Culture

Gracie McGraw says she takes Mounjaro for PCOS, spotlighting off-label GLP-1 use

McGraw's disclosure put PCOS into the public conversation about GLP-1 drugs, which doctors prescribe off-label for a condition their labels do not cover.

By the Semaglutides news desk··Mounjaro
Gracie McGraw says she takes Mounjaro for PCOS, spotlighting off-label GLP-1 use
Image: abcnews.com

Gracie McGraw, the 26-year-old daughter of singers Tim McGraw and Faith Hill, said on Instagram that she is taking a "low dose" of Mounjaro for polycystic ovary syndrome, or PCOS, after using Ozempic in the past [1][2]. She disclosed it in a reply to a commenter on a May 26 post: "I did use ozempic last year, yes. I am now on a low dose of mounjaro for my PCOS as well as working out. No need to accuse when I have been open about it" [2]. ABC News reported the disclosure on June 6, 2023, and Business Insider on June 7, 2023 [1][2].

McGraw first shared her PCOS diagnosis in a March 1, 2022 Instagram post, where she said a doctor had also prescribed her Ozempic and a second weight-loss medication [2]. In that post she wrote that she met four of the five characteristics used to diagnose PCOS [2]. Neither Mounjaro nor Ozempic is approved by the FDA to treat PCOS; both are approved for type 2 diabetes, and doctors may prescribe them off-label [1][2]. Mounjaro, whose active ingredient is tirzepatide, was approved in May 2022 for type 2 diabetes and was still awaiting FDA review for weight loss at the time of the reports [1][2].

PCOS affects about 1 in 10 women of childbearing age, according to the Office on Women's Health [1]. Business Insider, citing the Endocrine Society, put the figure at 5 million to 6 million women in the US [2]. The exact cause is unknown [1][2]. Many people with PCOS have insulin resistance, which raises the risk of type 2 diabetes [1][2]. Typical treatments include hormonal birth control, anti-androgen medicines and weight loss, according to the Office on Women's Health [1].

Dr. Rekha Kumar, an endocrinologist at Weill Cornell Medicine and NewYork-Presbyterian, told ABC News that drugs in this class can help with one symptom of PCOS — weight gain and the "hormonal drive to eat carbohydrate because of the insulin resistance" — rather than the condition itself. "It's not necessarily that we're using the meds to treat PCOS, but the meds can be helpful for one of the symptoms of PCOS," she said [1]. Kumar said she has prescribed this class of medicines to patients with PCOS for more than a decade [1]. Professor Adam Balen, a gynecologist and spokesperson for the Royal College of Obstetricians and Gynaecologists in the UK, previously told Business Insider that semaglutide, the ingredient in Ozempic and Wegovy, may also help manage PCOS symptoms by improving insulin sensitivity [2].

ABC News also interviewed two other women with PCOS. Branneisha Cooper, 26, of Texas, said she started Mounjaro in November and has since had monthly menstrual cycles, reduced inflammation and more than 40 pounds of weight loss [1]. Tiffany Groves, 38, also of Texas, said she was prescribed Mounjaro off-label last October after learning about it on TikTok, and that she has had regular cycles for the first time and lost about 43 pounds [1].

Why it matters for patients

For people with PCOS, the practical questions raised by McGraw's disclosure are coverage, cost and what the drugs are actually doing. Ozempic and Wegovy are both considered off-label for PCOS [1]. Kumar said she has found it harder to get prescriptions approved by insurance as the drugs' popularity has grown, pointing to "so much inappropriate prescribing" and heavy scrutiny on each prescription; without coverage, the medications can cost more than $1,000 a month [1].

Whether these drugs change PCOS itself, as opposed to weight and related measures such as insulin and menstrual regularity, has not been established in the reporting. The women quoted described symptom changes, not cures; Cooper said Mounjaro is "treating my PCOS — it's not curing it" [1].

Pregnancy is another issue doctors flagged. The FDA says the drugs should not be taken during pregnancy or while trying to conceive, citing "insufficient data," and recommends stopping treatment at least two months before planning a pregnancy. Its labeling states that "weight loss offers no benefit to a pregnant patient and may cause fetal harm" [1]. Kumar noted that treating insulin resistance can make people more fertile, so patients who thought they could not conceive may be able to [1]. Cooper and Groves both said they have plans with their doctors to stop Mounjaro if they try to become pregnant [1]. The drugs cannot be given to patients with certain conditions, including medullary thyroid cancer, pancreatitis or gallstones, and side effects can include severe nausea and constipation [1].

What happens next

Mounjaro's application for weight-loss approval was pending at the time of the reports; no decision date was disclosed [2]. It has not been reported whether any company has submitted an application to add PCOS to a label, and no large randomized trial results in PCOS were described in either report.

Images from the sources

Gracie McGraw says she takes Mounjaro for PCOS, spotlighting off-label GLP-1 use
abcnews.com
Gracie McGraw says she takes Mounjaro for PCOS, spotlighting off-label GLP-1 use
businessinsider.com
Gracie McGraw
businessinsider.com

Sources

  1. https://abcnews.com/GMA/Wellness/women-struggle-pcos-find-ozempic-mounjaro/story?id=99729389
  2. https://www.businessinsider.com/faith-hill-daughter-gracie-mcgraw-takes-ozempic-mounjaro-for-pcos-2023-6

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