New Regulations for Food Labels and Breastfeeding Risks.

The Food and Drug Administration has released new labeling rules that are intended to give doctors a better understanding of how specific drugs may benefit or harm their pregnant and breastfeeding patients. A final draft rule, which is scheduled to be published in the National Register on Thursday, will replace a decades-old labeling system that used letters of the alphabet to describe risk. At a news conference Wednesday, Dr. Sandra Kweder, deputy director of the office of new drugs at the FDA’s Center for Drug Evaluation and Research, told reporters that the old letter system was “extraordinarily misleading.” “Instead, the new format will require that labeling include a summary of the risks of using a drug during pregnancy and while breastfeeding an infant,” Kweder said. “This information has been in labeling all along, but it’s been scattered throughout the label and very difficult to find. We’re putting it all in one place,” Kweder said. The new regulation, which takes affect June 30, concerns physician prescribing information, or so-called package inserts, and will not change the labeling consumers find on the outside of pill containers that they get at the pharmacy, officials said. Under the new rule, package inserts will now feature three subsections entitled “pregnancy,” “lactation” and “females and males of reproductive potential.” The pregnancy subsection will include inform...
Source: Cord Blood News - Category: Perinatology & Neonatology Authors: Tags: babies brain development medical research parents pregnancy Uncategorized breast feeding FDA food labels Source Type: blogs