Combigan Pregnancy Warnings
Animal studies have shown reproductive toxicity at high doses. There are no adequate and well-controlled studies in pregnant women.
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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned
Comments:
-Signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress, and hypoglycemia) have been observed in the neonate when beta-blockers have been administered until delivery.
-If this drug is administered in pregnancy until delivery, the neonate should be monitored during the first days of life.
See references
