Sarecycline Pregnancy and Breastfeeding Warnings

Brand names: Seysara

Medically reviewed by Drugs.com. Last updated on May 4, 2023.

Sarecycline Pregnancy Warnings

This drug should not be used during pregnancy as the risk to the fetus outweighs the benefit to the mother; use should be avoided in males attempting to conceive a child.

US FDA pregnancy category: Not assigned.

Risk summary: This drug (like tetracycline-class agents) may cause fetal harm, permanent tooth discoloration, and reversible bone growth inhibition when used during pregnancy; insufficient data available to inform a drug-related risk for birth defects or miscarriage.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus and therapy should be stopped at once.

Animal studies have revealed evidence of embryofetal toxicity. In rats, decreased maternal body weight, fetal body weight, and litter size and increased number of resorptions and postimplantation loss observed at oral doses of 500 mg/kg/day (7 times the maximum recommended human dose [MRHD] based on AUC comparison) and skeletal malformations (bent forelimb, hindlimb, scapula) observed at all dose levels (at least 50 mg/kg/day [1.4 times the MRHD based on AUC comparison); excessive litter toxicity (litter loss, stillbirth) observed at oral doses of 400 mg/kg/day, resulting in early termination of dams at parturition. In rabbits, excessive maternal toxicity (mortality/moribundity/abortion) observed at oral doses of 150 mg/kg/day (5 times the MRHD based on AUC comparison), so this dose group was ended early; maternal moribundity also observed at 100 mg/kg/day (0.6 times the MRHD based on AUC comparison), but no significant embryofetal toxicity/malformations seen at doses up to 100 mg/kg/day. Tetracyclines are known to cross the placental barrier; this drug may transfer from the mother to the developing fetus. There are no controlled data in human pregnancy.

Spermatogenesis was adversely affected in male rats administered oral doses 8 times the MRHD (based on AUC comparison).

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Sarecycline Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown; potential for serious side effects (on bone and tooth development) from tetracycline-class drugs.
-Tetracyclines are excreted into human milk.

See references

Further information

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