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FDA issues rule on changes to pregnancy and lactation labeling for prescription drugs

Women who are pregnant or breast-feeding and need to take prescription medications soon will see more detailed information regarding their prescriptions specifically for them on drug labels. The U.S. Food and Drug Administration published a final rule Dec. 3 that sets standards for how information about using medicines during pregnancy and breast-feeding is presented in the labeling of prescription drugs and biological products, according to a news release. The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks for pregnant or breastfeeding women.

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” Sandra Kweder, MD, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. 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.”

There are over 6 million pregnancies in the U.S. every year, and pregnant women take an average of three to five prescription drugs during pregnancy, according to the release. Women with pre-existing medical conditions may need to continue to use prescription drugs to treat those conditions during pregnancy and breast-feeding, while women also may need to take medications for new or acute conditions that occur during pregnancy or breast-feeding. The new labeling format and requirements reorganizes information and is structured to help inform healthcare professionals’ prescribing decisions and the counseling of patients using prescription drugs.

The final rule requires the use of three detailed subsections in the labeling titled Pregnancy, Lactation and Females and Males of Reproductive Potential that must include a summary of the risks of using a drug during pregnancy and breast-feeding, a discussion of the data supporting the summary and relevant information to help healthcare providers make prescribing and counseling decisions.

• The Pregnancy subsection will include dosing and potential risks to the developing fetus and information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug or biological product.
• The Lactation subsection will provide information such as the amount of drug in breast milk and potential effects on the breast-fed child.
• The Females and Males of Reproductive Potential subsection will include information about pregnancy testing, contraception and infertility as it relates to the drug.

The Pregnancy and Lactation subsections will also include three subheadings — risk summary, clinical considerations and data. These subheadings will provide more detailed information regarding, for example, human and animal data on the use of the drug and specific adverse reactions of concern for pregnant or breast-feeding women.
The rule will be effective June 30, 2015.

By | 2014-12-10T00:00:00-05:00 December 10th, 2014|Categories: National|0 Comments

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