Doctors are recommending that patients on Ozempic or similar diabetes and weight loss drugs use condoms instead of relying solely upon hormonal birth control because of the risk of unintended pregnancy and the possible consequences of the drugs on developing fetuses.
Some female patients on Ozempic and similar drugs, known as GLP-1s, have reported that they’ve become pregnant while on the medication despite using hormonal contraceptives or having a previous diagnosis of infertility, a phenomenon colloquially called the “Ozempic baby boom.”
Doctors are not exactly sure what about GLP-1s could cause unintended pregnancy, nor is there any concrete data on the number of women who have conceived while on the injections. However, based on animal trials, the medications may be harmful to children in the womb. Accordingly, doctors are recommending that patients use barrier methods of birth control, in addition to hormonal birth control, as an extra precaution in preventing pregnancy while taking the medication.
“I would caution anyone to use a secondary form of birth control, particularly within their first month, which would mainly be a barrier method, which is a condom,” weight loss physician Dr. Sharron Giese told the Washington Examiner.
There is some evidence that Eli Lilly’s GLP-1 tirzepatide, found in Mounjaro for Type 2 diabetes and Zepbound for weight loss, may affect the efficacy of birth control pills.
Eli Lilly explicitly tells patients to use a barrier method of birth control, like condoms, while on the injection to prevent pregnancy.
Novo Nordisk does not say that the semaglutide injections, for Ozempic for diabetes and Wegovy for obesity, directly interfere with hormonal contraception, but the company still recommends that patients rely on other forms of birth control as a precaution.
In clinical trials for both semaglutide and tirzepatide, rat, rabbit, and monkey fetuses developed significant structural abnormalities and higher miscarriage rates.
Patients for GLP-1s from both companies are strongly advised to discontinue using the injections at least two months prior to trying to conceive. If a conception occurs unexpectedly, mothers are encouraged to discontinue use immediately.
Both Eli Lilly and Novo Nordisk are investigating the pregnancy outcomes for the children of women who become pregnant while on GLP-1s and have registries for patients to self-report.
“We’re waiting to see, but so far, we’re hoping that there’s no increased miscarriage rates, no increase in birth defects,” Dr. Andrea Shields, an associate professor of obstetrics and gynecology at the University of Connecticut, told the Washington Examiner.
But even is known about how being exposed to these medications in the womb would affect the metabolism of the child long-term.
Most of the information on the so-called baby boom is anecdotal, from women who have become pregnant unexpectedly and from the physicians who treat them.
Although there is no concrete data, there are more than 1,000 members of the “I Got Pregnant on Ozempic” Facebook group, and physicians are beginning to research the phenomenon.
Dr. Christina Boots, a reproductive endocrinologist at Northwestern Medicine, told the Washington Examiner that a small number of her patients who have been on a GLP-1 drug have become pregnant despite having a prior diagnosis of unexplained infertility or polycystic ovary syndrome, or PCOS.
And that’s because they did not believe they needed to use any form of contraceptive.
“I think that’s where a lot of these Ozempic babies are coming from: women who didn’t think they could get pregnant or who don’t normally cycle all of a sudden do, and they become really fertile,” said Boots.
Neither Novo Nordisk nor Eli Lilly responded to questions about what could cause women who were either previously infertile or were on hormonal contraception to become pregnant while taking a GLP-1.
Researchers say that GLP-1s most likely do not have a direct effect on fertility, but rather affect fertility through the patients’ biochemical response to weight loss.
“You’re going to basically restore your normal hormone balance if you lose weight, and that will help with ovulation,” said Shields.
Boots said that, although there is a strong correlation between a higher body mass index, or BMI, and infertility, losing weight really only helps women with irregular menstrual cycles.
“So far, data has shown that acute weight loss does not reverse that fertility, except in this smaller cohort of women that have ovulation dysfunction, meaning that they’re not ovulating regularly, and that’s part of the reason they’re not getting pregnant,” said Boots.
Giese said, though, the psychology of losing weight may also play a role.
“I think that more people are getting pregnant on or shortly after either of the GLP-1 medications, and that is because they’re feeling better about themselves, they’re getting more social, being more comfortable in their bodies, and they’re probably having more sexual intercourse,” Giese told the Washington Examiner.
Giese also said that decreasing inflammation in the body is “equally important.”
Boots said, however, that BMI has little to do with most of the common fertility issues that her patients experience.
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“For most people, we really don’t have a lot of control over our weight, and it’s very genetically predisposed,” said Boots. “And for most people, their infertility probably isn’t very related to their weight.”
As of 2019 data from the Centers for Disease Control and Prevention, more than 15% of women between 25 and 49 have impaired fertility.