FOSINOPRIL

Fetal Risk Summary

Fosinopril is an angiotensin-converting enzyme inhibitor. In reproduction studies in rats at doses about 80 to 250 times the maximum recommended human dose on a mg/kg basis [MRHD], three similar orofacial malformations and one fetus with situs inversus were observed (1). No teratogenic effects were observed in rabbits at a dose up to 25 times the MRHD (1).

No reports of the use of this agent in human pregnancy have been located, but this class of drugs should be used with caution, if at all, during gestation. Use of angiotensin-converting enzyme inhibitors limited to the 1st trimester does not appear to present a significant risk to the fetus, but fetal exposure after this time has been associated with teratogenicity and severe toxicity in the fetus and newborn, including death. See Captopril or Enalapril for a summary of fetal and neonatal effects from these agents.

[*Risk Factor DM if used in 2nd or 3rd trimesters.]

Breast Feeding Summary

No published reports describing the use of fosinopril during lactation have been located. The manufacturer states that the drug can be detected in milk after a daily dose of 20 mg given for 3 days (1). Although the effects of this exposure on a nursing infant are unknown, the American Academy of Pediatrics classifies two other similar agents (see Captopril and Enalapril) as compatible with breast feeding because the amounts of drug excreted into milk are minimal (2).

References

1. Product information. Monopril. Bristol-Myers Squibb, 2000.
2. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.