Cleviprex Pregnancy Warnings
Animal studies have revealed increased incidences of intrauterine deaths, reduced fetal weight, retarded skeletal development, abortion, and embryo lethality at doses higher than the human dose.
In humans, other calcium channel blockers have suppressed uterine contractions.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk Summary: Available post marketing data of the use of this drug during pregnancy is not sufficient to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Comments:
-There are no adequate and well controlled studies in human pregnancy.
-There are risks to both mother and fetus associated with poorly controlled hypertension in pregnancy.
See references
