Document Detail


Reviewing the evidence for mycophenolate mofetil as a new teratogen: case report and review of the literature.
MedLine Citation:
PMID:  19441125     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Mycophenolate mofetil (MMF) (CellCept) is an immunosuppressant drug that is teratogenic in rats and rabbits. Reports of malformations in 13 offspring of women exposed to MMF in pregnancy raise concern that MMF is also a human teratogen. We report an additional child with malformations following prenatal exposure to MMF and review the other 13 reports. We identified a Cambodian male born at 31 weeks' gestation to a mother who had been treated for lupus nephritis with MMF from before conception to 12 weeks' gestational age. He had bilateral moderate-to-severe microtia, external auditory canal atresia, bilateral conductive hearing loss, mild microcephaly, and apparently normal development. Among the 14 MMF-exposed offspring now reported, the underlying maternal conditions were kidney transplantation (7), lupus nephritis (4), liver transplantation (1), heart transplantation (1), and recurrent erythema multiforme (1). All were exposed in early pregnancy. The most distinctive malformation was moderate-to-severe microtia or anotia (12), with external auditory canal atresia in 9. Other common craniofacial malformations and minor anomalies included orofacial clefts (7), hypertelorism (3), coloboma (3), and micrognathia (3). Six had cardiovascular malformations, of which three were either conotruncal or aortic arch defects. MMF dose, reported in 12 patients, was <1 g/day in 4 and 1 g or more/day in 8; no correlation between dose and phenotype severity was apparent. While case reports have limited value in identifying human teratogens, the unusual distribution of malformations among the 14 reported exposed offspring identifies a phenotype suggesting that MMF is likely a human teratogen.
Authors:
Marlene T Anderka; Angela E Lin; Dianne N Abuelo; Allen A Mitchell; Sonja A Rasmussen
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Publication Detail:
Type:  Case Reports; Journal Article; Review    
Journal Detail:
Title:  American journal of medical genetics. Part A     Volume:  149A     ISSN:  1552-4833     ISO Abbreviation:  Am. J. Med. Genet. A     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-02     Completed Date:  2009-07-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101235741     Medline TA:  Am J Med Genet A     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1241-8     Citation Subset:  IM    
Copyright Information:
(c) 2009 Wiley-Liss, Inc.
Affiliation:
Massachusetts Department of Public Health, Massachusetts Center for Birth Defects Research and Prevention, Boston, MA 02108, USA. marlene.anderka@state.ma.us
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / etiology*
Abnormalities, Multiple / chemically induced*
Fatal Outcome
Female
Humans
Immunosuppressive Agents / administration & dosage,  adverse effects*
Maternal-Fetal Exchange
Mycophenolic Acid / administration & dosage,  adverse effects*
Pregnancy
Teratogens*
Young Adult
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Teratogens; 24280-93-1/Mycophenolic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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