Orphenadrine Pregnancy and Breastfeeding Warnings

Brand names: Antiflex, Banflex, Flexoject, Flexon, Mio-Rel, Myolin, Norflex, Norflex Injectable, Orfro, Orphenate

Medically reviewed by Drugs.com. Last updated on Aug 9, 2023.

Orphenadrine Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-Because safety has not been established, it is best to avoid use in early pregnancy unless benefits are expected to outweigh potential risks.

Animal reproduction studies have not been done. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Orphenadrine Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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