Therapeutic goods exempted from pregnancy categorisation

4 May 2011

The Prescribing Medicines in Pregnancy Database does not include all medicines approved for use in Australia. Certain classes of medicines are exempted from receiving a pregnancy category, although some medicines within these classes have been assigned a pregnancy classification when they were included in the Australian Register of Therapeutic Goods.

Medicines exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

Generally exempted classes of medicines:

  • All medical devices (including prostheses, surgical implants, ostomy aids, surgical dressings, contraceptive devices, etc.)
  • Antiflatulents (silicones)
  • Antigen preparations for desensitisation
  • Antihaemorrhagics: antifibrinolytics, fibrinogen, blood coagulation factors
  • Antivenoms & antitoxins
  • Aromatherapy
  • Certain anti-poisoning agents: potassium iodide
  • Certain laxatives: lactulose, bulk producers and enemas
  • Charcoal preparations
  • Contact lens preparations
  • Diagnostic agents (urinalysis agents, ocular staining agents etc.)
  • Digestives, including enzymes
  • Ear preparations for topical use
  • Enzymes (haematological), including fibrinolytics and hyaluronidase
  • Herbal medicines
  • Homeopathic medicines
  • Hormones that are indicated only for termination of pregnancy, postmenopausal substitution therapy, male hypogonadism, amenorrhoea, cystic glandular hyperplasia, or prostatic cancer
  • Infant formulas
  • Insulins and glucagon
  • Keratolytics, cleansers, bath additives
  • Mineral supplements
  • Mouth preparations excluding those containing benzydamine
  • Nutritional supplements
  • Ocular irrigants
  • Parenteral nutrition preparations
  • Plasma substitutes and intravenous solutions, including solutions for intravenous feeding
  • Scabicides, except when containing DDT, lindane or maldison (malathion)
  • Sera and gammaglobulins
  • Topical antirheumatics
  • Topical nasal decongestants, sympathomimetics and combinations excluding steroids
  • Topical organoheparinoids
  • Topical preparations for haemorrhoids, except those containing corticosteroids
  • Traditional medicines (Ayurvedic, Traditional Chinese, Indigenous)
  • Urinary sediment solvents
  • Varicose vein therapies
  • Vitamins (other than vitamin A and nicotinic acid)
  • Zinc bandages

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