title: Tetrada of the possible mycophenolate mofetil embryopathy: a review.
abstract: Mycophenolate mofetil (MFM) is an immunosuppressant agent used in organ transplantation, rheumatoid arthritis and lupus nephritis. Experimental data show that doses roughly equivalent to those used clinically in transplant patients may cause fetal resorption and malformations in pregnant rats and rabbits. There are limited data regarding the use of MFM in pregnant women. The human experience is based on 9 case reports, 1 case series, and 2 registry data. The most frequent structural anomalies described in 12 newborns exposed to MFM were as follows: microtia (11); auditory canal atresia (8); cleft lip and palate (6); micrognathia (4); hypertelorism (4); ocular coloboma (3); short fingers (2) and hypoplasic nails (2). The distinctive and unique phenotype associated with MFM exposure during pregnancy (EMFO tetrada: Ear, Mouth, Fingers, Ocular/Organ malformation) raised the hypothesis that MFM may be a real teratogenic drug. Appropriate recommendations to prevent this possible new embryopathy are given.
authors.affiliation: Beilinson Teratology Information Service, Petah Tiqwa, Israel. merlobp@post.tau.ac.il
authors.forename: Paul
authors.initials: P
authors.lastname: Merlob
authors.forename: Bracha
authors.initials: B
authors.lastname: Stahl
authors.forename: Gil
authors.initials: G
authors.lastname: Klinger
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control; D000015:Abnormalities, Multiple / Q000139:chemically induced* / Q000473:pathology / Q000517:prevention & control; D000328:Adult; D000818:Animals; D003257:Consumer Product Safety; D004622:Embryo, Mammalian / Q000187:drug effects / Q000473:pathology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000633:toxicity*; D007231:Infant, Newborn; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000633:toxicity; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D012042:Registries; D018570:Risk Assessment; D013723:Teratogens / Q000493:pharmacokinetics / Q000633:toxicity*
chemical_list: D007166:Immunosuppressive Agents; D013723:Teratogens; D009173:Mycophenolic Acid