The term periconception is defined as the 12-15 weeks before conception and the 10-12 weeks after (weeks depending on the source).
Pre-Pregnancy
A woman’s nutrition and her blood glucose levels, which can be watched through her Hemoglobin A1c, can be crucial to her even getting pregnant. If Insulin Resistance or PCOS are present, the more normal the HbA1c, the more likely she will ovulate and have the possibility of getting pregnant.
With pre-pregnancy, when it comes to risks to the baby, if the HbA1c is under 7.0… better yet, 6.5… the risk of anomalies become almost the same as women without diabetes.
This is why GLP-1s might become the new Metformin for women with infertility.
However, we know so little about what the Glucagon-like peptide 1s (GLP-1) and glucose-dependent insulinotropic polypeptides (GIP) do to the embryo.
Unknown Quantities
I wrote about the lack of information or studies about women getting pregnant on GLP-1s and the effects on the developing fetus. Will the mother and growing fetus get enough nutrition? If she is removed from the GLP-1, will she gain much of her weight back? What will happen to her HbA1c? Might she get early preeclampsia? Prenatal hypertension? There are so many variables we just don’t know about.
Because I don’t want to get into an abortion debate, here is a site that discusses the embryo’s development during the first three months of pregnancy. I share this because it is relevant to the woman’s probability of not being aware she is pregnant but still on her second-line antidiabetics such as GLP-1s. If she is on Mounjaro or Zepbound, we add the glucose-dependent insulinotropic polypeptide, yet another receptor agonist to consider.
Gathering Information Begins
Here is a new review from Oct. 10, 2023 that I found: Effects of GLP-1 agonists and SGLT2 inhibitors during pregnancy and lactation on offspring outcomes: a systematic review of the evidence
This overview of studies looked at “PubMed, clinicaltrials.gov, FDA and EMA product information on GLP-1 agonists and SGLT2 inhibitors in pregnancy and lactation from inception up to 19 April 2022…” and found enough evidence to encourage stopping the GLP-1s and SGLT2 inhibitors when a woman got pregnant and to discourage taking them when nursing.
Then comes this report from Dec. 11, 2023, Safety of GLP-1 Receptor Agonists and Other Second-Line Antidiabetics in Early Pregnancy, that examined 50,000 women on second-line antidiabetics that says “Use of GLP-1 receptor agonists and other noninsulin second-line ADMs has increased in pregnancy and in this first large study on their teratogenic risk in humans, results provide initial reassurance of their safety.”
Who do we believe?
What Does the FDA Have to Say?
(emphasis mine)
Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption.
I might as well have highlighted the whole thing. Please see the complete pregnancy and nursing FDA warnings in the link above.
Without quoting, the warning label makes the If The Benefits Outweigh the Risks statement regarding a woman who has diabetes and whether she should take Mounjaro (or other GLP-1s) during pregnancy and nursing. This not only baffles me, but stuns me. Is there not enough information at this moment to weigh the risk and benefits? Aren’t there possibly other primary, secondary, or even tertiary antidiabetics that we might use because we know the outcomes better than guessing with GLP-1s?
What I Expect in Our Near Future Regarding Periconception Advice
I’m sure obstetric and neonatal researchers are watching for anything they can find, grabbing new information as it appears. What I find interesting, and a tad scary, is we really won’t know negative consequences for many years.
What do we do in the meantime?
Women have been asked to notify the the pharmaceutical company and/or the FDA if they become pregnant or are nursing on any of the GLP-1s such as Ozempic, Wegovy, Mounjaro, Zepbound, Trulicity, etc.
To report SUSPECTED ADVERSE REACTIONS for Mounjaro, Zepbound, or Trulicity, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). For Ozempic and Wegovy, contact Novo Nordisk Inc., (1-888-693-6742) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
I’m watching right along with the researchers.
