The FDA has classified diltiazem as a pregnancy Category C medication, meaning it may not be safe to take the drug during pregnancy. During animal studies of diltiazem and pregnancy, the drug increased the risk of miscarriages and birth defects (such as skeletal problems). However, a healthcare provider may still prescribe diltiazem to a pregnant woman if the benefits to the woman outweigh the risks to her unborn child.
Is Diltiazem Safe During Pregnancy?
For people who are pregnant, diltiazem hydrochloride may not be safe. This is based on animal studies that looked at the effects of diltiazem during pregnancy.
Diltiazem and Pregnancy Category C
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.
Diltiazem was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, diltiazem caused an increased risk of miscarriages and birth defects (especially skeletal problems).
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Diltiazem and Pregnancy: Final Thoughts
If you are pregnant or thinking of becoming pregnant while taking diltiazem, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using diltiazem during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
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