Copaxone appears safe for use in pregnancy, breastfeeding: Study
No link found to increased risks for children with approved MS medication
Treatment during pregnancy with the approved multiple sclerosis (MS) medication Copaxone (glatiramer acetate injection) does not appear to increase the risk of birth defects in infants, and its use while breastfeeding is not linked to growth problems in the youngsters, according to follow-up data of mothers and their children from over a four-year period.
In a long-term study of the therapy — which has been approved in the U.S. for more than two decades for treating relapsing forms of MS — Copaxone use by MS patients while pregnant or nursing was not linked to any greater risk of adverse events, or side effects, at either its 20 or 40 mg doses.
The researchers noted pregnancy outcomes “remained within normal ranges,” and growth rates for breastfed infants were “within normal limits.”
“Despite limitations of post-marketing data, this four-year study found no increased risk of adverse pregnancy, fetal, or infant outcomes associated with [Copaxone],” the teams wrote. “These findings support the safety of both 20 and 40 mg/mL [Copaxone] during pregnancy and breastfeeding.”
The study, “Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update,” was published in the journal Drug Safety. It was funded by Teva Pharmaceuticals, which markets Copaxone.
Copaxone one of few MS treatments considered safe to use in pregnancy
MS affects women about three times more often than men, and many are diagnosed during their childbearing years. Most disease-modifying therapies (DMTs) are not recommended during pregnancy or breastfeeding, making MS treatment more complex. Careful consideration is needed to balance the benefits of DMTs with potential risks to the pregnancy and the baby.
Copaxone is generally considered safe for use during pregnancy and breastfeeding and is among the few DMTs that should be considered during this period of time. However, according to the researchers, long-term data on its effects — “particularly for the 40 mg … dose,” are limited.
The therapy is approved in more than 50 countries worldwide. In the U.S., it’s indicated for adults with relapsing forms of MS, where symptoms flare up and then partially or fully resolve. The medication comes as a single-dose prefilled syringe for injection under the skin, at 20 or 40 mg/mL, with generic versions also available.
To collect more data on the safety of Copaxone during pregnancy and breastfeeding, researchers at Teva drew on the company’s pharmacovigilance database. This database is used for reporting side effects occurring after treatments have entered the market.
The study included 3,514 pregnancies reported between April 1, 2019, and March 31, 2023, from adolescent girls and women, ages 15 to 56. Nearly two-thirds (63.3%) were prescribed Copaxone to treat MS, while 12.5% of patients were given the medication to treat relapsing-remitting MS. Most (72.2%) used the higher dose of 40 mg/mL.
Rates of birth defects, growth problems similar to general population
Among 2,455 pregnancies with known outcomes, there were 2,512 fetuses, including cases of twins and triplets. Of these, 85% resulted in live births, the data showed. In a subgroup of 1,239 fetuses with detailed outcome data, 91.8% were live births.
Fetal losses included miscarriage (6.7%) or stillbirth (0.2%). The number of pregnancies that ended in live births, miscarriages, or terminations was similar between the two doses and comparable to those of the general population.
Some 1.5% of babies had major congenital malformations, similar to what is seen in the general population. This rate was slightly higher (1.9%) during the critical early stages of organ development. Minor birth defects occurred in 0.7% of the cases. Some babies were born preterm (9.8%) or with low birth weight (7.3%), but overall, growth remained within normal limits.
Further, according to the researchers, among the infants whose mothers used Copaxone, “the rates of hospitalization … and neurodevelopmental delays … during the first year were low.”
[The results of this four-year study] did not indicate any increased risk of [adverse events] on the mother or fetus due to in utero exposure [the medication’s use during pregnancy, with] no adverse infant outcomes or growth abnormalities … observed during breastfeeding.
One year after delivery, 384 women filled out follow-up questionnaires. Of these, 146 mothers breastfed while continuing treatment with Copaxone.
Per the researchers, the data “[suggest] that many mothers with MS actively choose to continue breastfeeding while re/starting [Copaxone] postpartum,” which they noted was “potentially influenced by perceived safety as indicated by product labeling.”
Among the breastfed infants, 11.2% of infants were hospitalized, but growth and development remained normal for most babies. The team noted that “the observed [hospitalization] rate was not higher than expected, suggesting no increased risk.”
Overall, according to the team, the results of this four-year study “did not indicate any increased risk of [adverse events] on the mother or fetus due to in utero exposure,” or the medication’s use during pregnancy, with “no adverse infant outcomes or growth abnormalities … observed during breastfeeding,” the researchers wrote.
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