Amlodipine and telmisartan Pregnancy Warnings
This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus; contraindicated per some authorities.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: Discontinue this drug as soon as possible upon detection of pregnancy.
Comments: Adequate methods of contraception should be encouraged.
Animal studies with amlodipine have revealed increased intrauterine deaths. Animal studies with telmisartan have revealed evidence of fetotolethality. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.
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