New Data Published on Safety of Leflunomide in Pregnancy

Data provide some reassurance to women exposed to leflunomide before or during pregnancy

WEDNESDAY, Feb. 15 (HealthDay News) -- New data on birth outcomes provide some reassurance to women who are inadvertently exposed to leflunomide before or during pregnancy, according to research published online Feb. 3 in Arthritis & Rheumatism.

To examine birth outcomes, Matteo Cassina, M.D., of the University of Padua in Italy, and colleagues collected data from 16 women exposed to leflunomide during the first trimester, and 29 women exposed prior to conception, who contacted Teratology Information Services in the United States or Canada.

The researchers found that 27 (93 percent) of the women who were exposed to leflunomide prior to conception, and all 16 of the women exposed to leflunomide during their first trimester, had live born infants. In the women exposed during pregnancy, there were two infants with major malformations, but no malformations occurred in women exposed prior to conception. Potential alternative causes of the malformations were available for at least some of defects observed.

"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," the authors write.

The study was funded by Sanofi-Aventis, which manufactures leflunomide.

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