Thursday, April 17, 2014

Fingolimod and birth defects

Karlsson G, Francis G, Koren G, et al. Pregnancy outcomes in the clinical development of fingolimod in multiple sclerosis.  Neurology 2014; 82: 674-680
and editorial Langer-Gould AM.  The pill times 2:  What every woman with multiple sclerosis should know.  Neurology 2914; 82: 654-5.
FDA required a pregnancy registry with approval of new MS drugs, including fingolimod.  66 women in clinical trials had unplanned pregnanies.  20 had elective abortions, 41 attempted to carry to term, of which 26 had healthy appearing babies, 9 had spontaneous abortions in first trimester,  4 pregnancies were terminated due to fetal abnormalities and 2 were born with major malformations including tetralogy of Fallot, failure of development and acrania.
Authors note that new orals (unlike monoclonals and first generation platform drugs) are small molecules that cross the placenta readily.