DIMETHINDENE

Fetal Risk Summary

Reproductive toxicity studies using dimethindene in rats (up to 200 mg/kg/day orally or 16 mg/kg/day IV) and rabbits (up to 50 mg/kg/day orally) revealed no embryolethality or teratogenicity (personal communication, GJ Golden, Zyma Switzerland, 1995). Embryotoxicity (decreased fetal weight and slight retarded ossification) was observed in rats at the highest dose, but not in rabbits.

The Collaborative Perinatal Project monitored 113 pregnancies who were exposed to a miscellaneous group of antihistamines during the 1st trimester (1). Two patients in the group took dimethindene. No association was found between the drug exposure in the total group and congenital defects.

Breast Feeding Summary

Very small amounts of dimethindene are excreted in the milk of lactating rats (personal communication, GJ Golden, Zyma Switzerland, 1995). One source states that the drug is contraindicated during lactation, but no reasons for this statement were given (2). No studies describing the use of dimethindene during human lactation or measuring the amount of drug in human milk have been located.

References

1. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:323.
2. Onnis A, Grella P. The Biochemical Effects of Drugs in Pregnancy. Volume 1: Drugs Active on the Nervous, Cardiovascular and Haemopoietic Systems. West Sussex, England:Ellis Horwood, 1984:248.