Bayer announced that the Food and Drug Administration (FDA) has approved a labeling update for Betaseron (interferon beta-1b) to include new safety data on pregnancy based on information collected from pregnancy exposure registries.
Betaseron, an immunomodulator, is indicated to reduce the frequency of clinical exacerbations of relapsing forms of multiple sclerosis (MS) in patients who have experienced a first clinical episode and have MRI features consistent with MS.
Data on the risk of interferon beta-1b use in women who were planning to become pregnant or were pregnant were collected from prospective observational studies and the Betaseron pharmacovigilance database. A similar rate of birth defects and spontaneous abortions (ie, miscarriage) was seen in pregnant women who were exposed to interferon beta-1b compared with the general worldwide population.
Based on these findings, the Pregnancy section in the Betaseron prescribing information has been updated to include, “Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy.”
Moreover, the Lactation section states that “The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Betaseron and any potential adverse effects on the breastfed child from Betaseron or from the underlying maternal condition.”
“We hope information included in the FDA label update will encourage discussion between physicians and their patients and provide answers for doctors to discuss with women who plan to start a family or who have a recently confirmed pregnancy,” said Mark Rametta, DO, FACOI, FACP, Medical Director, Neurology at Bayer.
Betaseron is available as 0.3mg per vial as a powder for subcutaneous (SC) injection after reconstitution.
For more information call (800) 288-8371 or visit Betaseron.com.