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FDA updates pregnancy, lactation section requirements for drug labels

Wednesday, January 07 2015 | Comments
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The Food and Drug Administration published a new rule that sets standards for how information about using prescription drugs during pregnancy and breastfeeding is presented in drug labels.

The new rule, referred to as the Pregnancy and Lactation Labeling Rule, requires changes to the content and format for prescription drug label information. The changes will help providers when counseling pregnant women and nursing mothers who require prescription drugs.

The five existing pregnancy-risk categories (A, B, C, D and X) will be condensed into three sections: Pregnancy (includes labor and delivery), Lactation (includes nursing mothers) and Females and Males of Reproductive Potential.

The Pregnancy section will include information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug. The Lactation section will provide information about using the drug while breastfeeding, and the Females and Males of Reproductive Potential section will include information, when necessary, about the need for pregnancy testing, contraception recommendations and information about infertility as it relates to the drug.

Effective June 30, 2015, applications for prescription drugs and biologics submitted to the FDA for approval will be required to include the new format, while labeling for drugs approved on or after June 30, 2001, will gradually be phased in. Labels for over-the-counter medicines will not change.

"Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk," said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child."

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