Drugs and their categories in pregnancy and breastfeeding


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Drug

TGA pregnancy category

Compatibility with breastfeeding

zanamivir

B1

caution, insufficient data

zidovudine

B3

avoid, insufficient data [NB1]

zinc lozenges

unlisted

compatible

zinc oxide

unlisted

compatible

zinc pyrithione

unlisted

compatible

zinc sulfate

unlisted (see product information)

compatible

ziprasidone

C

avoid, insufficient data

zoledronic acid

B3

caution, insufficient data

zolmitriptan

B3

caution, insufficient data

zolpidem

B3

compatible

zonisamide

D [NB11]

avoid

zopiclone

C

compatible

zuclopenthixol acetate

C

caution, insufficient data

zuclopenthixol decanoate

C

caution, insufficient data

zuclopenthixol dihydrochloride

C

caution, insufficient data

Therapeutic Goods Administration (TGA) pregnancy categorisation is from the Prescribing medicines in pregnancy database at the TGA website.

Definitions for compatibility with breastfeeding:

compatible—there are sufficient data available to demonstrate an acceptably low relative infant dose and/or no significant plasma concentrations and/or no adverse effects in breastfed infants
caution—there are insufficient data showing low relative infant dose and/or no significant plasma concentrations and/or no adverse effects in breastfed infants
avoid, insufficient data—there are no data on transfer into milk, or on plasma concentrations or adverse effects in the breastfed infant
avoid—significant plasma concentrations in exposed infants, or adverse effects in breastfed infants reported or predictable from the properties of the molecule.

Footnotes

 

NB1:

 
 

In Australia, breastfeeding is not recommended for HIV-positive women because of the possibility of HIV transmission and because suitable formula milk is readily available. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. The amount of drug transferred via milk in these cases is also of interest as it may exert antiviral actions in the infant.

NB2:

For further information on use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy, see General information on drug use in pregnancy: psychotropic drugs.

NB3:

Antiandrogens have the potential to feminise the male fetus, avoid in pregnancy.

NB4:

Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks postconception) after which they may affect the formation of the baby's teeth and cause discolouration.

NB5:

For further information on use of tricyclic antidepressants (TCAs) in pregnancy, see General information on drug use in pregnancy: psychotropic drugs.

NB6:

 

If an NSAID is required in a breastfeeding patient, diclofenac or ibuprofen is preferred.

NB7:

 

Absorption of eye drops into the maternal circulation is generally low, although there are occasional reports of systemic effects. Nevertheless, significant transfer into milk is unlikely.

NB8:

Large molecular weight proteins/polypeptides are unlikely to transfer into milk. In the absence of specific information, adverse effects in the infant are unlikely.

 

NB9:

 
 

Early reports of pregnancy outcomes in women treated with beta blockers in pregnancy, particularly dealing with propranolol, described a relatively high incidence of fetal growth restriction. This appears to be the basis for the C classification of the class of drugs. Since these findings were not from randomised studies, but were clinical descriptions of women who had underlying disorders known to be associated with an increased rate of both intrauterine fetal growth restriction and death, it is not possible to determine whether the described outcomes were due to the therapy or to the disorder for which therapy was prescribed. Subsequent evidence has indicated fetal growth restriction in hypertensive pregnant women treated with atenolol, but better fetal growth in women treated with another beta blocker, oxprenolol, than in women treated with methyldopa. This has been attributed to the intrinsic sympathomimetic activity inherent in this drug. No other fetal or neonatal problems have been attributed to beta-blocker therapy in pregnancy, and they are widely prescribed for the treatment of hypertension in this situation.

NB10:

Observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing erythromycin in early pregnancy.

NB11

For further information on use of antiepileptic drugs in pregnancy, see Antiepileptic drug therapy in women.

©Therapeutic Guidelines Limited (etg36demo, March 2012)