Table 11: U.S. Food and Drug Administration Information that will be in the Pregnancy and Lactation Labeling Rule (PLLR) Section for Pregnancy and Lactation General Information Risks Clinical Considerations Background Data Pregnancy Inclusion of statement on background risk. Contact information about scientifically acceptable pregnancy registries. • Fetal Risk Summary: Information from all relevant sources. • Statement on inadvertent exposure in early pregnancy or notation no data is available.
• Include study type, dose, duration, timing, and results including fetal abnormalities or other adverse effects. • Human data are presented first, including positive
• Risk conclusion regarding developmental abnormalities in humans and other relevant risks: whether likely drug increases risk or not. • If increased risk identified by human data, a narrative will be included. • If data demonstrate drug is not systemically absorbed, a statement is included that maternal use is not expected to result in fetal exposure. • When drug is systematically absorbed, statements of risk are divided based on type of data, human or animal, with findings from human studies presented first.
• Description of any known risk to woman or fetus from the untreated disease. • Dosing adjustments during pregnancy. • Maternal adverse effects of drug unique or increased during pregnancy. • Effects of dose, timing, and duration of treatment with drug during pregnancy. • Potential neonatal complications and interventions needed. • If drug potentially used during intrapartum, even if not an FDA-approved indication, information will be included about effects on woman, fetus, or newborn; duration of labor and birth; risk of complications including need for interventions and long-term potential effects on the child.
and negative effects, number of subjects, and study duration. includes species involved and recalculation of doses into human dose equivalents.
• Animal study
Lactation General information is not mandated in rule.
• Risk Summary: Information from all relevant sources is included and identified. • Statement that drug is compatible with breastfeeding if no effect on quality of milk, quantity of milk; if nondetectable in milk; or no adverse effects found with child. • As applicable, a summary of the drug and effect on milk production, presence in milk, and effects on child will be included.
• Label will provide the following information, when available:
• Overview of the data that are the basis of Risk Summary and Clinical Considerations. • Human data to be presented first.
▪ Strategies to minimize exposure to the child, including topical drugs
to nipple; information about potential drug effects that could be useful to caregivers, such as monitoring for adverse effects, how to respond when they occur; and information about adjustments of maternal doses.
Females and Males of Reproductive Potential
• Risks are not specially noted as part of Females and Males of Reproductive Potential, but the following address when it must be included and imply risks: ▪ When pregnancy testing and/ or contraception are required or recommended before, during, or after drug therapy and/or ▪ When there are human and/or animal data that suggest drug-associated fertility effects. • Clinical considerations are not specifically noted as part of Females and Males of Reproductive. • Potential, but the following list content of potential clinical importance must be included, in order: ▪ Pregnancy testing. ▪ Contraception. ▪ Infertility. Note . U.S. Food and Drug Administration (2016). Pregnancy and lactation labeling final rule [online]. Retrieved from: https://www.gpo.gov/fdsys/ pkg/CFR-2016-title21-vol4/xml/CFR-2016-title21-vol4-sec201-57.xml.
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