DEXCHLORPHENIRAMINE

Fetal Risk Summary

Dexchlorpheniramine is the dextro-isomer of chlorpheniramine (see also Chlorpheniramine). No reports linking its use with congenital defects have been located. One study recorded 14 exposures in the 1st trimester without evidence for an association with malformations (1). Animal studies for chlorpheniramine have not shown a teratogenic effect (2).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1080 newborns had been exposed to dexchlorpheniramine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 50 (4.6%) major birth defects were observed (43 expected). Specific data were available for six defect categories, including (observed/expected) 10/11 cardiovascular defects, 2/2 oral clefts, 0/0.5 spina bifida, 3/3 polydactyly, 0/2 limb reduction defects, and 4/3 hypospadias. These data do not support an association between the drug and congenital defects.

An association between exposure during the last 2 weeks of pregnancy to antihistamines in general and retrolental fibroplasia in premature infants has been reported. See Brompheniramine for details.

Breast Feeding Summary

No data are available.

References

1. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:323.
2. Product information. Polaramine. Schering Corporation, 1990.