Clinical Neurology News/Neurology Reviews, By Lucas
Franki
Franki
April 2, 2020
The Food and Drug Administration has updated the labels for
peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex) to include
more information about usage of these medications during pregnancy and
breastfeeding in women with multiple sclerosis (MS).
peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex) to include
more information about usage of these medications during pregnancy and
breastfeeding in women with multiple sclerosis (MS).
The FDA based the decision on data from more than 1,000
real-world pregnancies, including pregnancies from a large epidemiologic study
and published studies over several decades, which found no connection between
use of interferon-beta products during early pregnancy and an increased risk of
major birth defects, according to the FDA.
real-world pregnancies, including pregnancies from a large epidemiologic study
and published studies over several decades, which found no connection between
use of interferon-beta products during early pregnancy and an increased risk of
major birth defects, according to the FDA.
As a result, the labels for both medications will no longer
have the pregnancy category C designation; however, patients should continue to
notify their health care provider if they are pregnant or plan to become
pregnant.
have the pregnancy category C designation; however, patients should continue to
notify their health care provider if they are pregnant or plan to become
pregnant.
The FDA decision to remove the warning follows a similar
decision by the European Medicines Agency last year.
decision by the European Medicines Agency last year.
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“Many women with MS are diagnosed during their childbearing
years. With this important update for Plegridy and Avonex, healthcare providers
have more data to inform appropriate treatment paths for patients who may be
pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive
director and head of global MS at Worldwide Medical, Biogen, in a press
release.
years. With this important update for Plegridy and Avonex, healthcare providers
have more data to inform appropriate treatment paths for patients who may be
pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive
director and head of global MS at Worldwide Medical, Biogen, in a press
release.
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