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Diltiazem Pregnancy and Breastfeeding Warnings

Diltiazem is also known as: Cardizem, Cardizem CD, Cardizem LA, Cardizem Monovial, Cardizem SR, Cartia XT, Dilacor XR, Dilt-XR, Diltia XT, Diltiazem Hydrochloride CD, Diltiazem Hydrochloride SR, Diltiazem Hydrochloride XR, Diltiazem Hydrochloride XT, Diltzac, Matzim LA, Taztia XT, Tiazac

Diltiazem Pregnancy Warnings

Diltiazem has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality, fetolethality, and teratogenicity. There are no controlled data in human pregnancy. Diltiazem should only be given during pregnancy when benefit outweighs risk.

A retrospective review of 78 women with first-trimester exposure to calcium channel blockers (CCBs) (13% or 10 were taking diltiazem) revealed no increase in major malformations compared with a control group matched for maternal age and smoking. This review suggests that CCBs do not represent a major teratogenic risk. A 34-year-old woman who was taking diltiazem 60 mg and isosorbide dinitrate 20 mg four times a day for angina pectoris delivered healthy, normal twins at 37 weeks' gestation. No adverse effects in the infants were observed.

Diltiazem Breastfeeding Warnings

A 34-year-old woman who was taking diltiazem 60 mg and isosorbide dinitrate 20 mg four times a day for angina pectoris safely nursed her twins during their first six months of life. No adverse effects in the infants were observed. A 40-year-old woman who was taking diltiazem 60 mg four times a day chose not to nurse. Her milk to serum diltiazem level ratio was nearly 1:1, indicating free diffusion of diltiazem into human milk.

Diltiazem is excreted into human milk. One report suggests that concentrations in breast milk may approximate serum levels. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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