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Teratogen Update: Reproductive Risks of Leflunomide (Arava™); a Pyrimidine Synthesis - page 17 / 21





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that are present in the rodent that result in teratogenicity.  Regardless of this theoretical possibility, the conservative approach is to assume that therapeutic doses of leflunomide have teratogenic potential in the human.

Most of the women who became pregnant were ostensibly using contraception.  But apparently, there were contraceptive failures.  In a number of instances. the women had considered themselves infertile and had been suffering form RA for many years.  The dramatic improvement in their clinical condition was concomitantly associated with a return to fertility.  It is difficult to determine the prevalence of this phenomenon. If it is prevalent, then the rheumatologists who prescribe leflunomide, will have to reinforce the importance of contraception in women who may consider themselves to be infertile.

D. Clinical Presentations:

It should be pointed out that in every consultation with pregnant women taking AravaTM , the physician had counseled the patient to use contraception and that pregnancy represented a teratogenic risk.  In every instance cholestyramine therapy had been initiated on the day of the positive pregnancy test or within a few days following the diagnosis of pregnancy.  No one could have been aware of the fact that a number of women with severe  RA considered themselves to be infertile and may not have been concerned about their need for contraception.   I t may be that oral contraceptives plus a condom may be a more appropriate  method of contraception..  From the counseling standpoint, most rheumatologists would call with a meager knowledge of the pregnancy, i.e., not having available the LMP, date of conception, family size, patients name and age.  In many instance contact was made with the obstetrician, or family to gather important information for the purpose of  counseling the mother and family.

1.  Typical Case of an Unplanned  Pregnancy: These mothers suspected that they were pregnant  or a pregnancy test was positive some time during the week after the missed menstrual period

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