Yearly in the United States, more than 6 million pregnancies occur, and women take an average of 3 to 5 prescription drugs during pregnancy.Women may be taking essential medications for preexisting medical conditions such as hypertension or asthma, which they need to continue taking during pregnancy and breastfeeding. Some women may need to take medications for acute or new conditions that may occur during pregnancy or breastfeeding. About 2% to 3% of all birth defects result from drugs used to treat a disorder or symptom. Thus the recently published final rule from the FDA referred to as the “Pregnancy and Lactation Labeling Rule,” is important to pregnant women, healthcare professionals, and all drug manufacturers.
This final rule is scheduled to take effect on June 30, 2015, and affects all drug labels: it sets new standards for how pregnancy and lactation information is presented in package inserts of new and existing drugs and biologic products. These changes were made from the previous letter-based categorization system (A, B, C, D, and X) because that system oversimplified the classification of risk during pregnancy and overshadowed individualized prescribing decisions that involve complex maternal, fetal, and infant risk-benefit considerations, according to Sandra Kweder, MD, Deputy Director of the Office of New Drugs in the FDA Center for Drug Evaluation and Research.
The new content and formatting requirements will provide a consistent format to present the risks and benefits of drugs and biologics used by women during pregnancy and lactation and by both women and men of reproductive potential. The new labeling requires 3 subsections titled “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” The “Pregnancy” subsection will address use of the drug during pregnancy (ie, dosing and potential risks to the developing fetus) and will be required to include registry information, if it exists, that maintains data on how the drug or biologic affects pregnant women. Information about use of the drug during breastfeeding will be given in the “Lactation” subsection, which will review the amount of the drug excreted in breast milk and possible effects on the breastfed infant. The “Females and Males of Reproductive Potential” subsection will provide information on requirements or recommendations for pregnancy testing and contraception as they relate to the drug, and on potential effects of the drug on fertility. This information had been included in labeling previously but without specifically designated placement until this ruling.
Each of these 3 detailed subsections must include summaries of the risks associated with the use of the drug during breastfeeding and pregnancy (under the subheading “Risk Summary”), a discussion of supporting data (under the subheading “Data”), and information relevant to assist the prescriber in making prescription-related and counseling decisions (under the subheading “Clinical Considerations”). Under these subheadings will be provided more detailed information on topics such as human and animal data relating to the drug and specific adverse reactions of particular concern to pregnant or breastfeeding women.
To read the official FDA announcement, go to http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm.
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