Copaxone Now Approved for Use During Pregnancy and Breastfeeding After Decades of Safety Data

Teva has updated the prescribing guidelines for Copaxone, a medication used to treat relapsing-remitting multiple sclerosis (RRMS). The revised information now allows for its use during pregnancy and breastfeeding when clinically necessary. The decision follows years of data collection and safety assessments involving hundreds of pregnancies.

Copaxone, an immunomodulator, has been studied in pregnant women for decades. A 2016 analysis of 618 pregnancies from 1997 to 2020 found no safety concerns compared to the general population. No increase in birth defects, preterm births, or cesarean deliveries was observed when the drug was taken in the first trimester.

Global pharmacovigilance data, covering 2,455 reported pregnancies with known outcomes, also showed no risks to pregnancy progression or neonatal health. While earlier registries, such as the Teva Copaxone Pregnancy Registry (closed in 2013), documented around 700 exposures, long-term child safety data beyond infancy remains limited. Existing studies, including FDA reviews and ECTRIMS assessments, have not identified major teratogenic risks, but experts call for more prospective registries to track long-term effects.

The updated guidance now permits 'bridging'—continuing Copaxone until conception—to avoid treatment gaps. Women with high disease activity during pregnancy may also keep using the drug after a risk-benefit evaluation. Additionally, the new label confirms that Copaxone can be safely administered while breastfeeding, ensuring uninterrupted therapy.

The revised prescribing information states that extensive data, including over 1,000 pregnancy outcomes, shows no increased risk of birth defects or fetal harm. Clinicians can now consider Copaxone for pregnant and breastfeeding patients when necessary. The changes aim to provide clearer guidance while addressing gaps in long-term pediatric follow-up.