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2.6.6.6 Reproductive and developmental toxicology Tetracylines, as a class, are known to cross the placenta and penetrate into fetal tissue. Toxic effects on the developing fetus include retardation of skeletal development. Embryotoxicity has also been noted in animals treated early in pregnancy. Teratogenicity was not reported in developmental toxicity studies of doxycycline in rats, rabbits, and monkeys. The sponsor describes a case-controlled study in humans which demonstrated a statistically significant association with total malformations and use of doxycycline in pregnancy. A small prospective study of pregnant women treated in the first trimester revealed no apparent effects on the offspring. |
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