Teratogenicity: analysis of European risk management plan summaries.

Teratogenicity risk: content analysis of European risk management plan summaries

  • Kalindi Hapani Not applicable
Keywords: Safety concerns, additional risk minimisation measures, Summary of product characteristics, Important identified risk, Important potential risk, Missing information


Background: A judicious decision is significant in clinical practice when a known teratogenic medicine is prescribed for women considering her ailment or avoiding its exposure due to foetal harm. For this careful balance, European medicine agency (EMA) and marketing authorization holder provides complete pharmacological information regarding each medicinal product for clinicians to take informed decision. Proactively, EMA publishes the safety concerns included in the risk management plan (RMP) and subsequent risk minimisation measures.

Objectives: The objective of present study is to review safety information published in RMP summaries for teratogenic medicines and to explore the proactive approaches considered to improve its benefit-risk balance.

Method: All safety concerns (SC) included in the RMPs of originator centrally authorised products (CAPs), authorised between 1 August 2012 and 31 December 2022, were collected from the European Public Assessment Report. Teratogenicity SCs were categorized by Anatomical Therapeutic Classification code, year of authorisation, category of safety concern and type of risk minimisation measures. Further, Summary of Product Characteristics (SmPC) were reviewed for safety information. 

Results: During the study period, 324 CAPs were found to be associated with teratogenicity SC. Antineoplastic and immunomodulating agents had teratogenicity SCs most often. Out of 324 CAPs, 221 product SCs were categorized as missing information. Twenty-nine products had additional risk minimisation measures (aRMMs) which addressed teratogenicity SC. These aRMMs consisted of educational program, controlled distribution system and pregnancy prevention program targeted towards healthcare professionals and/or patients. Further, 155 additional pharmacovigilance activities were identified in these product RMP summaries for teratogenicity risk. Content analysis of SmPC revealed that important information on the use of medicines during pregnancy is missing.

Conclusion: More than half of the RMP summaries described teratogenicity as SC for the medicines approved during the study period. Post-authorization data on teratogenic medication should be actively collected and ensured to reach the clinicians via SmPC and/or aRMMs to keep them updated and enhance evidence-based decision making.


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How to Cite
Hapani K. Teratogenicity: analysis of European risk management plan summaries. jpadr [Internet]. 2023Sep.1 [cited 2023Dec.10];4(3):25-3. Available from: https://jpadr.com/index.php/jpadr/article/view/133