AZOR and Pregnancy

The FDA has classified AZOR (amlodipine and olmesartan) as a pregnancy Category C medication when it is used during the first trimester and a pregnancy Category D medication when used during the second and third trimesters. In animal studies involving AZOR and pregnancy, the ingredients in AZOR caused problems in the fetus (such as fetal death, kidney damage, and facial deformity). However, a healthcare provider may still recommend AZOR if the benefits outweigh the risks.

 

An Overview of AZOR and Pregnancy

AZOR™ (amlodipine and olmesartan) may not be safe for use during pregnancy. This conclusion is based on animal studies and on problems that have been reported when pregnant women took olmesartan (one of the components of AZOR).
 

AZOR and Pregnancy Category C and D

AZOR is a pregnancy Category C drug when used in the
 first trimester and a pregnancy Category D drug when used during the second or third trimesters.
 
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in pregnant women, but may still offer benefits that outweigh the possible risks. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Amlodipine has been shown to increase the risk of miscarriages in rats, but it has not been studied in any pregnant humans. More importantly, medications like olmesartan have been shown to cause severe problems in pregnant women, especially when used in the second and third trimesters. These types of medications have caused the following problems:
 
  • Fetal death (a miscarriage or stillbirth)
  • Low blood pressure in the fetus
  • Problems with the skull of the fetus
  • Kidney damage (including kidney failure)
  • Low amniotic fluid
  • Facial deformity
  • Lung problems
  • Heart problems.
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There may be rare cases when AZOR may be necessary during pregnancy. In these cases, the level of amniotic fluid should be monitored regularly and AZOR should be stopped if the fluid becomes too low (unless AZOR is considered to be life-saving for the mother).
 
(AZOR and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;