title: A review of safety-related pregnancy data surrounding the oral disease-modifying drugs for multiple sclerosis.
abstract: The recent approval of several oral disease-modifying drugs (DMDs) for multiple sclerosis (MS) brings promise of improved clinical effectiveness as well as greater drug compliance compared to the existing non-oral DMDs, and substantially increases patient choice and therapeutic options in the effective management of MS. However, for men and women with MS of childbearing age, concerns about the effect of oral DMDs on pregnancy and the fetus may arise. Some limited data from animal reproductive studies of oral DMDs suggest a potential increased risk of early pregnancy loss, impaired growth and birth defects. Although active surveillance mechanisms exist, there is limited data to inform clinical practice. Using existing information from published clinical trials and drug monographs, as well as recent conference proceedings, this review summarizes the mechanism of action (in relation to embryogenesis and pregnancy) and existing animal or human pregnancy-related data for approved (fingolimod, teriflunomide and dimethyl fumarate) and investigational (laquinimod and firategrast) oral DMDs for MS.
authors.affiliation: Division of Neurology, Brain Research Centre and Department of Medicine, Faculty of Medicine, University of British Columbia, Room S178, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada.
authors.forename: Ellen
authors.initials: E
authors.lastname: Lu
authors.forename: Bing Wei
authors.initials: BW
authors.lastname: Wang
authors.forename: Sura
authors.initials: S
authors.lastname: Alwan
authors.forename: Anne
authors.initials: A
authors.lastname: Synnes
authors.forename: Leanne
authors.initials: L
authors.lastname: Dahlgren
authors.forename: A Dessa
authors.initials: AD
authors.lastname: Sadovnick
authors.forename: Helen
authors.initials: H
authors.lastname: Tremlett
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000284:Administration, Oral; D000818:Animals; D003437:Crotonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069462:Dimethyl Fumarate; D005260:Female; D000068876:Fingolimod Hydrochloride; D005650:Fumarates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D006885:Hydroxybutyrates; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009570:Nitriles; D011247:Pregnancy; D011256:Pregnancy Outcome; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced* / Q000453:epidemiology; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013110:Sphingosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D014052:Toluidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D003437:Crotonates; D005650:Fumarates; D006885:Hydroxybutyrates; D007155:Immunologic Factors; D009570:Nitriles; D011409:Propylene Glycols; D014052:Toluidines; C527525:teriflunomide; D000069462:Dimethyl Fumarate; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine