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Drugs and their categories in pregnancy and breastfeeding


Drug

TGA pregnancy category [

Compatibility with breastfeeding [B1

compatible

magnesium formulations

See individual drugs below

See individual drugs below

magnesium amino acid chelate

unlisted (see product information)

compatible

magnesium aspartate

unlisted (see product information)

compatible

magnesium chloride

unlisted (see product information)

caution, insufficient data

magnesium citrate

unlisted (see product information)

compatible

magnesium diglycinate

unlisted (see product information)

compatible

magnesium hydroxide

unlisted (see product information)

compatible

magnesium oxide

unlisted (see product information)

compatible

magnesium phosphate

unlisted (see product information)

compatible

magnesium sulfate

unlisted (see product information)

compatible

malathion

B2

caution, insufficient data

mannitol

B2

compatible

mebendazole

B3

compatible

mebeverine

B2

caution, insufficient data

medroxyprogesterone

IM contraceptive dose: A

oral high dose more than 30 mg daily: D

IM contraceptive dose: compatible

oral: compatible

mefenamic acid

C [B3

compatible

melatonin

B3

use with caution

meloxicam

C [B2

avoid, insufficient data

mepivacaine

A

use with caution

mercaptopurine

D

avoid

meropenem

B2

compatible; may cause diarrhoea in infant

mesalazine

C

compatible; may cause diarrhoea in infant

mesna

B1

avoid, insufficient data

mestranol

B3

combined oral contraceptive: compatible from 6 weeks postpartum; earlier estrogen use may suppress lactation

metaraminol

C

caution, insufficient data

metformin

C

compatible

methadone

C

compatible

methotrexate

D [B2

avoid, insufficient data

methoxyflurane

C

use with caution

methyldopa

A

compatible

methylene blue

D

caution, insufficient data

methylprednisolone aceponate

topical use: C

topical use: compatible

methylprednisolone

systemic use: A [C

avoid, insufficient data

metoclopramide

A

compatible

metoprolol

C [B2

use with caution

micafungin

B3

use with caution

miconazole

A

compatible

midazolam

C

compatible; monitor infant for drowsiness

midodrine

unlisted

caution, insufficient data

mifepristone

unlisted (see product information)

compatible

milrinone

B3

caution, insufficient data

minocycline

D [B3

compatible

misoprostol

X

compatible

moclobemide

B3

compatible

modafinil

B3

avoid, insufficient data

mometasone furoate

B3

compatible

montelukast

B1

compatible

morphine

C

compatible in usual analgesic doses used in the perinatal period; use with caution with high-dose or extended-release preparations, as there are no data

moxifloxacin

B3

use with caution; may cause diarrhoea in infant

moxonidine

B3

avoid, insufficient data

mupirocin

B1

compatible

mycophenolate mofetil

D [D [NB5]

avoid, insufficient data

NB1:  Therapeutic Goods Administration (TGA) pregnancy categorisation is from the Prescribing medicines in pregnancy database at the TGA website.

NB2:  Definitions for compatibility with breastfeeding:
compatible—there are sufficient data to demonstrate:
     • an acceptably low relative infant dose and/or
     • no significant plasma concentration in breastfed infants and/or
     • no adverse effects in breastfed infants.
use with caution—minor adverse effects in the breastfed infant have been reported, or there are insufficient data to demonstrate:
     • an acceptably low relative infant dose and/or
     • no significant plasma concentration in breastfed infants and/or
     • no adverse effects in breastfed infants.
     However, the characteristics of the drug suggest significant adverse effects are unlikely. Consider monitoring the infant for adverse effects.
avoid, insufficient data—the characteristics of the drug suggest significant adverse effects are possible and there are insufficient data to demonstrate:
     • an acceptably low relative infant dose and/or
     • no significant plasma concentration in breastfed infants and/or
     • no adverse effects in breastfed infants.
avoid—there are sufficient data to demonstrate:
     • an unacceptably high relative infant dose and/or
     • significant plasma concentration in breastfed infants and/or
     • significant adverse effects in breastfed infants.

NB3:  For discussion of nonsteroidal anti-inflammatory drug (NSAID) use for musculoskeletal conditions in women who are pregnant, see NSAIDs and reproductive health in women.

NB4:  If an NSAID is required in a breastfeeding patient, diclofenac or ibuprofen is preferred.

NB5:  For discussion of immunomodulatory drug use for rheumatological diseases in women who are pregnant, see Immunomodulatory drug use and reproductive health in adults with rheumatological diseases.

NB6:  Early reports of pregnancy outcomes in women treated with beta blockers (particularly propranolol) during pregnancy described a relatively high incidence of fetal growth restriction. This appears to be the basis for the C classification of this class of drugs. Since these findings were not from randomised studies, 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 restricted fetal growth in hypertensive pregnant women treated with atenolol, but better fetal growth in women treated with oxprenolol, than in women treated with methyldopa. 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 pregnancy.

NB7:  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.

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

The pregnancy categorisation system only applies to recommended therapeutic doses. It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as:

  • overdose
  • occupational exposure
  • other situations in which the recommended therapeutic dose has been exceeded.

The Australian categorisation system is not hierarchical.

The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.

  • Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories.
  • Subcategorisation of the B category is based on animal data.
  • The allocation of a B category does not imply greater safety than a C category.
  • Medicines in category D are not absolutely contraindicated during pregnancy.

Because of legal considerations in Australia, sponsor companies have, in some cases, applied a more restrictive category than can be justified on the basis of the available data.

For pharmaceutical products containing two or more active ingredients, the categorisation of the combination is based on the active ingredient with the most restrictive pregnancy categorisation.

The TGA pregnancy category should not be the sole basis of decision-making in the use of a drug during pregnancy, because it does not provide information about the balance of harms and benefits for a particular woman and fetus. Furthermore, the category does not indicate the stage(s) of fetal development that might be affected by drug exposure and may not reflect the most up-to-date information about the drug’s use in pregnancy.

  • Category A
  • Category B1
  • Category B2
  • Category B3
  • Category C
  • Category D
  • Category X

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. Specialised texts should be consulted for further details. [Note 1]

Note 1:  Category C in the Australian and Swedish categorisations of risk is a pharmacological effect category and differs from the US Food and Drug Administration (FDA) categorisation (where category C indicates greater likelihood of risk than B on the basis of adverse effects of any type in animal studies).

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. Specialised 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.

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

The pregnancy categorisation system only applies to recommended therapeutic doses. It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as:

  • overdose
  • occupational exposure
  • other situations in which the recommended therapeutic dose has been exceeded.
The Australian categorisation system is not hierarchical.

The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.

  • Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories.
  • Subcategorisation of the B category is based on animal data.
  • The allocation of a B category does not imply greater safety than a C category.
  • Medicines in category D are not absolutely contraindicated during pregnancy.

Because of legal considerations in Australia, sponsor companies have, in some cases, applied a more restrictive category than can be justified on the basis of the available data.

For pharmaceutical products containing two or more active ingredients, the categorisation of the combination is based on the active ingredient with the most restrictive pregnancy categorisation.

The TGA pregnancy category should not be the sole basis of decision-making in the use of a drug during pregnancy, because it does not provide information about the balance of harms and benefits for a particular woman and fetus. Furthermore, the category does not indicate the stage(s) of fetal development that might be affected by drug exposure and may not reflect the most up-to-date information about the drug’s use in pregnancy.

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. Specialised texts should be consulted for further details. [Note 1]

Note 1:  Category C in the Australian and Swedish categorisations of risk is a pharmacological effect category and differs from the US Food and Drug Administration (FDA) categorisation (where category C indicates greater likelihood of risk than B on the basis of adverse effects of any type in animal studies).

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. Specialised 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.