made
whether to discontinue
There are no or limited amount of breastfeeding or to
C1 data from the use of Tropicamide in discontinue/abstain from
Tropicamide 1% Eye Drops
B22 pregnant women. It is not tropicamide4
recommended during pregnancy4 A single dose of is not likely to
interfere with breastfeeding;
however, during long-term use,
observe the infant for signs of
decreased lactation (e.g.,
insatiety, poor weight gain)5
Valsartan 80mg & HCTZ D1 Human Data Suggest Risk in 2nd and No Human Data—Probably
12.5mg Tab. D2 3rd Trimesters3 Compatible3
D1 Human data suggest risk in 2nd and
Valsartan 80mg Tab Probably compatible 3
D2 3rd trimesters 3
C1 Limited Human Data—Probably
Verapamil HCL 40mg Tab. Compatible3
C2 Compatible3
There are no adequate data from It is unknown whether
the use of vildagliptin in pregnant vildagliptin is excreted in
women. Studies in animals have human milk. Animal studies
C1
Vildagliptin 50mg Tab shown reproductive toxicity at high have shown excretion of
B32
doses. Due to lack of human data, it vildagliptin in milk. It should
should not be used during not be used during breast-
pregnancy4 feeding4
C1
Vitamin K1 1mg/ml Inj. Compatible3 Compatible3
-
REFERENCES
1- US FDA
2. AU TGA
3. Drugs in pregnancy and lactation, 11th Edition (BRIGGS)
4. Product Information Leaflet
5. LACTMED
6.MIMS
7. Micromedex
8. Thomseth V, Cejvanovic V, Jimenez-Solem E, Petersen K, Poulsen H, Andersen J. Exposure to topical
chloramphenicol during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study.
Acta Ophthalmologica. 2015;93(7):651-653.
9. United Kingdom National Health Service (NHS)
10. Tanaka S, Kanagawa T, Momma K, Hori S, Satoh H, Nagamatsu T et al. Prediction of sustained fetal toxicity
induced by ketoprofen based on PK/PD analysis using human placental perfusion and rat toxicity data. British
Journal of Clinical Pharmacology. 2017;83(11):2503-2516.
APPENDIX A: Drug safety in Pregnancy classification (US FDA)
Category A Controlled studies in 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.
Category B Either animal-reproduction 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 that was not confirmed
in controlled studies in women in the first trimester.
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 life-threatening 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.
Category 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.
Category 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.
Category 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.
Category 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 significance of
which is considered uncertain in humans.
Category C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful
effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Accompanying texts should be consulted for further details.
Category D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased
incidence of human fetal malformations or irreversible damage. These drugs may also have adverse
pharmacological effects. Accompanying texts should be consulted for further details.
Category X Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in
pregnancy or when there is a possibility of pregnancy.