Monday, 25 May 2015

ClinicSpeak: pregnancy ouctomes on teriflunomide

Teriflunomide and falling pregnant: what are the consequences? #ClinicSpeak #MSBlog #MSResearch

"The following paper reports pregnancy outcomes of MSers on Teriflunomide (Aubagio). There are far too few pregnancies to change clinical practice, except maybe not to recommend elective termination of pregnancy in someone who falls pregnant accidently on teriflunomide. A more measured approach would be to stop teriflunomide, instituting a rapid washout of the drug with cholestyramine and a referral to a foetal medicine expert to make sure there are no obvious fetal abnormalities. Once all the relevant information is on the table a rational discussion can take place on how to take things forward. Not all accidental pregnancies are unwanted and the MSer concerned and her partner will need to decide on how to take things further. Despite its category X label teriflunomide is clearly not as teratogenic as label suggests."


"The following is the summary of product characteristics for teriflunomide."


Kieseier BC, Benamor M.Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis. Neurol Ther. 2014 Nov 20;3(2):133-8. doi: 10.1007/s40120-014-0020-y

INTRODUCTION: Teriflunomide, indicated for the treatment of relapsing-remitting multiple sclerosis, is contraindicated in pregnancy based on signs of developmental toxicity in the offspring of rats and rabbits; developmental toxicity has also been observed in preclinical studies of other disease-modifying therapies. Despite the requirement to use reliable contraception in clinical trials evaluating the safety and efficacy of teriflunomide, a number of pregnancies have been reported. This work reports pregnancy outcomes in teriflunomide clinical trials.

METHODS: Pregnancy outcomes were evaluated in a retrospective analysis of the global pharmacovigilance database. The following information was collected from the pharmacovigilance database or individual patient files: treatment allocation, pregnancy outcome, teriflunomide exposure, and use of the accelerated elimination procedure.

RESULTS: At data cut-off, 83 pregnancies were reported in female patients and 22 pregnancies were documented in partners of male patients. All newborns were healthy and did not have any structural or functional abnormalities at birth.

CONCLUSION: Available data do not indicate any teratogenic signals in patients treated with teriflunomide.

CoI: multiple

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