Enbrel and potential birth defects ???

HI Shellie,

TNF inhibitors (Enbrel, REmicade and Humira) have been on the market now for 7-10 years.  Yet, we still don't know for sure whether they cause birth defects or not.  The reason is that there are so few women having babies while taking these drugs.  Most women with RA stop their medications during pregnancy.  Of those who continue them, there are too few to compare to non-RA women with any certainty. However, the data that do exist do not raise too many red flags.  In general, the percentage of miscarriages and birth defects in women on TNF inhibitors is pretty similar to the percentages in women not taking these drugs (and who don't have RA).  There have been a few reports of cleft palate in babies of mothers taking TNF inhibitors and 2 babies with signs of, but not the full blown syndrome called, VACTERL.   In animal studies, the TNF inhibitors do not cause miscarriages, birth defects or infertility.  In general, we advise stopping the drugs during pregnancy for women even though we do think they may be safe (but we just don't know).  For men, it is probably not necessary to stop the drug since so little of it would get to the fetus.