This blog features:
- An overview of critical safety considerations related to pregnancy and lactation
- Key differences in case assessment between pregnancy and lactation scenarios
- MedDRA coding conventions for accurate and consistent case processing
Table of Contents
Introduction
Pregnancy- and lactation-related cases are among the most sensitive and frequently misinterpreted scenarios in pharmacovigilance case processing. Even experienced case processors can face uncertainty due to overlapping exposures, timelines, and patient involvement.
Are pregnancy and lactation part of the same category, or do they require distinct assessment approaches?
Understanding where they differ—and where they overlap—is critical for accurate case classification, coding, and regulatory compliance.
Let’s break it down.
Distinct between two: An overview
Pregnancy-Related Cases
Pregnancy-related cases involve exposure to a medicinal product before or during pregnancy and may affect multiple individuals. These cases are broadly classified as:
- Maternal exposure
- Paternal exposure
- Prospective cases (reported before outcome is known)
- Retrospective cases (reported after outcome has occurred)
The individuals potentially involved include:
- The mother
- The father
- The fetus or newborn (often referred to as a baby case)
Each category has unique regulatory and medical implications, making accurate identification essential.
Lactation (Breastfeeding) Cases
Lactation cases are closely related to pregnancy but represent a distinct exposure pathway. In these cases, drug exposure occurs through breastfeeding, rather than in utero.
Key characteristics include:
- The mother is administered a medicinal product during the lactation period
- The infant may be exposed to the drug via breast milk
- Adverse outcomes may be observed in either the mother or the infant
Even when the infant is not directly administered the drug, secondary exposure through lactation must be carefully evaluated.
“When drug exposure involves both mother and child, precision in pharmacovigilance is not optional—it is essential.”
The Common Thread: Drug Exposure and Safety Outcomes
Both pregnancy and lactation cases revolve around exposure to medicinal products during critical developmental periods. Any abnormal outcome, suspected adverse reaction, or safety concern—whether observed in the mother, fetus, or infant—requires thorough assessment, accurate classification, and regulatory reporting.
Understanding these distinctions ensures better case quality, improved signal detection, and enhanced patient safety.
Assessing Cases From Reports
These reports primarily include:
- Congenital anomalies or developmental delays observed in the fetus or child
- Fetal death, including spontaneous abortion
- Suspected adverse reactions in neonates that are classified as serious
- Infants affected due to exposure during lactation, where the medicinal product is suspected to be the cause
Note:
Certain pregnancy-related reports should not be submitted as Individual Case Safety Reports (ICSRs) because they do not involve a suspected adverse reaction. These include:
- Reports of induced termination of pregnancy without evidence of congenital malformation
- Reports of pregnancy exposure without outcome data
- Reports with a normal pregnancy outcome
Although these cases are not eligible for ICSR submission, they must still be collected, evaluated, and discussed in Periodic Safety Update Reports (PSURs) to ensure comprehensive safety monitoring.
Conditions are:
- pharmacovigilance for medicines exposed via breastfeeding should be followed.
- Suspected adverse reactions which occur in infants following exposure to a medicinal product from breast milk should be submitted in accordance with the criteria
- Baby doesnot have an indivual case until exposed via pregnancy or lactation
MedDRA Coding Conventions
These terms are used to describe drug exposure scenarios, where a medicinal product is transferred from one individual to another, potentially leading to safety concerns.
When selecting MedDRA terms, the following exposure scenarios should be considered based on the source information:
- Paternal drug exposure
Use this term when the father is exposed to a medicinal product and pregnancy confirmed with his partner after started taking the drug. - Maternal drug exposure
Use this term when the mother is exposed to a medicinal product during pregnancy via his spouse or her own medication. - Drug exposure via breast milk
Use this term when the infant is exposed to a medicinal product through breastfeeding during the lactation period. - Lactation (current condition)
Lactation period of the mother refers to the current condition of the mother, where she is breastfeeding at the time of the report, as in mother case.
Key Takeaways
- Pregnancy and lactation cases are classified as special safety monitoring scenarios, requiring enhanced attention due to their potential impact on both the mother and the child.
- Potential risks to the breastfed infant must be carefully evaluated and communicated, while also considering the well-established benefits of breastfeeding, provided breastfeeding is not contraindicated.
- Both pregnancy and lactation monitoring support the objective of effective risk-minimisation measures, ensuring informed clinical decision-making and improved patient safety.
Stay informed. Stay vigilant.
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Conclusion
In pharmacovigilance, pregnancy and lactation cases are never just another report—they represent critical moments where accurate assessment, precise coding, and informed risk evaluation directly influence patient safety. Clear differentiation and consistent monitoring are essential to ensure that both maternal and infant risks are identified, managed, and minimized effectively.
Do you feel any crucial points missing in the above write-up, feel free to comment.
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