Reports of surprise pregnancies raise new questions about weight loss drugs

New York Post

“I was depressed, severely depressed for that whole time.” Five months earlier, in October 2022, Bentley had started taking Mounjaro for weight loss.
“I was in a better mood every single day.” Bentley had hoped that losing weight might help her get pregnant, and she’d heard about others having success with weight loss while taking the shot.
They’re both approved to treat type 2 diabetes, and each have twin medicines approved for weight loss.
Ozempic uses the active ingredient semaglutide, and Wegovy is the version approved for weight loss.
Mounjaro uses tirzepatide, which also targets a second hormone called GIP, and Zepbound is its brand name for weight loss.
Safety in pregnancy Even as GLP-1 medicines may increase fertility, little is known about their safety during pregnancy.
The preliminary findings, which have not been published, showed that both semaglutide and a low-sugar diet resulted in more frequent periods, lower testosterone levels and weight loss — and the weight loss was much more pronounced in the group taking semaglutide.
“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.

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Looking at the positive pregnancy test, Catera Bentley was taken aback by what she saw. After taking two more tests, she was given a score of 100%. It was her pregnancy.

She informed her spouse over the phone that he needed to come get rid of a huge spider that was in the house when she called him from work. After making a hasty return home, Bentley broke the news to him. They started crying together.

The couple, who reside in Steele, Alabama, had been attempting to conceive for over two years, but Bentley’s physician had warned her that her history of polycystic ovarian syndrome, or PCOS, might prevent her from becoming pregnant.

She felt aimless after hearing the news. According to Bentley, 25, “all I wanted to be was a wife and a mother.”. “I was depressed the entire time, really depressed. “.

Bentley had begun using Mounjaro for weight loss five months prior, in October 2022. She claimed to have shed about 40 pounds in the first few months. She experienced regular menstrual cycles again after experiencing irregular ones due to PCOS. She even experienced happiness.

She remarked, “It just made me feel like a whole new person.”. Every day I was feeling better. “.

Although taking the shot, Bentley had heard of others who had successfully lost weight, and she had hoped that this could help her become pregnant as well. However, she was concerned about the potential effects on her unborn child when she unexpectedly became pregnant.

“Babies of the Olympics”.

Bentley is by no means isolated. Several women have posted accounts on social media of their “Ozempic babies.”. Yet, because these medications haven’t been tested on pregnant patients, some people may feel anxious about the unknowns along with the excitement they feel when they learn they are pregnant.

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

As instructed in the prescription information, Dushay stated that she advises women to cease taking these medications two months prior to attempting to conceive.

Mounjaro and Ozempic belong to a class of medications known as GLP-1 receptor agonists, which work by imitating gut hormones that control hunger and insulin levels. Both of them have twin medications that are authorized for weight loss, and they are both approved to treat type 2 diabetes. The version of Ozempic approved for weight loss is called Wegovy, and it contains the active ingredient semaglutide. Zepbound is the brand name for tirzepatide, which Mounjaro uses for weight loss and also targets a second hormone called GIP.

According to clinical trials, the medications can help patients lose, on average, 15% to 20% of their body weight.

According to experts, there are also reasons why GLP-1 drugs may increase the number of pregnancies and why using them in the early stages of pregnancy should be done with caution due to the way they function.

impacting birth control.

According to Dr. Daniel Drucker, a professor and researcher at the University of Toronto’s Mount Sinai Hospital who was a pioneer in the study of GLP-1, losing weight can, among other things, generally be linked to increased fertility by restoring normal ovulation in those with PCOS or other causes of irregular cycles.

“Ovulation will frequently improve if you start taking these medications and lose 5, 10, or 15% of your body weight,” Drucker stated.

He described one “quite plausible” scenario in which an obese person without regular periods starts taking one of these medications, loses weight over several months, and discovers that their irregular periods are still occurring — “only now it might be because you’re pregnant.”. “.

Moreover, the prescribing instructions for Zepbound and Mounjaro include a warning that they might decrease the effectiveness of birth control pills.

According to Drucker, this could be because the medications slow down how quickly food passes through the stomach in part. Although this may prolong feelings of fullness, it may also prevent other medications, such as birth control pills, from being absorbed properly.

While Ozempic and Wegovy merely issue a more general warning about the absorption of any medication taken orally, Mounjaro and Zepbound specifically mention this on their product labels.

safety throughout gestation.

Little is known about the safety of GLP-1 medications during pregnancy, despite the fact that they may increase fertility. As is customary when testing new medications, the drug manufacturers, Novo Nordisk and Eli Lilly, excluded participants from their clinical trials if they were pregnant or intended to become pregnant.

However, that does not imply that there is no information out there.

“More women will become pregnant while taking these medications, which will allow us to gather data on the risk of exposure to early pregnancy,” Dushay said. Stated differently, “essentially, we collect data from ‘accidents’ in the same way that we do for most drugs.”. “.

Although there aren’t many studies on babies whose mothers took GLP-1s early in pregnancy, researchers point out that more research is necessary and is currently being done.

Data regarding the safety of Wegovy during pregnancy is being gathered by Novo Nordisk through a registry. When the study is over, according to a company spokesperson, the results will be made public. The study aims to enroll over 1,100 participants and is anticipated to be finished by the summer of 2027, according to an entry on a government database tracking clinical trials.

A representative for Eli Lilly stated that the company intends to launch a pregnancy registry for Zepbound, which received approval at the close of the previous year.

However, Drucker noted that some evidence for caution has come from studies conducted on animals.

“When mice and rats are given high dosages of these medications, the infants are frequently small and occasionally malformed,” the expert said.

This is most likely due to the fact that the medications also function by decreasing appetite.

“A pregnant animal’s offspring won’t get enough nutrients and won’t be able to grow properly if you restrict their energy intake,” Drucker explained.

He also mentioned a study done on animals that suggested GLP-1 medications might lessen the amount of proteins—often found in the placenta—that are in charge of carrying nutrients from the mother to the fetus.

In use for PCOS already.

Though research on treatments for infertility is complicated by these worries, some work is still being done on PCOS, one of the most common causes of infertility. The US Centers for Disease Control and Prevention estimate that up to 12% of American women who are of reproductive age suffer from the illness.

Although the precise cause of PCOS is unknown, obesity is linked to the condition, possibly because it causes the body to produce too much insulin. Hormonal imbalances follow, specifically elevated levels of testosterone, which can prevent ovulation and lead to irregular periods, acne, and excessive facial hair, as reported by the CDC.

According to Dr. Anuja Dokras, director of the University of Pennsylvania PCOS clinic, losing weight alone can significantly improve symptoms and restore regular ovulation and menstruation, even though there is no known cure for PCOS.

Doctors may recommend Ozempic or other GLP-1 agonist medications if lifestyle modifications prove ineffective in treating PCOS, according to Dokras. GLP-1 agonists are included in the list of drugs for the “management of higher weight in adults with PCOS” in the 2023 international PCOS guidelines. “.

Dr. Melanie Cree, director of the multidisciplinary PCOS Clinic at Children’s Hospital Colorado, added that since GLP-1 agonists reduce insulin resistance and promote weight loss, it makes sense that they would also alleviate PCOS symptoms.

Because the [obstetrics] field is aware that improving fertility in PCOS patients with a 5-percent weight loss will help them become more fertile, she said, “it is completely being used now with no evidence.”.

Citing research, Cree pointed out that liraglutide, an earlier GLP-1 medication marketed as Saxenda for weight loss and Victoza for type 2 diabetes, is useful in lowering testosterone levels and body weight in women with PCOS and obesity.

The active component of Ozempic and Wegovy, semaglutide, has been the subject of a clinical trial that Cree recently concluded to examine its potential for treating PCOS in teenage girls. Semaglutide and a low-sugar diet both caused more frequent periods, decreased testosterone levels, and weight loss, but the semaglutide group’s weight loss was significantly more marked. These preliminary results have not yet been published.

The study discovered that those who lost more weight experienced larger drops in testosterone levels, regardless of the strategy.

Now, with funding from the National Institutes of Health, Cree is conducting a longer and more extensive clinical trial that will specifically examine the outcomes of fertility for young PCOS women taking semaglutide.

The fact that PCOS and obesity overlap so much that clinical trials for the condition wouldn’t significantly increase the drugs’ market share is another reason why the makers of the drugs aren’t currently conducting trials in PCOS. However, Cree notes that approval of the condition could have a significant impact on insurance coverage, which presents a challenge for many people who use the drugs to lose weight.

She stated, “For instance, Colorado requires reproductive coverage, so if it was approved as a fertility medication, then it would be covered for that indication.”.

Separately, Cree brought up another concern regarding the medications during pregnancy: the possibility of rapid weight gain in the event that patients abruptly stop taking them.

“What happens if you’re gaining all this weight while pregnant and that’s happening?” she questioned. We just don’t know what that means. “.

A “Catch-22”.

The manufacturers of the drugs are keeping an eye on the “Ozempic babies” trend as well. Dr. Daniel Skovronsky, chief research officer at Eli Lilly, says the company has heard similar patient narratives.

Skovronsky stated, “We’re wondering if there’s a chance that improving fat loss will increase fertility and lower PCOS and other barriers to it.”.

Referring to conditions for which GLP-1 drugs have recently shown promising results, he said, “it’s kind of like heart failure or sleep apnea.”. Just one more possible advantage of weight loss from this class of drugs that we haven’t yet investigated. “.

Additionally, he emphasized how difficult it is to conduct research on the fertility of medications whose safety in pregnancy is unknown; in particular, Cree described the need for birth control as a “Catch-22” for GLP-1 drug studies.

The risks to the unborn child have not yet been thoroughly examined, so it is currently very difficult to investigate how these medications affect fertility because doing so implies exposing women to a drug that carries a high risk of pregnancy during exposure.

When Bentley learned she was pregnant, she immediately stopped taking Mounjaro, according to the woman who became pregnant while taking the medication. However, she stated that she was still concerned about the medication’s impact on her unborn child.

She remarked, “I worried until the day I had her.”.

Ivy, her daughter, weighed seven pounds and seven ounces when she was born on schedule and in good health. After Ivy was born, Bentley resumed taking Mounjaro six weeks later.

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