The limited data from a few studies has not supported an increased chance of prematurity (birth before 37 weeks), or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) with the use of leflunomide during pregnancy
In order to address the safety of leflunomide in unintended exposures in pregnancy, we performed a critical review of human studies
Objective: In preclinical reproductive studies, leflunomide was found to be embryotoxic and teratogenic
In preclinical reproductive studies, leflunomide was found to be embryotoxic and teratogenic
However, its use is contraindicated in pregnancy
Oct 30, 2017 · tive Research Group conducted a pregnancy outcome prospec-tive cohort study to address the fetal safety of exposure to leflunomide for any length of time during
It found that 99
Since the drug has a prolonged and unpredictable e
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The registration studies for
Women treated with leflunomide are advised to avoid pregnancy; those who become pregnant are advised to reduce fetal exposure through a cholestyramine drug elimination procedure
Dobson R, et al
The available human data comprise a case-control study, a small prospective cohort study, and several case reports/series that collectively describe the outcomes of approximately 500 unique pregnancies exposed to leflunomide
3) embryo-lethality occurred in animal reproduction studies with leflunomide at doses lower than the human exposure level [see : Use in Specific Populations (8
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to therapy during pregnancy
Our studies are observational; people who are pregnant are not asked to take any medications or change their current treatments
Janssen is a Johnson & Johnson pharmaceutical company that produces guselkumab (Tremfya®), an interleukin-23 blocker indicated for the treatment
To minimize risk, men wishing to father a child should consider discontinuing leflunomide therapy and
The study authors
Based upon animal studies, leflunomide may increase the risk of fetal death or teratogenic effects when given to a pregnant patient
Controlling disease during pregnancy is vital and most medications are safe to use
Leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm