Relationship Between Paternal Methotrexate Use and Congenital Malformations

congenital malformation
congenital malformation
No association was found between preconception paternal methotrexate use and major or all congenital malformations.

The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO — After a systematic review and analysis, researchers from Copenhagen University in Denmark found no link between preconception paternal methotrexate treatment and congenital malformations in offspring. The researchers presented their findings at the 2018 ACR/ARHP Annual Meeting held October 19-24, 2018, in Chicago.

The researchers pulled data from the PubMed, Embase, Cochrane Central, and CINAHL databases to study possible links between men using methotrexate and congenital malformations in offspring. They used 3 studies in their analysis, which included 265 fathers who had been exposed to methotrexate compared with more than 1 million fathers who had not been exposed.

Of the 265 methotrexate-exposed fathers, 13 of their children had malformations, of which 7 were major. Among the more than 1 million fathers not exposed to methotrexate, 50,576 of their children had malformations, of which 33,816 were major.

The odds ratios for major malformations was 1.02 (95% CI, 0.48-2.20). For all malformations, the odds ratios was 0.86 (95% CI, 0.48-1.54).

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The researchers found no association between methotrexate use in fathers and congenital malformations in their offspring. The researchers concluded, “there is no evidence supporting the current recommendations to avoid paternal [methotrexate] use before conception.”

For more coverage of ACR/ARHP 2018, click here.


Jensen TB, Christensen MB, Anderson JT. Paternal use of methotrexate (MTX) and congenital malformations – a systematic review and meta-analysis. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 1853.

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