Ozempic and Wegovy share the frequent unwanted side effects of nausea and urge for food loss, however there’s one lesser-known danger issue that isn’t talked about almost as usually.
The two semaglutide-containing drugs — Ozempic for sort 2 diabetes management and Wegovy for weight reduction — may additionally pose a severe danger to unborn infants.
Animal research have proven that when pregnant rabbits, rats and monkeys got semaglutide, they skilled greater charges of miscarriage, beginning defects and small fetal measurement — data that’s included in the drug labels for each drugs, that are made by Novo Nordisk in New Jersey.
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Ozempic remains to be wildly common, with greater than 4 million lively prescriptions, per the producer’s web site. While it’s marketed as a diabetes-controlling medicine, it’s additionally well-known for its frequent off-label use as a weight reduction support.
There has additionally been rising demand for its weight reduction counterpart, Wegovy — a lot that Novo Nordisk introduced earlier this month it is going to be limiting the availability of some starter doses.
Semaglutides are in a bunch of medicines referred to as glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
They work by imitating the habits of the GLP-1 hormone, which is launched in the intestine after consuming and triggers the physique to produce insulin.
Doctors issue warning throughout pregnancy
Dr. Rekha Kumar, chief medical officer at the medically supported weight care program Found and a practising endocrinologist in New York City, advises her sufferers to cease taking semaglutide-containing drugs in the months main up to pregnancy.
“Given the fact that these medicines have not been studied in pregnancy, I would recommend stopping the long-acting ones like Ozempic and Wegovy two to three months before,” she advised Fox News Digital in an interview.
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Whenever she prescribes FDA-approved medication for weight reduction, Kumar mentioned she at all times has a dialog with sufferers about whether or not they’re attempting to get pregnant or in the event that they’re on contraception.
“And if we’re prescribing any medicine that could be contraindicated, we let them know,” she mentioned.
In instances the place diabetes or weight administration is crucial to the well being of sufferers, Kumar typically switches them to a shorter-acting every day medicine, akin to phentermine for weight reduction or metformin for diabetes, which might be taken up till a month earlier than pregnancy.
There’s a marked distinction between sufferers who’re utilizing Ozempic for diabetes versus these utilizing Wegovy for weight reduction, the physician identified.
That’s as a result of weight reduction shouldn’t be suggested whereas somebody is pregnant.
“If you look at the American College of Obstetrics and Gynecology’s weight gain guidelines, nobody is recommended to lose weight during pregnancy,” Kumar advised Fox News Digital. “The amount of weight you’re recommended to gain is based on your pre-pregnancy BMI.”
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Even for girls who’re obese or have weight problems, the most strict advice could be to not achieve any weight, the physician mentioned.
It’s a special story for sufferers who’ve diabetes.
“The assumption is that they’re on a medicine that’s critical for managing a disease,” Kumar defined. “In that case, I’ll switch them to insulin during pregnancy.”
“Nobody is recommended to lose weight during pregnancy.”
Dr. Sue Decotiis, a weight reduction doctor in New York City who focuses on Ozempic, Mounjaro and different weight reduction drugs, additionally mentioned she recommends that her sufferers cease taking these medicine in the event that they turn into pregnant.
“We really don’t know what the risks are because they haven’t done any real studies, and I don’t believe that we’re going to see hideous long-term side effects — but then again, who wants to take the chance?” she mentioned in a dialog with Fox News Digital.
In one other twist, semaglutide drugs can really assist girls get to some extent the place they’re in a position to conceive after they initially didn’t suppose they’d find a way to, mentioned Decotiis.
“We know that insulin resistance is a leading cause of infertility,” she mentioned.
“A lot of people have reported that they were insulin-resistant and overweight, and that their periods were very irregular.”
“Thus, when we correct the insulin resistance with these medications, people start getting regular periods and start getting pregnant,” she went on. “So that’s one added benefit of the drug.”
Many of Kumar’s sufferers have a long-term plan to take the medication, lose a desired quantity of weight and then attempt to get pregnant.
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If a girl on a semaglutide medicine finds out she’s pregnant, Kumar mentioned she will cease taking it instantly — however in a best-case state of affairs, she recommends truly fizzling out.
“This would allow the woman to monitor the compensatory hunger that comes back after stopping and implement other interventions and lifestyle changes, such as increasing dietary protein,” she mentioned.
FDA requires investigation
Based on experiences from girls who’ve skilled miscarriage or different pregnancy points whereas taking these drugs, the FDA is now requiring Novo Nordisk to conduct an investigation.
The firm can have to hold a registry of any reported points after publicity throughout pregnancy, together with “major and minor congenital malformations, spontaneous abortions, stillbirths, elective terminations, small for gestational age, preterm birth and any other adverse pregnancy outcomes,” in accordance to the FDA’s letter.
On Reddit, one person shared that about 10 months in the past she turned pregnant whereas on Ozempic.
“This was quite a shock to me because we tried for three years to conceive naturally and had to go the gauntlet of IVF to have a baby,” she wrote.
“I delivered my son last September, quit breastfeeding in December and started Ozempic, conceived on March 22 (without knowing) and miscarried on April 26. What a shock this was to my entire family.”
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Five months in the past, one other person shared that she obtained pregnant whereas taking the medicine. The child stopped rising at 5 weeks — the lady miscarried at 8 weeks.
Not all experiences ended badly, nevertheless.
Other girls shared that they skilled wholesome pregnancies even after being on a semaglutide medicine earlier than discovering out they’d conceived.
Drugmaker echoes warning
When conducting its trials of semaglutide drugs, Novo Nordisk excluded girls who had been pregnant or supposed to turn into pregnant, the firm mentioned in a press release to Fox News Digital.
“There are therefore limited clinical trial data with semaglutide use in pregnant women,” the assertion continued.
“However, information related to pregnancy appears in Section 8.1 and 8.3 of the prescribing information for both Ozempic and Wegovy.”
“I don’t believe that we’re going to see hideous long-term side effects — but who wants to take the chance?”
That data consists of the following warning: “Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy, [Ozempic and Wegovy] should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Said the firm, “Pregnant women exposed to [Ozempic and Wegovy] and health care providers are encouraged to contact Novo Nordisk at 1-800-727-6500.”
Novo Nordisk additionally identified that whereas Wegovy and Ozempic each include semaglutide, they’re totally different merchandise with totally different indications, dosages, prescribing data, titration schedules and supply gadgets.
“The products are not interchangeable and should not be used outside of their approved indications,” the assertion mentioned.
Ozempic is FDA-approved for the remedy of sort 2 diabetes, to enhance blood sugar, together with eating regimen and train, and cut back the danger of main cardiovascular occasions akin to coronary heart assault, stroke or dying in adults with sort 2 diabetes and identified coronary heart illness, in accordance to the firm.
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Wegovy is FDA-approved for persistent weight administration in adults with weight problems (BMI > 30) or obese (BMI > 27) who even have weight-related medical issues, used with a reduced-calorie meal plan and elevated bodily exercise, Novo Nordisk mentioned.
End purpose: A more healthy pregnancy
While semaglutides carry potential dangers throughout pregnancy, Kumar emphasised that when prescribed correctly to a girl who’s struggling together with her metabolic well being, these drugs may assist allow a more healthy pregnancy.
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“If somebody is using contraception and they’re under the care of an OB-GYN and an endocrinologist and they’re at risk of gestational diabetes, taking this medicine for a period of time might actually allow them to get pregnant more easily and lower their risk of gestational diabetes,” she defined.
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“So when used appropriately in women that desire fertility, there is an appropriate way to do it.”