Isoetharine Risk Summary
Risk Factor: CClass: Autonomics / Sympathomimetics (adrenergics)
Fetal Risk Summary
No reports linking the use of isoetharine with congenital defects have been located. Isoetharine-like drugs are teratogenic in some animal species, but human teratogenicity has not been suspected (1,2).
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 3,082 of which had 1st trimester exposure to sympathomimetic drugs (3, pp. 345356). For use anytime during pregnancy, 9,719 exposures were recorded (3, p. 439). An association in the 1st trimester was found between the sympathomimetic class of drugs as a whole and minor malformations (not life-threatening or major cosmetic defects), inguinal hernia, and clubfoot (3, pp. 345356). Sympathomimetics are often administered in combination with other drugs to alleviate the symptoms of upper respiratory infections. Thus, the fetal effects of sympathomimetics, other drugs, and viruses cannot be totally separated. However, indiscriminate use of this class of drugs, especially in the 1st trimester, is not without risk.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 22 newborns had been exposed to isoetharine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). No major birth defects were observed (one expected).
Breast Feeding Summary
No data are available.
References
- Nishimura H, Tanimura T. Clinical Aspects of The Teratogenicity of Drugs. New York, NY:American Elsevier, 1976:231.
- Shepard TH. Catalog of Teratogenic Agents. 3rd ed. Baltimore, MD:Johns Hopkins University Press, 1980:1345.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977.
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