Ephedrine Pregnancy Warnings
Animal studies have not been reported. There are no controlled data in human pregnancy.
Cases of potential metabolic acidosis in newborns at delivery following maternal exposure to this drug have been reported. These reports describe umbilical artery pH of 7.2 or less.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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.
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.
Use is not recommended unless clearly needed.
AU TGA pregnancy category: A
US FDA pregnancy category:
-Most products: C
-Akovaz(TM): Not assigned.
Risk Summary (Akovaz [TM]): Limited published data is available on use of this drug in pregnant women and is insufficient to inform a drug-related risk.
Comments:
-May accelerate fetal heart rate and beat to beat variability; this drug should not be used if maternal blood pressure is greater than 130/80 mmHg.
See references
