Sarecycline (Seysara®)

Pregnancy

Limited available human data are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

However, sarecycline, like other tetracycline-class antibiotics, may cause fetal harm, permanent discoloration of teeth, and inhibition of bone growth when administered during pregnancy.

Tetracyclines are known to cross the placental barrier; therefore, sarecycline may be transmitted from the mother to the developing fetus.

In animal reproduction studies, sarecycline induced skeletal malformations in fetuses when orally administered to pregnant rats during the early stages of pregnancy at a dose 1.4 times the maximum recommended human dose.

Therefore, when sarecycline is used during pregnancy the potential risk to the fetus outweighs the potential benefit to the mother. Therefore, pregnant patients should discontinue sarecycline as soon as pregnancy is recognized.

Breastfeeding

All tetracyclines, including sarecycline, are excreted in human milk. Because of the potential for serious adverse reactions on bone and tooth development in nursing infants, it is not recommended that breastfeeding woman continues with sarecycline therapy.

Infertility

The use of sarecycline should be avoided in males who are attempting to conceive a child. A fertility study in rats showed that sarecycline adversely affects spermatogenesis when orally administered to male rats at a dose 8 times higher than the maximum recommended human dose.