Ozempic®, commonly known as semaglutide, when introduced in the body clones the function of the glucagon hormone. The glucagon hormone helps in controlling the blood sugar and insulin levels and aids proper digestion. It is a single-patient-use injection pen that is pre-filled and disposable after use. The primary function of Ozempic® is to improve the blood sugar levels among patients that are suffering from type 2 diabetes mellitus and have troubles producing glucagon. This medication, however, cannot be used for treating type 1 diabetes. In most cases, this medication is offered to the patients only after other medicines have failed to control the blood sugar levels.
Medicines are made with multiple chemical compounds. This raises the risks associated with their interaction with the human body. There are certain medicines that must be avoided when the human body is going through multiple bodily changes. One such change is pregnancy. Read along to know more about using Ozempic® in pregnancy and lactation.
There is not enough data in relation to the use of Ozempic® among women as there haven’t been enough studies for the same. This raises the inability to relate an informed drug-associated risk about adverse developmental patterns for the offspring. However, there are a few studies that resulted in clinical considerations about the medication and poorly controlled pregnancy with diabetes (mentioned below in the “clinical considerations” section).
Studies on animals have shown that there might be a few risks associated with the administration of this drug during pregnancy. The potential risks were associated with the fetus as well as the mother. In any case, Ozempic® must be introduced into the body only if the potential risks outweigh the potential risks to the fetus.
Studies were conducted on animals to understand the required dosage on humans and the impact of the medicine’s usage on a pregnant woman as well as the fetus. These studies were conducted using pregnant rats, rabbits, and cynomolgus monkeys.
The rats were administered with Ozempic® during organogenesis. There were observations of structural abnormalities and alterations in growth even with the dosage being well below the maximum recommended human dose (MHRD). In the rabbits and cynomolgus monkeys, there were observations of early pregnancy losses and skeletal abnormalities.
For a planned pregnancy, it is advised to discontinue Ozempic® a minimum of two months prior to it. This is in accordance with the long washout period for Ozempic®.
Clinical considerations– There are multiple considerations associated with medicines taken during pregnancy. There are many risks associated with the clash of diabetes and pregnancy medication. An inconsistency in controlling diabetes during pregnancy can lead to maternal issues like diabetic ketoacidosis, spontaneous abortions, preterm delivery, stillbirth, and pre-eclampsia. The inconsistency can affect the fetus as well. Birth defects, stillbirth, and macrosomia related morbidity are a few associated risks.
Observations– There were multiple studies conducted using animals to understand the varied potency of Ozempic®. A combined embryofetal development study and fertility study in rats were conducted with doses of 0.01, 0.03, and 0.09 mg/kg/day (0.1-, 0.4-, and 1.1-fold the MHRD), administered in male rats 4 weeks prior to mating and 2 weeks prior to mating in the females. It was also administered in the organogenesis period all the way to the gestation day 17. Reductions in body weight gain and food consumption were observed among parental animals. As for the offspring, there was a slowness in growth and fetuses were born with visceral and skeletal abnormalities.
In a study conducted in pregnant cynomolgus monkey, they were injected with doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (1.0-, 5.2-, and 14.9-fold the MRHD). These were administered throughout organogenesis: Gestation Day 16 to 50. The doses marked body weight loss in the mother along with a reduction in food consumption pattern. There were other sporadic abnormalities at 0.075 mg/kg twice weekly.
A study of embryo-fetal development was conducted among pregnant rabbits. Subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.03-, 0.3-, and 2.3-fold the MRHD) were introduced in the animal’s body through organogenesis from Gestation Day 6 to 19. There were similar observations for all the dosage levels with a reduction in the body weight and food consumption. Incidences of minor visceral and skeletal fetal abnormalities, as well as early pregnancy losses, were observed.
There are have been limited or no observations of the presence of Ozempic® in breast milk during lactation. Subsequently, it has been noted to not have an impact on the breastfed infant nor has it affected the production of breast milk. A part of the aforementioned studies showed the presence of Ozempic® in rats. However, this was due to species-specific differences in the lactation physiology of rats. There must be a close consideration of developmental and health benefits associated with breastfeeding and the clinical need for Ozempic®.