may be consumed periconceptionally before a woman knows she is
pregnant. In this study, the authors evaluate the association of a
prescription diet drug (Letigen) containing ephedrine (20 mg) and
caffeine (200 mg) with spontaneous abortion (SAB) in the Danish National
Women were recruited during their
first prenatal visit from 1996-2002. Pre-conception and early pregnancy
medication use was reported on the enrollment form, and pregnancy
outcome was determined by linking the mother's Civil Registration Number
to the Medical Birth Registry and the National Hospital Discharge
Register. Of 97,903 eligible pregnancies, 4,443 ended in SAB between 5
and 20 completed gestational weeks, inclusive. Letigen use was reported
for 565 pregnancies. Cox regression models accounting for left
truncation were fit to estimate the effect of pre-conception and early
pregnancy Letigen use on SAB.
estimated maternal age-adjusted hazard ratio for SAB was 1.1 (95%
confidence interval 0.8-1.6) for any periconceptional Letigen use
compared to no periconceptional use.
Letigen has high levels of caffeine (the recommended 3 pills/day are
approximately equivalent to caffeine from 6 cups of coffee),
periconceptional use does not appear to be associated with an
appreciably increased hazard of clinically recognized SAB.