‘Ozempic babies’: Reports of surprise pregnancies raise new questions about weight-loss drugs

(CNN) — Catera 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 upon arrival, Bentley revealed the news. They both burst into tears.

The couple, who live in Steele, Alabama, had been trying to have a child for more than two years, but Bentley’s doctor had told her she might be unable to conceive due to her history of polycystic ovarian syndrome, known as PCOS.

The news had left her aimless. “That’s all I wanted to be, was a mother and a wife,” Bentley, 25, said. “I was depressed, seriously depressed the whole time.”

Five months earlier, in October 2022, Bentley started taking Mounjaro to lose weight. In the first few months, she said, she lost about 40 pounds. Her menstrual cycles, which were irregular due to PCOS, became normal. And she felt even happier.

“It just made me feel like a whole new person,” she said. “I was in a better mood every day.”

Bentley had hoped that losing weight might help her get pregnant, and she had heard that others had successfully lost weight while taking the vaccine. But when she became pregnant – sooner than expected – she worried about the effects it might have on her baby.

“Ozempic Babies”

Bentley is far from alone. Many women have shared stories of “Ozempic babies” on social media. But the joy of discovering a pregnancy can be accompanied by anxiety about the unknowns, because these medications have not been studied in pregnant people.

“We don’t know the effect of early exposure … on the fetus,” said Dr. Jody Dushay, a physician specializing in endocrinology and metabolism at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School.

Dushay said she recommends that women stop taking these medications two months before trying to get pregnant, as directed in their prescribing information.

Ozempic and Mounjaro are part of a class of drugs called GLP-1 receptor agonists, which work by mimicking gut hormones involved in regulating insulin and appetite. They are both approved to treat type 2 diabetes and each offer sister drugs approved for weight loss. Ozempic uses the active ingredient semaglutide and Wegovy is the approved version for weight loss. Mounjaro uses tirzepatide, which also targets a second hormone called GIP, and Zepbound is its brand name for weight loss.

These medications have been shown to help people lose 15 to 20 percent of their body weight on average in clinical trials.

And because of the way GLP-1 drugs work, experts say, there are reasons they may lead to more pregnancies and urge caution about their use early in pregnancy.

An effect on birth control

On the one hand, weight loss can generally be associated with increased fertility by restoring normal ovulation in people with PCOS or other causes of abnormal cycles, said Dr. Daniel Drucker, a professor and researcher at the Mount Sinai Hospital at the University of Toronto and research pioneer. GLP-1 research.

“If you start taking these medications and then you lose 5, 10, 15 percent of your body weight, very often you will see an improvement in ovulation,” Drucker said.

A “completely conceivable” scenario, he said, would be that a person who is obese and does not have frequent periods starts taking one of these drugs, loses weight over several months and finds that she does not ‘still doesn’t have regular periods – “only now, maybe it’s because you’re pregnant.”

On top of that, Mounjaro and Zepbound have a warning in their prescribing information that they may make birth control pills less effective.

Drucker said this could be because the drugs work in part by slowing the speed at which food moves through the stomach. This may cause you to feel fuller for longer, but may also interfere with the absorption of other medications, including birth control pills.

Mounjaro and Zepbound explicitly warn against this on their labels, but Ozempic and Wegovy only warn more broadly about the absorption of any medication taken orally.

Safety during pregnancy

Although GLP-1 drugs may increase fertility, little is known about their safety during pregnancy. The drugmakers, Novo Nordisk and Eli Lilly, excluded people from their clinical trials who were pregnant or planning to become pregnant, a common practice when testing new drugs.

But that doesn’t mean no information is 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 exposure to pregnancy,” Dushay explained. In other words, “we basically collect data on “accidents,” as we do for most drugs. »

The few studies available on babies whose mothers took GLP-1 early in pregnancy have not found any major concerns, although researchers note that additional studies are needed – and they are underway. .

Novo Nordisk has a registry in which it collects data on the safety of Wegovy during pregnancy. A company spokesperson said the results would be disclosed at the end of the study. An entry in a government clinical trials database says the study plans to recruit more than 1,100 participants and is expected to be completed by summer 2027.

An Eli Lilly spokesperson said the company also plans to open a pregnancy registry for Zepbound, which was approved late last year.

Animal studies, however, suggest some reasons to exercise caution, Drucker said.

“If animals are given high doses of these drugs, very often the babies that are born to mice and rats are small and sometimes have malformations,” he noted.

This is probably because the medications also work by reducing appetite.

“If you limit energy intake in a pregnant animal, the baby will not receive enough nutrients and will not be able to grow properly,” Drucker said.

He also pointed to an animal study suggesting that GLP-1 drugs may reduce the number of proteins responsible for transferring nutrients from mother to fetus, often found in the placenta.

Already used for PCOS

These concerns complicate research into infertility medications, but work is underway on one of the most common causes: PCOS. The disease affects up to 12% of women of childbearing 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 associated with excess weight, which is believed to contribute to the body’s excess production of insulin. This in turn leads to hormonal imbalances, particularly 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 the resumption of regular ovulation and menstruation, said Dr. Anuja Dokras, clinic director of the PCOS at the University of Pennsylvania.

Lifestyle changes are the first-line treatment for PCOS, but if these interventions fail, doctors may prescribe Ozempic or other GLP-1 agonist medications, Dokras said. The 2023 international PCOS guidelines list GLP-1 agonists among medications for “management of higher weight 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.

“It’s completely used now, without any evidence, because the (obstetrics) field knows that if you lose 5 percent of weight in these people with PCOS, you will improve fertility,” she said.

Cree noted that studies have shown that liraglutide, an older GLP-1 drug sold as Victoza for type 2 diabetes and Saxenda for weight loss, is effective in reducing body weight and testosterone levels. in women with PCOS and obesity.

Cree also just completed a clinical trial investigating the use of semaglutide, the active ingredient in Ozempic and Wegovy, for the treatment of PCOS in adolescent girls. Preliminary results, which have not been published, showed that semaglutide and a low-sugar diet led to more frequent periods, lower testosterone levels and weight loss – and the weight loss was much more pronounced. in the group taking semaglutide.

Regardless of the method used, according to the study, people who lost more weight had a greater decrease in their testosterone levels.

Cree is currently conducting a larger, longer clinical trial, funded by the National Institutes of Health, that will specifically examine fertility outcomes in young women with PCOS who take semaglutide.

And while drugmakers aren’t currently conducting PCOS trials — which Cree attributes in part to the fact that PCOS overlaps so much with obesity that it wouldn’t significantly expand the drug market — approval of this disease, she stressed. This could have a significant effect on insurance coverage, which is a challenge for many people who use them for weight loss.

“For example, Colorado mandates fertility coverage, so if it were approved as a fertility drug, then it would be covered for that indication,” she said.

Separately, Cree highlighted another issue regarding medications during pregnancy: the potential for rapid weight regain that can occur when patients suddenly stop them.

“If this happens during pregnancy, when you gain all this weight, what happens? ” she says. “What does that mean?…