Assessing the safety of drugs and breast-feeding

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Editor, – Christine Jenkins' letter (Aust Prescr 1998;21:31) concerning budesonide and other corticosteroids, whilst breast-feeding, epitomises the health professional's perennial dilemma in this area of health information. Indeed, budesonide is a classic case of a valuable drug used for the management of a medical condition, where negligible quantities are excreted into breast milk, but where, because of actual or perceived medico-legal restraints, the manufacturer warns against using the drug whilst breast-feeding. Meanwhile, we promote public awareness of the need for optimum medication management of asthma! Susan Parker's reply that Astra Pharmaceuticals would be happy to include a (TGA-approved) statement for those drugs where it is clear that 'transfer into breast milk is unlikely' is a refreshing and welcome approach which could be explored by other manufacturers.

In my 1996 Drugs and breast-feeding booklet1,I identified some 70 drugs where studies had measured the quantities transferred in milk, and, uniquely, for this type of booklet, estimated the mg/kg dose that the infant would receive. I believe that this approach, in addition to, where applicable, clinical experience suggesting that a drug may be used whilst breast-feeding, would be of great practical assistance to health practitioners.

The problem in assessing safety during lactation, compared to the drugs and pregnancy situation, is that we lack a categorisation system. In the late 1980s,the Scandinavian countries developed a categorisation system for drugs used in breast-feeding, whilst in the U.S.A., the Pediatric Academy periodically publishes safety recommendations for drugs used during lactation. In Australia, however, neither systematic nor peer-reviewed evaluation of drug safety during lactation exists. In my view, they are long overdue.

R. Batagol
Pharmacy and Drug Information Consultant
Nunawading, Vic.

References

  1. Batagol R. Drugs and breast-feeding. Melbourne: C.S.L. Ltd, 1996.