Information on Current and Completed Pregnancy Registries for MS Therapies
August 5, 2013
In the original clinical trials of the disease-modifying therapies now approved for the treatment of MS
women were required to use contraception during the trials and were discontinued from the trials if they became pregnant. As a result, there was little information on the effects of any of these medications on pregnancy. Since MS primarily affects women of childbearing age who can become pregnant unintentionally, it was considered extremely important to acquire information about how medications can affect pregnancy and unborn children.
In August 2002, the Food and Drug Administration issued guidelines requiring the manufacturers of these medications to develop pregnancy registries to monitor women who have taken one of these drugs within a week of becoming pregnant or while they were pregnant. Although none of the medications are approved for use during pregnancy, a woman may unintentionally become pregnant while on treatment. If the woman is unaware that she is pregnant, several weeks may pass before she stops the medication. The purpose of the registries has been to identify the outcomes of these pregnancies, including miscarriages and birth defects.
Information about the registries is provided here