News article

FDA proposes accurate labeling for drugs in lactation

May 29, 2008

The U.S. Food and Drug Administration (FDA) is proposing major revisions to prescription drug labeling to provide more complete information about the effects of medicines used during pregnancy and breast-feeding. The lactation information proposed would now be an evidence-based risk assessment of the effects of the drug on milk production, how much of the drug is present in milk compared to the amount present when standard infant doses would be administered, and the effects of the drug on the infant.

A study published last year in Annals of Pharmacotherapy found that less than 25% of drugs studied from retail pharmacies had accurate safety information. “This FDA proposal would be a huge advance for breastfeeding,” said Melissa Bartick, MD, a Massachusetts internist and one of the authors of the Annals study. “Typically, retail pharmacies paste on labels saying not to use the drug in breastfeeding, or to ask one’s doctor or pharmacist — even for drugs well known to be safe.”

The FDA action follows in the heels of the establishment in the spring of 1996 of of LactMed, a free online safety database from the National Library of Medicine. LactMed is a very reliable source, according to the Annals study.

To learn how to submit comments to the FDA, read the full FDA press release.