Endocrine/Metabolic (Antidiabetic, Amylin Analogue)
PREGNANCY RECOMMENDATION:No Human Data—Animal Data Suggest Potential Risk
BREASTFEEDING RECOMMENDATION:Probably Compatible
No reports describing the use of pramlintide in human pregnancy have been located. With ex vivo placental perfusion studies, a minimal amount of the drug was found to cross the term placenta. However, the absence of human pregnancy experience prevents a complete assessment of embryofetal risk. Embryofetal toxicity with malformations was observed in one animal species at doses of about 10 times the RHD. In a second species, no embryofetal toxicity was seen at doses of less than 10 times the RHD, despite maternal toxicity. Using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure. This drug carries a boxed warning for an increased risk of severe hypoglycemia. Uncontrolled diabetes is associated with an increased risk for preeclampsia, spontaneous abortion, preterm delivery, IUFD, delivery complications, major malformations, and macrosomia-related morbidity. It is also a risk for maternal diabetic ketoacidosis. To lower this risk, ACOG recommends that insulin be used for types 1 and 2 diabetes occurring during pregnancy and, if diet therapy alone is not successful, for gestational diabetes. Insulin does not cross the placenta, which eliminates the additional concern that the drug therapy could adversely affect the fetus.
No reports describing the use of pramlintide during human lactation have been located. The drug may be found in human breast milk, but the amount is likely to be minimal. Furthermore, because it is a polypeptide of 37 amino acids, if the drug were to be ingested through breastfeeding, it would probably be digested in the infant’s gastrointestinal tract and not be absorbed. Breastfeeding while using this drug should be based on the mother’s clinical need for treatment versus any potential infant risks that might occur. If used, the infant should be monitored for the most common reported adult side effects of nausea and headache (both leading to irritability), vomiting, and anorexia (monitor infant growth).