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Pregnancy outcome in women exposed to leflunomide before or during pregnancy

  1. M Cassina1,
  2. DL Johnson2,
  3. LK Robinson3,
  4. SR Braddock4,
  5. R Xu2,
  6. J Lopez-Jimenez2,
  7. N Mirrasoul2,
  8. E Salas2,
  9. YJ Luo2,
  10. KL Jones2,
  11. CD Chambersand2,†,*,
  12. the Organization of Teratology Information Specialists Collaborative Research Group‡

DOI: 10.1002/art.34419

Additional Information

Author Information

  1. 1

    University of Padua, Padua, Italy

  2. 2

    University of California, San Diego, La Jolla, CA

  3. 3

    University of Buffalo, Buffalo, NY

  4. 4

    St. Louis University, St. Louis, MO

  1. †

    Ph: 619-294-3791 Fax: 619-220-0228

  2. ‡

    Collaborators: D Quinn, S Riordan, K Kao, J Brochu, S LaVigne, E Conover, M Roth, R Miller, L Wolfe, J Carey, J Robertson, N Djokanovic, G Koren, G Briggs, J Polifka, SH Lamm, OP Soldin, A Berard

*Department of Pediatrics, University of California, San Diego, 9500 Gilman Drive, MC 0828, La Jolla, CA 92093

Publication History

  1. Accepted manuscript online: 3 FEB 2012 02:38PM EST
  2. Manuscript Accepted: 31 JAN 2012
  3. Manuscript Revised: 4 JAN 2012
  4. Manuscript Received: 4 SEP 2011

Funded by

  • Sanofi-Aventis

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Keywords:

  • leflunomide;
  • pregnancy;
  • birth defects;
  • epidemiology

Abstract

Objective: Animal studies suggest that leflunomide may be a human teratogen. The only published human cohort study did not detect an increase in adverse outcomes in pregnancies exposed to leflunomide. The aim of this analysis was to expand on the previously published data with a description of birth outcomes among women who did not meet the cohort study criteria but who were exposed to leflunomide in pregnancy or were exposed only prior to pregnancy.

Methods: Data on pregnancy exposures and outcomes were collected from 45 pregnant women who contacted Teratology Information Services in the U.S. or Canada between 1999 and 2009. Sixteen women were exposed to leflunomide during the first trimester of pregnancy and 29 women were exposed only prior to conception.

Results: All 16 of the pregnancies exposed during pregnancy and 27 (93%) pregnancies exposed only prior to conception resulted in live born infants. There were two infants with major malformations among those exposed during pregnancy and no malformations reported in the preconception group. There was a potential known alternative etiology for at least some of the defects observed.

Conclusion: These data provide additional reassurance to women who inadvertently become pregnant while taking leflunomide and who undergo the washout procedure, and women who discontinue the medication prior to conception but have no pre-pregnancy documentation of drug clearance. However, until more conclusive data become available, women on therapy should be advised to use contraceptive methods and avoid pregnancy.

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