In the clinical trials of the three interferon beta medications now approved for the treatment of MS (Avonex®, Betaseron® and Rebif®) 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 interferon beta 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 three interferon medications is 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.
With the approval of natalizumab (Tysabri) in 2006 , the FDA required Biogen Idec and Elan Pharmaceuticals to create a similar kind of pregnancy registry.
Information about the registries is provided here, including materials from the pharmaceutical companies to share with your physician. The pharmaceutical companies also alert physicians about the registries as they are developed.
To Share with Your Healthcare Provider
Avonex Registry -- COMPLETED
Betaseron Registry
- Letter for Physician (.pdf)
Rebif Registry
- Letter for Physician (.pdf)
Tysabri Registry -- COMPLETED
Aubagio
Although Aubagio is contraindicated in pregnancy, a registry has been established to monitor fetal 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 1-800 745-4447, option 2.
Gilenya
A pregnancy registry has been established to collect information about the effect of Gilenya use during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the Gilenya pregnancy registry by calling 1-877-598-7237 or visiting www.gilenyapregnancyregistry.com.