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.
Pharmacy and Drug Information Consultant
- Batagol R. Drugs and breast-feeding. Melbourne: C.S.L. Ltd, 1996.