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Pregnancy Summary

The very limited human pregnancy data do not suggest a major risk of structural anomalies.

Breastfeeding Summary

No reports describing the use of cyclamate during human lactation have been located.

Class

Cyclamate

Drug Class: Artificial Sweetener

Pregnancy Recommendation:Limited Human Data—Probably Compatible

Breastfeeding Recommendation:No Human Data—Probably Compatible

Fetal Risk Summary

The drug has been suspected of having cytogenetic effects in human lymphocytes (1). One group of investigators attempted to associate these effects with an increased incidence of malformations and behavioral problems, but a causal relationship could not be established (2).

Placental Transfer: Cyclamate crosses the placenta to produce fetal blood levels of about 25% of maternal serum (3).

Reference(s)

  1. BauchingerM. Cytogenetic effect of cyclamate on human peripheral lymphocytes in vivo. Dtsch Med Wochenschr1970;95:2220-3.
  2. StoneD, MatalkaE, PulaskiB. Do artificial sweeteners ingested in pregnancy affect the offspring?Nature1971;231:53.
  3. PitkinRM, ReynoldsWA, FilerLJ. Placental transmission and fetal distribution of cyclamate in early human pregnancy. Am J Obstet Gynecol1970;108:1043-50.