Sotagliflozin Pregnancy Warnings
Use is not recommended during the second and third trimesters of pregnancy.
US FDA pregnancy category: Not assigned
Risk summary: There is insufficient data in pregnant women to determine a drug-associated risk for major birth defects or miscarriage.
Comments:
-Animal studies suggest adverse renal effects with administration during the period of renal development corresponding to the late second and third trimesters of human pregnancy.
-Untreated heart failure in pregnancy is associated with adverse risks to the mother and fetus including preterm birth, clinical worsening of heart disease, and maternal death.
Animal studies corresponding to the first trimester period of organogenesis in humans did not demonstrate teratogenicity at doses up to 40 times the maximum recommended human dose (MRHD). However, doses 161 times the MRHD resulted in maternal and fetal toxicity. Prenatal and postnatal development studies observed an increased incidence of discolored and dilated kidneys and ureters at doses 4 times the MRHD. Drug exposure during periods of animal development corresponding to the late second and third trimesters of human development showed increased kidney weights and renal pelvic and tubular dilation at doses expected during human exposure. Renal pelvic dilatations were fully or partially reversed within a 1-month recovery period. No effects on reproductive potential or fertility were noted. There are no controlled data in human pregnancy.
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.
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Sotagliflozin Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There is no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-When a drug is present in animal milk, it is likely to be present in human milk.
-Lactational exposure may increase the risk of adverse reactions to the developing human kidney as it matures during the first two years of life.
See references
