Volume 196 - Issue 3
A to X: the problem of categorisation of drugs in pregnancy — an Australian perspective
Author: Adam P Morton
Med J Aust 2012; 196 (3): 172. || doi: 10.5694/mja11.11498
Published online: 20 February 2012
Published online: 20 February 2012
To the Editor: Kennedy highlights a major source of frustration for mothers and health professionals — the accuracy of information regarding the safety of medications in pregnancy.1 The current categorisation system is inaccurate and outdated. Labetalol, used safely throughout pregnancy to treat hypertension for more than 30 years, has a Category C label because atenolol was associated with intrauterine growth retardation in one study.2,3 Proton pump inhibitors remain in Category C despite large studies demonstrating their safety in pregnancy.4 Hydroxychloroquine is in Category D despite extensive use in pregnancy without any adverse effect.5
The present A to X system could be simplified to three categories — safe, uncertain and definite risk, with a brief description of the information available, together with the references on which the evaluation is made. This could be freely available online and regularly updated as new information is published.
In addition, more rapid accumulation of evidence regarding the safety of newer medications in pregnancy and lactation is needed. At present, we rely on the publication of case reports and case series by single institutions. It would be valuable if a national or international database of de-identified information could be kept on mothers and babies who are exposed to drugs for which the safety is uncertain, so that outcomes may be followed, to better guide future parents and their health professionals regarding the safety of these medications in pregnancy and lactation.
Competing interests
No relevant disclosures.
References
- Kennedy DS. A to X: the problem of categorisation of drugs in pregnancy — an Australian perspective. Med J Aust 2011; 195: 572-574. 0_CHDBGJGG
- Michael CA. Use of labetalol in the treatment of severe hypertension during pregnancy. Br J Clin Pharmacol 1979 ; 8: 211S-215S. 0_i1142866
- Butters L, Kennedy S, Rubin PC. Atenolol in essential hypertension during pregnancy. BMJ 1990; 301: 587-589. 0_i1142868
- Gill SK, O’Brien L, Einarson TR, Koren G. The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis. Am J Gastroenterol 2009; 104: 1541-1545. 0_i1142870
- Costedoat-Chalumeau N, Amoura Z, Huong DL, et al. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases. Review of the literature. Autoimmun Rev 2005; 4: 111-115. 0_i1142874