Table 10: U.S. Food and Drug Administration Information That is in the Pregnancy and Lactation Labeling Rule (PLLR) Section General Information Risks Clinical Considerations Background Data
Pregnancy Inclusion of statement on background risk.
• Fetal Risk Summary: Information from all relevant sources. • 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. • 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.
• Statement on inadvertent exposure in early pregnancy or notation no data is available. • 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.
• Include study type, dose, duration, timing, and results including fetal abnormalities or other adverse effects. • Human data is presented first, including positive and negative effects, number of subjects, and study duration. • Animal study includes species
Contact information about scientifically
acceptable pregnancy registries.
involved and recalculation of doses into human dose equivalents.
Lactation General information is not mandated in rule.
• Label will provide the following information, when available: ○ Strategies to minimize
• Overview of the data that are the basis of Risk Summary and Clinical Considerations. • Human data to be presented first.
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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