Alcohol & Other Drugs: Prescription Medication

Q: I've been prescribed Arava for my arthritis and was told it casues severe birth defects and/or fetal death if I become pregnant on it, and that an abortion is mandatory. If I want to become pregant, I have to take another drug to get the Arava back out of my body. How long does it take to rid my system of the Arava to the point that it will be safe to have children? What is invloved in eliminating this drug from my body?

A: Although no adequate studies exist with Arava in human pregnancy (such studies would be unethical based on the experience with animals), animals studies suggest that there is a substantially increased risk for fetal death and/or teratogenic (birth) effects. FDA considers Arava to be a Category X drug, which means that studies in animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk to a fetus clearly outweighs any possible benefit the mother may get from it.

The protocol for Arava (Lefunomide) elimination calls for a woman who becomes pregnant while taking the drug to be withdrawn immediately upon the knowledge that she is pregnant. The other drug you mention that would facilitates Arava elimination is called cholestryramine. It would be prescribed at the level of 8 grams 3 times daily for 11 days, at which time a blood test would be done to verify that Arava has been successfully eliminated. The blood evidence is a serum level of an Arava metabolite should be below 0.02mg/L to be considered successful. This information comes directly from the Arava product literature and is dated 2001. -- Spot (May 1, 2003)