Hydrochlorothiazide / moexipril Pregnancy and Breastfeeding Warnings
Hydrochlorothiazide / moexipril is also known as: Uniretic
Hydrochlorothiazide / moexipril Pregnancy Warnings
Hydrochlorothiazide-moexipril has been assigned to pregnancy category D by the FDA for use during the second and third trimesters and to category C during the first trimester. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with ACE inhibitors. Retrospective reviews have shown an increased risk of malformations associated with thiazide-type diuretics. There are no controlled data in human pregnancy. Congenital malformations have been reported with the use of ACE inhibitors during the first trimester of pregnancy, while fetal and neonatal toxicity, death, and congenital anomalies have been reported with the use of ACE inhibitors during the second and third trimesters of pregnancy. If the patient becomes pregnant, hydrochlorothiazide-moexipril should be discontinued as soon as possible. Hydrochlorothiazide-moexipril is considered contraindicated during pregnancy.
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Limited data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. In addition, the use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. Mothers whose embryos and fetuses are exposed to an ACE inhibitor during the first trimester should be informed of the risks. When pregnancy is detected or expected, hydrochlorothiazide-moexipril should be discontinued as soon as possible. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labor. Data from the Michigan Medicaid Birth Defects Study has revealed an association between the use of hydrochlorothiazide (HCTZ) and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 567 were exposed to HCTZ at some time during the first trimester, and 1,173 were exposed to the drug at any time during pregnancy. Of the 567 pregnancies, there were 24 total and 7 cardiovascular birth defects (22 and 6 were expected, respectively). There were no observations of cleft palate, spina bifida, limb reduction, or hypospadias. The one instance of polydactyly did not achieve statistical significance. These data are consistent with an association between the use of HCTZ and birth defects, although other factors, including underlying disease(s) of the mother are not accounted for. Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.
Hydrochlorothiazide / moexipril Breastfeeding Warnings
There are no data on the excretion of moexipril or moexiprilat into human milk. Hydrochlorothiazide (HCTZ) is excreted into human milk in low concentrations. Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of moexipril or moexiprilat in infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide-moexipril, taking into account the importance of the drug to the mother.
References for pregnancy information
- "Moexipril: another ace inhibitor for hypertension." Med Lett Drugs Ther 37 (1995): 75-6
- Mehta N, Modi N "Ace inhibitors in pregnancy." Lancet 2 (1989): 96
- Shotan A, Widerhorn J, Hurst A, Elkayam U "Risks of angiotensin-converting enzyme inhibition during pregnancy: experimental and clinical evidence, potential mechanisms, and recommendations for use." Am J Med 96 (1994): 451-6
- Rodriguez SU, Sanford LL, Hiller MC "Neonatal thrombocytopenia associated with ante-partum administration of thiazide drugs." N Engl J Med 270 (1964): 881-4
- "Product Information. Univasc (moexipril)." Schwarz Pharma, Mequon, WI.
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- Cunniff C, Jones KL, Phiullipson J, Benirschke K, Short S, Wujek J "Oligohydramnios sequence and renal tubular malformation associated with maternal enalapril use." Am J Obstet Gynecol 162 (1990): 187-9
- Lindheimer MD, Katz AI "Sodiuim and diuretics in pregnancy." N Engl J Med 288 (1973): 891-4
- Thorpe-Beeston JG, Armar NA, Dancy M, Cochrane GW, Ryan G, Rodeck CH "Pregnancy and ACE inhibitors." Br J Obstet Gynaecol 100 (1993): 692-3
- Cooper WO, Hernandez-Diaz S, Arbogast PG, et al "Major congenital malformations after first-trimester exposure to ACE inhibitors." N Engl J Med 354 (2006): 2443-51
- Schubiger G, Flury G, Nussberger J "Enalapril for pregnancy-induced hypertension: acute renal failure in a neonate." Ann Intern Med 108 (1988): 215-6
- Smith AM "Are Ace inhibitors safe in pregnancy?" Lancet 2 (1989): 750-1
- Kreft-Jais C, Plouin PF, Tchobroutsky C "Angiotensin-converting enzyme inhibitors during pregnancy: a survey of 22 patients given captopril and nine given enalapril." Br J Obstet Gynaecol 95 (1988): 420-2
References for breastfeeding information
- Miller ME, Cohn RD, Burghart PH "Hydrochlorothiazide disposition in a mother and her breast-fed infant." J Pediatr 101 (1982): 789-91
- Werthmann MW, Krees SV "Excretion of chlorothiazide in human breast milk." J Pediatr 81 (1972): 781-3
- "Product Information. Univasc (moexipril)." Schwarz Pharma, Mequon, WI.
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