Ethacrynic acid Pregnancy and Breast Feeding Warnings
Ethacrynic acid is also known as: Edecrin, Edecrin Sodium, Sodium Edecrin
Overview
If you become pregnant, discuss with your doctor the benefits and risks of using Ethacrynate Sodium during pregnancy. It is unknown if Ethacrynate Sodium is excreted in breast milk. Do not breast-feed while taking Ethacrynate Sodium .
Ethacrynic acid Pregnancy Warnings
Ethacrynic acid has been assigned to pregnancy category B by the FDA. If considered for use in gestational hypertension, Briggs, et al has assigned it pregnancy Risk Factor D. Animal studies have failed to reveal evidence of teratogenicity or effects on postnatal development. There are no controlled data in human pregnancy. Ethacrynic acid should only be given during pregnancy when benefit outweighs risk.
Most experts do not recommend ethacrynic acid (or any diuretics) for the routine treatment of edema or hypertension during pregnancy because, as a potent diuretic agent, ethacrynic acid can induce maternal hypovolemia and decreased placental perfusion pressure. In addition, the use of diuretics for these conditions has not been shown to improve clinical outcome. There are case reports of iatrogenic hypokalemic alkalosis in pregnant women who were aggressively treated with ethacrynic acid and furosemide for life-threatening preeclampsia. Maternal and fetal ototoxicity has been described in a 20-year-old who received ethacrynic acid 50 mg intravenously at 28 weeks gestation for acute renal failure. Both the mother's and infant's hearing loss were profound and irreversible. Interestingly, while the mother's ototoxicity was immediate, the infant's hearing loss was not measurable or detected until three years of age. Two studies by Harrison, et al, compared the outcome of ethacrynic acid versus exchange transfusion in women with severe anemia of pregnancy. In one study, ethacrynic acid 25 to 100 mg intravenously was given to 20 grossly anemic pregnant women (gestation weeks 20 to 36) to prevent acute pulmonary edema. Harrison, et al, did not comment on the fetal outcome in 2 of these 20 women. Of 18 evaluable women, 17 had normal babies. The one fetal death was associated with a spontaneous abortion in a patient who was grossly anemic and in congestive heart failure. In the second study, ethacrynic acid 50 mg intravenously was given to 47 grossly anemic pregnant women (the average gestation was 28 weeks). In 46 patients treated with exchange transfusion 1 mother and 12 fetuses died, whereas no maternal deaths and 11 fetal deaths were recorded in the patients who were treated with ethacrynic acid. The mean birth weights were 2,725 and 2,875 grams in the transfusion and ethacrynic acid-treated groups, respectively. Since most of the patients did not know the date of their last menstrual period, no data were available on the frequency of prematurity. No congenital abnormalities were found in 66 of the liveborn babies at birth and three to six months later, but complete data on the other 15 babies were not available.
Ethacrynic acid Lactation Warnings
There are no data on the excretion of ethacrynic acid during breast-feeding. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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