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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 question. She was pregnant.
She called her husband at work and told him there was a giant spider in the house and he had to get rid of it. He hurried home, and when he arrived, Bentley broke the news. They both burst into tears.
The couple, who live in Steele, Alabama, had been trying to conceive for more than two years, but Bentley's doctor told her she couldn't get pregnant because of her history of polycystic ovary syndrome, also known as PCOS.
The news made her feel aimless. “Being a mother and a wife was all I wanted,” said Bentley, 25. “I was depressed, all that time I was suffering from severe depression.
Five months ago, in October 2022, Bentley started taking Mounjaro for weight loss. She said she lost about 40 kilograms in the first few months. Her irregular menstrual cycle due to PCOS became regular. And she felt more joy.
“It made me feel like a whole new person,” she said. “I was in a better mood every day.”
Bentley hoped that losing weight would help her get pregnant, and she had heard of others who had successfully lost weight while taking the vaccine. But when she became pregnant – sooner than she expected – she worried about the effect on her baby.
Bentley is far from alone. Many women have shared “Ozempic baby” stories on social media. But some of the joy of getting pregnant can come with unknown anxiety, because these drugs have not been studied in pregnant women.
“We don't know the effects of early exposure on the fetus,” said Dr. Jody Dushay, an assistant professor of endocrinology and metabolism at Beth Israel Deacon Medical Center and Harvard Medical School.
Dushay said she advises women to stop taking these drugs two months before trying to conceive.
Ozempic and Mounjaro are a class of drugs called GLP-1 receptor agonists, which mimic hormones in the gut and work to regulate insulin and appetite. Both are approved to treat type 2 diabetes and each has a twin drug approved for weight loss. Ozempic uses the active semaglutide, and Wegovy is the approved version for weight loss. Mounjaro uses tirzepatide, which targets a second hormone called GIP, and Zipbond is the brand name for weight loss.
On average, the drugs have been shown in clinical trials to help people lose 15% to 20% of their body weight.
And because of the way GLP-1 drugs work, experts say they may cause more pregnancies and be cautious about using them in early pregnancy.
For one, weight loss may be associated with increased fertility by restoring normal ovulation in people with PCOS or other irregular cycles, he says. Dr. Daniel Druckera professor and researcher at the University of Toronto's Mount Sinai Hospital and pioneer of research on GLP-1.
“If you start with these drugs and lose 5, 10, 15% of your body weight, very often, you will have an improvement in ovulation,” Drucker said.
One “very conceivable” scenario is when an obese, amenorrhoeic person starts one of these drugs, loses weight for several months, and still doesn't get a regular period — “just maybe because you're pregnant.”
Besides, Mounjaro and Zepbound have caveats in them. Order information Make birth control pills ineffective.
Drucker says 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 taking other medications, including birth control pills.
Mounjaro and Zepbound clearly warn about this in their labels, however Ozympic And Wegovi Only Widely warn about swallowing oral medications.
Although GLP-1 drugs may increase fertility, little is known about their safety during pregnancy. The drug's makers, Novo Nordisk and Eli Lilly, excluded people who were pregnant or planned to become pregnant from their clinical trials, as is common when testing new drugs.
This does not mean that there is no information.
“The more widely used these drugs are, the more women will become pregnant while taking them, and that's how we accumulate data on the risk of early pregnancy,” Dushay explained. In other words, “we basically collect data from 'accident' as we do for most drugs.
of A few Studies Babies whose mothers took GLP-1s early in pregnancy were not found to have major causes of anxiety, although researchers recognize that more research is needed — and is underway.
Novo Nordisk Registry Where to collect information about the safety of Wegovy during pregnancy. A spokesperson for the company said that the findings will be disclosed at the end of the study. An Introduction The study plans to enroll more than 1,100 participants and is expected to be completed by the summer of 2027, according to a government database of clinical trials.
A spokesman for Eli Lilly said the company plans to open the ZepBond pregnancy registry, which was approved late last year.
Animal studies, however, suggest some reasons for caution, Drucker said.
“If animals receive high doses of drugs, often, the babies born in mice and rats are small, and sometimes, some are deformed,” he said.
This is because the drugs also work by reducing appetite.
“If you restrict energy consumption in a pregnant animal, the baby will not get enough nutrients and will not be able to grow properly,” said Drucker.
In addition, research on animals has shown that GLP-1 drugs can reduce the number of proteins that are usually found in plants in the transport of nutrients from the mother to the fetus.
Those concerns complicate research for infertility drugs, but some work is underway on one of the most common causes of PCOS. The condition affects up to 12 percent of women of reproductive age in the United States US Centers for Disease Control and Prevention.
Although the exact cause of PCOS is unknown, it is related to being overweight, which is thought to contribute to the production of too much insulin in the body. This in turn causes hormonal imbalances – especially high levels of hormones such as testosterone which can stop you from ovulating and cause irregular periods, acne and excessive facial hair. CDC.
Although there is no cure, weight loss alone can significantly improve symptoms and lead to normal ovulation and menstruation, he said. Dr. Anuja DokrasDirector of the PCOS Clinic at the University of Pennsylvania.
Lifestyle changes are the first line of treatment for PCOS, but if those interventions aren't successful, doctors may prescribe Ozempic or other GLP-1 agonist medications, Docras said. of 2023 International PCOS Guidelines They list GLP-1 agonists among the drugs “for weight control in adults with PCOS.”
GLP-1 agonists improve insulin resistance and lead to weight loss, so it makes sense to improve PCOS symptoms. Dr. Melanie KriDirector of the Multidisciplinary PCOS Clinic at Children's Hospital Colorado.
“Now it's being used completely without evidence because the [obstetrics] The field knows that if you experience a 5% weight loss in these PCOS, you will improve your fertility.
Cree mentioned that Studies They showed that. LiraglutidePreviously sold as a GLP-1 drug like Victoza for type 2 diabetes and Saxenda for weight loss, it is effective in reducing body weight and testosterone levels in women with PCOS and obesity.
Cree also wrapped a Clinical trial Investigating the use of semaglutide in Ozympic and Wegovi for the treatment of PCOS in adolescent girls. Unpublished preliminary findings show that both semaglutide and a low-sugar diet led to frequent periods, lower testosterone levels, and weight loss—and the weight loss was most pronounced in the semaglutide group.
Regardless of the method, the study showed that those who lost more weight had a significant decrease in testosterone levels.
Cree is going now a A large and long clinical trialSponsored by the National Institutes of Health, it looks at fertility outcomes for young women with PCOS taking semaglutide.
And while the drug's makers aren't currently conducting trials in PCOS — partly because PCOS is too over-the-top to help prevent the drug from expanding the market too much — approval for the disease, outside, could have a significant impact on insurance coverage, which could benefit many people who use it for weight loss. It is challenging.
“For example, Colorado has mandated fertility coverage, so if it's approved as a fertility drug, it will cover that indication,” she said.
Separately, Cree addressed another question about the drugs during pregnancy: the potential for rapid weight regain when patients stop taking them suddenly.
“If this happens during pregnancy, when all this weight gain happens, what happens?” She said. “What does that mean? And we just don't know.
The makers of the drugs are also following the “Ozempic baby” phenomenon. Eli Lilly's head of research, Dr. Daniel Skowronsky, said the company has heard similar stories from patients.
“One question we're asking is: When we lose fat, do we improve fertility, do we reduce PCOS and other fertility barriers?” Skovronsky said.
“It's like heart failure or sleep apnea,” he says, referring to recent cases of GLP-1 drugs. It has been seen. Positive results. “Another weight loss benefit we haven't tested yet from this class of medicine.”
They also underscored how difficult it is to conduct research on drug delivery.