Mill River Pediatrics - Comment

I am pleased to see that FDA is taking a stance which will be more supportive of breastfeeding than the current labelling. Many women stop breastfeeding without any physician input when a pharmacist reports that a drug is not known to be safe during breastfeeding. Many physicians continue to follow the recommendations in the PDR despite reliable and more up to date information elsewhere, particularly at Toxicology.net. Occassionally women do harm by not taking medications that will benefit themselves. I am concerned that the information published in this format will not go far enough to explain that the risks of not receiving breastmilk are substantial and that infants can be monitored for any adverse effects by parents, caregivers and healthcare professionals. Will the information be updated often enough to be useful? Will statements include reassuring comments such as "This drug is approved for use in infants." and "The amount of drug transferred in the milk is low." and "Even with transfer of drug into the milk the absorption into the baby's bloodstream is limited (or markedly decreased by a first pass hepatic metabolism)." etc. As with the system of using letters for pregnancy risk it is very important that the labelling reflect not only the facts but the risk to the infant of a small amount of drug as compared to the enormous risk of infection, decreased attachment and security, decreased development and increased risk of many chronic conditions when a baby is not breastfed.