New FDA rule improves labeling of drugs during pregnancy

The FDA has implemented its Pregnancy and Lactation Labeling Rule to improve labeling on prescription drugs for pregnant and breastfeeding women. The agency determined that the pregnancy letter category system was too simplistic and did not capture the complexities of available risk information and risk-benefit considerations in relation to prescription drug labeling. The Pregnancy and Lactation Labeling Rule requires pharmaceutical manufacturers to detail the risks and benefits of prescription drugs or biological products for the mother, fetus, infant, and people planning to conceive. The rule also requires drug manufacturers to update drug and biological product labeling when new information becomes available.