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Transfer of rofecoxib into human milk.

Gardiner SJ, Begg EJ, Zhang M, Hughes RC

Department of Clinical Pharmacology, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand. sharon.gardiner@cdhb.govt.nz

OBJECTIVE: To determine the milk-to-plasma (M/P) concentration ratio of rofecoxib in lactating mothers and estimate likely infant exposure. METHODS: Rofecoxib 25 mg was given to six lactating women at weaning. Blood and milk were sampled up to 72 h post-dose for determination of rofecoxib concentrations. M/P ratios were derived from the respective area under the concentration-time curves. The infant 'dose' in milk was estimated and expressed as a percentage of the maternal dose, corrected for weight. RESULTS: The median (range) M/P ratio and infant 'dose' were 0.25 (0.16-0.32) and 2.1% (1.8-3.2%), respectively. CONCLUSIONS: The use of rofecoxib during breastfeeding is unlikely to pose harm to the suckling infant on the basis of low transfer into human milk.

Published 26 July 2005 in Eur J Clin Pharmacol, 61(5): 405-8.
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