Question
I am a 35 year old woman & I take a 40 ml Humira Injection 2x a month. My husband and I are ready to start our family. I am scheduled to have a pre-conception consultation with my OB, but have been referred to a perinatologist. I see there is very little information on Humira & Pregnancy. I did note that Humira falls into the FDA’s Pregnancy category B. Can you give me an idea of what risks Humira poses during conception and pregnancy? Are their any clincial trials I might be able to participate in?
Answer
Unfortunately, you are right that there is very little information on Humira or the other TNF inhibitors in pregnancy. To date, the studies with limited numbers of patients (most of whom took the drugs while unknowingly pregnant) have not shown any birth defects. There is also a small group of patients with severe Crohn’s colitis that took Remicade during pregancy without problems. The is a study coordinated by the Univ of California San diego that is collecting information on such patients. There will never be a formal clinical trial of these agents in pregnancy because of ethical considerations.
Most, including myself stop these drugs during pregnancy. Understandably, no one wants to take any risk.