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Nitroglycerin Pregnancy and Breastfeeding Warnings

Nitroglycerin is also known as: Deponit, Minitran, Nitrek, Nitro TD Patch-A, Nitro-Bid, Nitro-Bid IV, Nitro-Dur, Nitro-Par, Nitro-Time, NitroMist, NitroQuick, Nitrocot, Nitrodisc, Nitrogard, Nitroglyn E-R, Nitrol, Nitrol Appli-Kit, Nitrolingual Pumpspray, Nitrong, Nitrostat, Nitrostat Tablets, Rectiv, Transderm-Nitro, Tridil

Nitroglycerin Pregnancy Warnings

Data on the use of nitroglycerin during human pregnancy is limited. While it has been used safely and effectively to treat maternal hypertension and angina, it has also caused maternal hypotension, with subsequent fetal heart rate changes, including bradycardia and late decelerations, after intravenous administration for these conditions and when used to decrease the risk of hypertension associated with intubation. Some experts are very cautious of the possibility of nitroglycerin-induced hypotension, which may result in decreased uteroplacental perfusion and fetal hypoxemia. Hypotension appears to be less likely if the mother's intravascular volume is replete before nitroglycerin administration. The Collaborative Perinatal Project recorded seven first trimester exposures to nitroglycerin and amyl nitrite and eight patients on other vasodilators. Four malformed infants resulted from this group, although it is not clear whether the mothers of the affected babies had taken nitroglycerin. Data from the Michigan Medicaid Birth Defects Study failed to reveal an association between the use of nitroglycerin and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration). This was a retrospective study of 229,101 completed pregnancies between 1985 to 1992, of which 50 were exposed to nitroglycerin at some time during the first trimester and 102 were exposed to the drug at any time during pregnancy. Of these pregnancies, one birth defect was observed. This observation did not achieve statistical significance. There were no observations of cardiovascular defects, cleft palate, spina bifida, polydactyly, limb reduction, or hypospadias. These data do not support an association between nitroglycerin and birth defects, although conclusions have not been made based on the small number of pregnancies with known exposure to the drug.

Nitroglycerin has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted. There are no controlled data in human pregnancy. Nitroglycerin should only be given during pregnancy when benefit outweighs risk.

Nitroglycerin Breastfeeding Warnings

There are no data on the excretion of nitroglycerin into human milk. The manufacturer recommends caution when administering nitroglycerin to nursing women.

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