Related Experiment Video
Updated: Jun 7, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Prenatal exposure to mycophenolate mofetil: an updated estimate
Chagit Klieger-Grossmann1, David Chitayat, Sharon Lavign
1Motherisk Program, The Hospital for Sick Children, Toronto ON, Canada.
Abstract:
Mycophenolate mofetil (MMF) has become a major therapeutic option in the management of patients undergoing transplantation, as well as in the treatment of autoimmune conditions. Case reports have suggested that MMF use during pregnancy is associated with a specific pattern of congenital malformations. Because many pregnancies are unplanned, it is imperative to assess the teratogenic risk of MMF. Using the Organization of Teratology Information Specialists network, we prospectively identified and followed pregnant women exposed to MMF during pregnancy to update this teratogenic potential. Ten cases were identified and all received the drug during embryogenesis at the recommended doses (500 to 1500 mg daily). There were four miscarriages and one elective abortion due to fear of teratogenesis. None of the five live births had malformations. It is possible that, similar to other human teratogens discovered first by case reports, the absolute risk from MMF may be smaller than originally calculated based on case reports. Because the major malformations phenotypic of MMF may be visualized in utero (e.g., microtia, cleft palate, congenital diaphragmatic hernia, and cardiac malformation), diagnostic imaging should be performed.
Insights
Mycophenolate mofetil (MMF) use in pregnancy may pose risks, but prospective data suggests the absolute teratogenic risk might be lower than previously thought. Close monitoring and diagnostic imaging are recommended for exposed pregnancies.
Area of Science:
- Pharmacology
- Teratology
- Reproductive Medicine
Background:
- Mycophenolate mofetil (MMF) is a key immunosuppressant for transplant recipients and autoimmune diseases.
- Case reports indicate MMF exposure during pregnancy may cause congenital malformations.
- Unplanned pregnancies necessitate a clear understanding of MMF's teratogenic potential.
Purpose of the Study:
- To prospectively evaluate the teratogenic risk of Mycophenolate mofetil (MMF) exposure during pregnancy.
- To update the understanding of MMF's safety profile in pregnant women.
Main Methods:
- Prospective cohort study utilizing the Organization of Teratology Information Specialists (OTIS) network.
- Identification and follow-up of pregnant women exposed to MMF during embryogenesis.
- Data collection on pregnancy outcomes, including malformations in live births.
Main Results:
- Ten pregnancies exposed to MMF during embryogenesis were identified.
- Four miscarriages and one elective abortion occurred.
- None of the five live births exhibited congenital malformations.
- The observed malformation rate may be lower than suggested by initial case reports.
Conclusions:
- The absolute teratogenic risk of Mycophenolate mofetil (MMF) may be lower than previously estimated from case reports.
- Specific MMF-associated malformations (e.g., microtia, cleft palate, cardiac defects) can potentially be detected via prenatal imaging.
- Diagnostic imaging is advised for pregnancies exposed to MMF to assess fetal development.
Related Concept Videos
Pharmacogenetics of Phase II Enzymes: N-acetyltransferase, Thiopurine S-methyltransferase, UDP-glucuronosyltransferase
Teratogenicity
Drug Toxicity: Risk factors
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Cryptococcal Meningitis
