Metaxalone Pregnancy and Breastfeeding Warnings

Brand names: Metaxal, Metaxall, Skelaxin

Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.

Metaxalone Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no available data on the use in pregnant women to know the drug-associated risks, including the risk of fetal harm or reproductive effects.
-This drug should not be used in women who are or could become pregnant, particularly during early stages of pregnancy unless, the potential benefits outweigh the possible risks.

Animal reproduction studies have not revealed evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy. Postmarketing experience has not revealed evidence of fetal injury, but the possibility of damage to the human fetus cannot be excluded.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Metaxalone Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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