Edarbyclor and Pregnancy

Because Edarbyclor (azilsartan/chlorthalidone) may harm a fetus, most women are not given this drug during pregnancy. Edarbyclor contains two blood pressure medications, which have been shown to cause problems like dehydration, skull deformities, and even death in a developing fetus. If you are taking this drug and become pregnant, notify your healthcare provider right away.

Can Pregnant Women Take Edarbyclor?

Edarbyclor™ (azilsartan/chlorthalidone) is a prescription medication used to lower blood pressure in people with hypertension (high blood pressure). As with all medications similar to Edarbyclor, it is not recommended for use during pregnancy, as it can harm an unborn child.

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Edarbyclor is classified as a pregnancy Category D medication.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.

What Is the Risk?

When used in the second and third trimesters, angiotensin II receptor blockers (ARBs) like Edarbyclor can cause potentially serious problems, including death, in a developing baby. Some of the problems reported in fetuses and newborns whose mothers used ARBs or angiotensin-converting enzyme inhibitors (ACE inhibitors, a similar class of medications) during the second and third trimesters of pregnancy include:
  • Low blood pressure (hypotension)
  • Skull deformities
  • Kidney problems, including kidney failure
  • Death.
In addition, low levels of amniotic fluid have been reported in pregnant women who took such medications. Low amniotic fluid levels can cause further problems to the unborn baby, such as incomplete lung development and deformities of the head and face.
At one point, it was believed that exposure to such drugs during the first trimester was not as much of a problem, and the drugs were given two pregnancy categories -- one for the first trimester and another for the last two trimesters. However, it is currently thought that these drugs are likely unsafe during any trimester.
Chlorthalidone, the other medication in Edarbyclor, is also usually avoided during pregnancy (as with other diuretics), as the dehydration that diuretics can cause can be dangerous during pregnancy.
There may be instances when Edarbyclor is the only available option for high blood pressure during pregnancy; however, this type of situation would be an extremely rare occurrence. In the event that Edarbyclor is necessary for the mother during pregnancy, amniotic fluid levels should be closely monitored. If levels become low, Edarbyclor should be stopped, unless it is absolutely necessary for the mother's life.
Pregnancy and Pain

Edarbyclor Medication Information

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