FDA Issues Label Change for Drugs Used During Pregnancy and Nursing

The FDA issued a label change for rules governing how prescription drugs and biologics are used during pregnancy and breastfeeding.

The decision, which has been in the works since 2008, will impact >6 million pregnancies in the United States involving women who need to take 3 to 5 prescription drugs, on average, during gestation.

The new rule creates 3 detailed subsections on the labels of these drugs entitled "Pregnancy," "Lactation," and "Females and Males of Reproductive Potential". These will replace the current system of using the product letter categories A, B, C, D, and X to classify the risks of using prescription drugs during pregnancy.

Under the new rule, the pregnancy subsection will provide data on dosing and potential risks to the developing fetus and will require manufacturers to provide information on whether there is a registry that collects and maintains data on how pregnant women are affected when they use the product.

Information on drug labels about the existence of pregnancy registries has been previously recommended but not required until now.

The lactation subsection will offer information about taking the drug while breastfeeding, such as the amount of drug in breast milk and the implications for breastfeeding infants.

The final subsection will include information about pregnancy testing, contraception, and infertility as it relates to the drug.

The changes will go into effect by June 30 and will require newly approved drug and biologic applications to employ the new format immediately, while amended requirements for older products will be phased in gradually.

The FDA is also issuing a draft guidance for the industry to help manufacturers comply with the new labeling requirements.—Kerri Fitzgerald

Source: Thomson Reuters. 2014; FDA changes labeling for drugs used during pregnancy, lactation.