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Pregnancy Registries for MS Medications

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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

Avonex® Registry -- COMPLETED (Final results reported here.)

Betaseron® Registry -- COMPLETED (Final results reported here.)

Rebif® Registry -- COMPLETED (Final results reported here.)

Tysabri® Registry -- COMPLETED (Final results reported here.)

Aubagio® Registry -- Although Aubagio is not approved for use in pregnancy, a registry has been established to monitor pregnancy and infant outcomes of pregnant women exposed to Aubagio. Physicians are encouraged to enroll pregnant women in the Aubagio pregnancy registry, or women can enroll themselves by calling  1-877-311-8972 or visiting the Aubagio pregnancy registry website. Read interim results here.

Gilenya® -- Although Gilenya is not approved for use in pregnancy, a registry has been established to monitor pregnancy and infant outcomes of pregnant women exposed to Gilenya. Physicians are encouraged to enroll pregnant women in the Gilenya pregnancy registry, or women can enroll themselves by calling 1-877-598-7237 or visiting the Gilenya pregnancy registry website.

Lemtrada® Registry -- Although Lemtrada is not approved for use in pregnancy, a registry has been established to monitor pregnancy and infant outcomes of pregnant women exposed to Lemtrada. Physicians are encouraged to enroll pregnant women in the Lemtrada pregnancy registry, or women can enroll themselves by calling 1-866-758-2990 or emailing pregnancyregistries@increasearch.com.

Plegridy® Registry ‐‐ Although Plegridy is not approved for use in pregnancy, a registry has been established to monitor pregnancy and infant outcomes of pregnant women exposed to Plegridy. Physicians are encouraged to enroll pregnant women in the Plegridy pregnancy registry, or women can enroll themselves by calling 1‐866‐810‐1462 or visiting the Plegridy pregnancy registry website.

Tecfidera® Registry -- Although Tecfidera is not approved for use in pregnancy, a registry has been established to monitor pregnancy and infant outcomes of pregnant women exposed to Tecfidera. Physicians are encouraged to enroll pregnant women in the Tecfidera pregnancy registry, or women can enroll themselves by calling 1-866-810-1462 or visiting the Tecfidera pregnancy registry website.

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