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Katera Bentley looked at the positive pregnancy test and couldn’t believe her eyes. She took a second test, then a third. There was no doubt about it—she was pregnant.
She called her husband at work and told him there was a giant spider in the house that he needed to come get rid of. He rushed home and when he arrived Bentley broke the news.
They both burst into tears.
The couple, who live in Steele, Alabama in the US, had been trying to have a child for more than two years, but Bentley’s doctor had told her she might not be able to conceive due to her history of polycystic ovary syndrome, known as PCOS.
The news had left her speechless.
“That’s all I wanted to be … a mother and a wife,” Bentley, 25, said.
“I was depressed, severely depressed all this time.”
Five months earlier, in October 2022, Bentley began taking Mounjaro for weight loss.
In the first few months, she said she lost about 18 kg. Her menstrual cycles, which had been irregular due to PCOS, are returning to normal. And she even felt happier.
“It just made me feel like a whole new person,” she said. “Every day I was in a better mood.”
Bentley hoped the weight loss might help her get pregnant, and had heard of others who had managed to lose weight while taking the photo.
But when she became pregnant – sooner than she expected – she worried about the effects it might have on her baby.
“Azerbaijani Babies”
Bentley is far from alone. Many women are sharing stories about “Ozempic babies” on social media.
But the joy of a known pregnancy discovery experience can come with anxiety about the unknown, as these drugs have not been studied in people who are pregnant.
“We don’t know the effect of early exposure … on the fetus,” said Dr. Jody Dushay, a physician who focuses on endocrinology and metabolism at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School.
Dushay said she recommends women stop taking these drugs two months before trying to conceive, as directed in the prescribing information.
Ozempic and Mounjaro are part of a class of drugs called GLP-1 receptor agonists, which work by mimicking hormones in the gut involved in regulating insulin and appetite.
Both are approved to treat type 2 diabetes and each has a dual drug approved for weight loss.
Ozempic uses the active ingredient semaglutide, with Wegovy being the version approved for weight loss, while Mounjaro uses tirzepatide, which also targets a second hormone called GIP, and Zepbound is its weight loss brand.
In clinical trials, the drugs have been shown to help people lose an average of 15 percent to 20 percent of their body weight.
And because of the way GLP-1 drugs work, experts say there are reasons why they can lead to more pregnancies — as well as reason to be cautious about using them in early pregnancy.
Effect on birth control
For one thing, weight loss can usually be linked to increased fertility by restoring normal ovulation in people who have PCOS or other causes of abnormal cycles, said Dr. Daniel Drucker, a professor and researcher at the University’s Mount Sinai Hospital in Toronto and a pioneer in GLP-1 research.
“If you start on these drugs and then lose 5, 10, 15 percent of your body weight, you will very often have an improvement in ovulation,” Drucker said.
One scenario that is “quite possible” is someone who is obese and has irregular periods, starts taking one of these drugs, loses weight, but finds she still doesn’t have a regular period — “only now it could be because you’re pregnant,” he said.
Mounjaro and Zepbound also warn in their prescribing information that they can make birth control pills less effective.
Drucker said this may be because the drugs work in part by slowing the rate at which food moves through the stomach. This can make people feel fuller for longer, but it can also interfere with the absorption of other medications, including birth control pills.
Mounjaro and Zepbound specifically warn about this on their labels, but Ozempic and Wegovy only warn more broadly about the absorption of any drugs taken by mouth.
Safety during pregnancy
Although GLP-1 drugs may enhance fertility, little is known about their safety during pregnancy. The drug makers, Novo Nordisk and Eli Lilly, have excluded people who are pregnant or planning to become pregnant from their clinical trials, a common practice when testing new drugs.
But that doesn’t mean there isn’t information available.
“The more these drugs are used, the more women will become pregnant while taking them, and thus we will accumulate data on the risk of early pregnancy exposure,” explained Dushai.
In other words: “We mainly collect data from ‘accidents’ as we do for most drugs.”
The few available studies of infants whose mothers took GLP-1s early in pregnancy have found no major cause for concern, although the researchers note that more study is needed — and is underway.
Novo Nordisk has a registry collecting data on the safety of Wegovy during pregnancy, which a company spokesperson says will be made public at the end of the study – believed to be in 2027.
An Eli Lilly spokesman said the company also plans to open a pregnancy registry for Zepbound, which was approved late last year.
However, animal studies suggest some reason for caution, Drucker said.
“If animals are given high doses of these drugs, very often the babies … are small and sometimes have some malformations,” he noted.
This is probably because the drugs also work by reducing appetite.
“If you restrict the energy intake of a pregnant animal, then the baby will not get enough nutrients and will not be able to grow properly,” Drucker said.
He also pointed to an animal study that suggests GLP-1 drugs can reduce the number of proteins often found in the placenta that are responsible for transferring nutrients from mother to fetus.
Already used for PCOS
These concerns complicate research into fertility drugs, but some work continues on one of the most common causes: PCOS.
The condition affects up to 12 percent of women of reproductive age in the United States, according to the U.S. Centers for Disease Control and Prevention.
The exact cause of PCOS is unknown, but it is linked to being overweight, which is thought to contribute to the body producing too much insulin.
This, in turn, leads to hormonal imbalances — specifically, higher levels of hormones like testosterone, which can stop ovulation and cause irregular periods, acne and excess facial hair, according to the CDC.
Although there is no cure, weight loss alone can lead to significant improvement in symptoms and resumption of regular ovulation and menstruation, said Dr. Anuja Dokras, director of the PCOS Clinic at the University of Pennsylvania.
Lifestyle changes are the first-line treatment for PCOS, but if those interventions aren’t successful, doctors may prescribe Ozempic or other GLP-1 agonist drugs, Dockras said.
The 2023 international guidelines for PCOS list GLP-1 agonists among drugs for “higher weight management in adults with PCOS.”
GLP-1 agonists improve insulin resistance and lead to weight loss, so it makes sense that they also improve PCOS symptoms, added Dr. Melanie Cree, director of the multidisciplinary PCOS clinic at Children’s Hospital Colorado.
“Now it’s used completely without evidence because (obstetrics) knows that if you have a 5% weight loss in these individuals with PCOS, you’re going to improve fertility,” she said.
Cree is currently conducting a clinical trial funded by the National Institutes of Health that will specifically look at fertility outcomes in young women with PCOS taking semaglutide.
But Cree pointed out another issue with the drugs during pregnancy: the potential for rapid weight regain that can occur when patients stop them suddenly.
“If this happens during pregnancy, when you gain all this weight, what happens?” she asked.
“What does that mean? And we just don’t know.”
“Catch-22”
Drug manufacturers are also monitoring the Ozempic babies phenomenon. Eli Lilly’s head of research, Dr. Daniel Skowronski, says the company has heard similar stories from patients.
“One question we’re asking is: Is it possible that while we’re reducing fat, we’re improving fertility, reducing PCOS and other barriers to fertility?” Skowronski said.
“It’s kind of like heart failure or sleep apnea,” he said, referring to conditions for which GLP-1 drugs have recently shown positive results.
“Just another potential weight loss benefit from this class of drugs that we haven’t tested yet.”
He also highlighted how difficult it is to conduct fertility studies on drugs whose safety during pregnancy is unknown. Cree refers to a birth control requirement in studies of GLP-1 drugs as “Catch-22” for fertility indications.
“Right now, unfortunately, it’s really difficult to study the effects of these drugs on fertility because it involves exposing women to a drug with a high risk of them becoming pregnant while exposed to the drug, and the risks to the baby haven’t been fully analyzed yet.” Skowronski said.
Bentley, who became pregnant while taking Mounjaro, said she stopped taking the drug as soon as she found out she was pregnant. But she said she continues to worry about the drug’s effect on her baby.
“I worried until the day I had her,” she said.
Her daughter Ivy was born healthy at term weighing 3.4 kg. Bentley started taking Mounjaro again six weeks after Ivy was born.
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