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Confusion about doxylamine safety in pregnancy

Debra S Kennedy and Ronald P Batagol
Med J Aust 2021; 214 (6): . || doi: 10.5694/mja2.50969
Published online: 5 April 2021

To the Editor: The Australian Therapeutic Goods Administration (TGA) categorisation system for prescribing medicines in pregnancy lists doxylamine as a Category A medicine — “Drugs which have been taken by a large number of pregnant women … without any proven increase in the frequency of malformations”.1


  • 1 MotherSafe, Sydney, NSW
  • 2 University of New South Wales, Sydney, NSW
  • 3 Melbourne, VIC



Competing interests:

No relevant disclosures.

  • 1. Therapeutic Goods Administration. Australian categorisation system for prescribing medicines in pregnancy. https://www.tga.gov.au/australian-categorisation-system-prescribing-medicines-pregnancy (viewed Feb 2021).
  • 2. Sheffield LJ, Batagol R. The creation of therapeutic orphans — or, what have we learnt from the Debendox fiasco? Med J Aust 1985; 143: 143–147.
  • 3. Brent R. Bendectin and birth defects: hopefully, the final chapter. Birth Defects Res A Clin Mol Teratol 2003; 67: 79–87.
  • 4. Lowe SA, Armstrong G, Beech A, et al. SOMANZ position paper on the management of nausea and vomiting in pregnancy and hyperemesis gravidarum. Aust N Z J Obstet Gynaecol 2020; 60: 34–43.
  • 5. Ritchie HE, Saini B, Twigg MJ, Kennedy D. Utilisation of a NSW teratology information service by pharmacists and patients referred by a pharmacist from 2000 to 2018. Aust N Z J Obstet Gynaecol 2020; 60: 412–418.
  • 6. Kennedy DS. A to X: the problem of categorisation of drugs in pregnancy — an Australian perspective. Med J Aust 2011; 195: 572–574. https://www.mja.com.au/journal/2012/196/3/x-problem-categorisation-drugs-pregnancy-australian-perspective-1

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