Atropine ophthalmic Pregnancy and Breastfeeding Warnings
Atropine ophthalmic Pregnancy Warnings
Atropine ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Atropine may be systemically absorbed after ocular administration. Atropine is only recommended for use during pregnancy when benefit outweighs risk.
Some experts recommend that the use of atropine during pregnancy be limited to its use as a preoperative, preanesthetic agent to reduce salivation and bronchial secretions. One case, in which atropine was successfully used to treat organophosphate poisoning in a woman at gestation week 35 has been reported. Atropine rapidly crosses the human placenta. In one study of 44 healthy pregnant women, a maximum umbilical to maternal vein ratio of 1.27 was observed 6 minutes after administration of 0.01 mg/kg intravenously. The corresponding umbilical and maternal vein atropine levels were 22 and 17 nmol/L, respectively. The concentrations after intramuscular injection were lower. In another study of 25 pregnant women, labeled atropine was given intravenously prior to delivery to quantify placental transfer and fetal distribution of the drug. The concentrations in the umbilical vein 1 and 5 minutes after injection were 12% and 93%, respectively, of the corresponding maternal value. Concentrations in the umbilical artery were approximately 50% of those in the umbilical vein during the same period. Studies have shown that administration of atropine to a pregnant woman during the last trimester can mask the effects of vagal stimulation on the fetal heart, producing tachycardia within 5 to 30 minutes after injection. Limited data have shown that atropine can suppress fetal breathing, although fetal hypoxia has not been observed. There has also been concern that atropine could reduce lower esophageal sphincter pressure enough to predispose the newborn to aspiration. Uterine contractility does not appear to be significantly affected by atropine. This is thought to be due to a decrease in the sensitivity of muscarinic receptors on myometrial tissue during pregnancy. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of which 401 pairs were exposed to atropine during lunar months 1 through 4. Of the 401 pairs, 25 malformed children were observed. The calculated crude relative risk for malformation associated with atropine was 0.96. These data do not support an association between the use of atropine and congenital defects. Of the 50,282 mother-child pairs, 2,323 pairs had been exposed to parasympatholytic drugs, in general. Of these 2,323 pairs, 168 malformed children were observed, yielding a crude relative risk of 1.13. These data support an possible association between the use of some parasympatholytic agents and congenital defects. The Michigan Medicaid surveillance study showed an association between the use of atropine and congenital defects (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This report is a retrospective study of 229,101 pregnant women, of whom 381 received atropine during the first trimester between 1985 to 1992. Eighteen total defects and 4 cardiovascular defects were observed (16 and 4 were expected, respectively). The incidences of total and cardiovascular defects were not statistically greater than expected. A statistically significant incidence of limb reduction defects was observed (2 observed; 0.4 expected). Cleft palate was not observed. Of the 229,101 deliveries, 3,996 had exposure to atropine at any time during pregnancy. There were no statistically significant differences between the observed and expected incidences of brain or eye abnormalities among these 3,996. These data support an association between the use of atropine and some congenital defects, although other factors, such as underlying disease(s) of the mother and concomitant medications were not controlled.
Atropine ophthalmic Breastfeeding Warnings
There are no data on the excretion of atropine into human milk. Atropine may be systemically absorbed after ocular administration. Some experts recommend cautious use of atropine during breast-feeding because of neonates' sensitivity to anticholinergic agents (probably because of immaturity of motor end-plates). The gastrointestinal bioavailability of atropine in neonates has not been reported. The American Academy of Pediatrics considers atropine to be compatible with breast-feeding.
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