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 is 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 is 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 is to identify the outcomes of these pregnancies, including miscarriages and birth defects.
As the information about each of these registries becomes available, we will provide you with materials from the pharmaceutical companies to share with your physician. The pharmaceutical companies will also be alerting physicians about the registries as they are developed.
To Share with Your Healthcare Provider
Avonex Registry
- Overview of Registry (.pdf)
Betaseron Registry
- Letter for Physician (.pdf)
Rebif Registry
- Letter for Physician (.pdf)