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Tetrada of the possible mycophenolate mofetil embryopathy: a review

Paul Merlob1, Bracha Stahl, Gil Klinger

  • 1Beilinson Teratology Information Service, Petah Tiqwa, Israel. merlobp@post.tau.ac.il

Reproductive Toxicology (Elmsford, N.Y.)
|June 4, 2009
PubMed

Insights

Mycophenolate mofetil (MFM) use in pregnancy may lead to birth defects. This immunosuppressant drug is linked to a unique pattern of malformations in newborns, including ear, mouth, and eye abnormalities.

Area of Science:

  • Pharmacology
  • Teratology
  • Immunology

Background:

  • Mycophenolate mofetil (MFM) is an immunosuppressant used in transplantation and autoimmune diseases.
  • Animal studies suggest MFM can cause fetal resorption and malformations.
  • Limited human data exist on MFM use during pregnancy.

Purpose of the Study:

  • To investigate the potential teratogenic effects of Mycophenolate mofetil (MFM) in human pregnancies.
  • To describe the phenotype of infants exposed to MFM in utero.

Main Methods:

  • Review of 9 case reports, 1 case series, and 2 registry data on MFM exposure during pregnancy.
  • Analysis of structural anomalies in 12 newborns exposed to MFM.

Main Results:

  • A distinctive phenotype, termed EMFO tetrada (Ear, Mouth, Fingers, Ocular/Organ malformation), was observed.
  • Frequent anomalies included microtia, auditory canal atresia, cleft lip/palate, micrognathia, hypertelorism, and ocular coloboma.
  • MFM exposure was associated with these congenital malformations.

Conclusions:

  • Mycophenolate mofetil (MFM) may be a teratogenic drug.
  • The observed phenotype suggests a potential new embryopathy.
  • Recommendations are provided to prevent MFM-related embryopathy.

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The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...