The Food and Drug Administration (FDA) has removed the category C warning from the package insert for interferon beta-1a (Rebif; EMD Serono, Rockland, MA). The change is based on the revised Pregnancy and Lactation Labeling Rule (PLLR) and new safety data that the FDA also approved for inclusion in the package insert.
This safety data and labeling change provide women taking interferon beta-1a to more confidently weigh the risks and benefits of continuing treatment of their multiple sclerosis (MS) while starting or continuing to grow their families. Although women should still notify and consult with their health care team if they become pregnant, there is no evidence that continuing to take interferon beta-1a would put the developing fetus at risk of birth defects.
The updated safety information is based on data from a study (NCT02749396) of 2,831 women and other published studies over several decades. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta in pregnancy have been inconsistent.
New data also show that interferon beta-1a is excreted in breast milk at low levels, giving healthcare providers and their patients more information to assist with medical decision making. There are no data on the effects of interferon beta-1a on milk production. Health benefits of breastfeeding should be considered along with the mother's clinical need for interferon beta and any potential adverse effects on the breastfed child from either the mother's MS or her treatment with interferon beta-1a.
"At EMD Serono, we are dedicated to supporting women with multiple sclerosis (MS) at every stage of their life journey, including when planning to start or expand their families," said Maria Rivas, MD, global chief medical officer, SVP, EMD Serono. "Today's update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives."
Maria Houtchens, MD, associate professor of Neurology, Brigham and Women's Hospital, Boston said, "The inclusion of pregnancy outcomes and lactation data in the interferon beta-1a label provides valuable insights. I believe it will encourage discussions between physicians and their patients about MS treatment options when considering pregnancy."
Barbara C. Jobst, MD
Stephanie Kazi, BS; Caleb Heiberger, BS; and Divyajot Sandhu, MD
Chen Zhao, MD; Jonathan G. Hakun, PhD; Krishnankutty Sathian, MBBS, PhD; and Nikolaos Scarmeas, MD, MS, PhD