The FDA has a new labeling system, the Pregnancy and Lactation Labeling System, for prescription medicine. It does not affect over the counter labels. It will describe the known risks in sentence format, instead of using the letter categories. The label will cover the medication’s effects on reproductive potential, specific trimesters, breastfeeding an infant, and if the medication use should be minimized or completely avoided. It will also include information on a pregnancy exposure registry. Changes were implemented on June 30, 2015.
Key Takeaways:
- The FDA has changed its labeling system for pregnancies and breast feeding.
- They are switching from a letter system to actual descriptions.
- It should make labeling of medicine more clear to understand it’s potential risks.
“The new Pregnancy & Lactation Labeling for prescription medicines will include more helpful information about a medication’s risks to pregnant women, the developing baby, and babies that are breastfed.”
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