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Mycophenolic acid and pregnancy: genotoxicity, malformations, spontaneous abortions

FEATURED REVIEW Mycophenolic acid is used as an immunosuppressant to prevent graft rejection after certain types of organ transplant. What is known as of mid-2022 about the possible harms to children of in-utero exposure to this drug?
Full review (4 pages) available for download by subscribers.

  • Mycophenolic acid is a cytotoxic drug with genotoxic and clastogenic properties. It is an immunosuppressant used to prevent graft rejection after certain types of organ transplant. Mycophenolate mofetil is rapidly metabolised to mycophenolic acid in the body.
     
  • About 50% of pregnancies exposed to mycophenolic acid during the first trimester end in spontaneous abortion. When the pregnancy continues, about 25% of the newborns have major malformations.

  • Studies on paternal exposure have not ruled out a potential genotoxic effect on spermatozoa.
     
  • In practice, given the risk of damage to gametes, it would be prudent for women to continue using effective contraception for at least 6 months after stopping treatment with mycophenolic acid before considering starting a pregnancy, and for men to do so for about 3 months. The alternatives come with a degree of uncertainty that must be handled on a case-by-case basis, with the involvement of the woman and couple concerned. 

Full text available for download below.

©Prescrire 1 September 2022

Source: "Mycophenolic acid and pregnancy: genotoxicity, malformations, spontaneous abortions" Prescrire International 2022; 31 (240): 210-213. Subscribers only.

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