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The Safety of Paternal Exposure to DMARDs and Biologics

Pregnancy and drug safety is a complex issue, often with limited informatoin about maternal drug exposure on the offspring. Greater uncertainty exists when considering whether paternal exposure may also influence fetal outcomes.

A systematic review examined the effect of disease modifying anti-rheumatic drugs (DMARDs) on male fertility and if peri-conception (within 3 months) paternal exposure was detrimental to fetal outcomes.

A literature search up to September 2017, identified 233 potentially relevant papers; 84 papers were included in the final analysis.

Available data on over 611 male DMARD exposures and over 5986 pregnancies conceived during paternal exposure demonstrated the following findings:

  • As was previously shown, cyclophosphamide and sulfasalazine significantly effected spermatogenesis
  • Biologic exposures (to anti-TNF therapies, abatacept, rituximab) demonstrated no hazard for fertility or pregnancy outcomes
  • DMARD exposures (azathioprine, cyclosporine A, hydroxychloroquine, leflunomide, methotrexate or mycophenolate mofetil) also did not effect fertility or pregnancy outcomes.
  • Inconclusive: no conclusions can be drawn on the following agents, largely for a lack of data - IVIG, tacrolimus, golimumab, anakinra or belimumab.

Treatment with these agents in men was not associated with impaired fertility. Moreover, treatment with the above noted agents appears to be safe for those men who are trying to conceive or those who are involved in accidental conception.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

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