CAPE GIRARDEAU, Mo. (KFVS) – What started as a treatment for diabetes has quickly become the latest weight loss trend.
Ozempic.
Mounjaro.
They’re used by people to treat Type 2 diabetes, but now thousands in the Heartland are using injections readily available at local clinics and physicians’ offices.
And people can’t wait to get their hands on them, even though these compounded versions of the drugs are the source of pending lawsuits and U.S. Food and Drug Administration warnings.
“It is so discouraging when you feel like you are getting bigger and bigger and there is no stopping,” said Rachel Mettlen, a patient at a Cape Girardeau clinic.
“I did not want to look in the mirror, my clothes didn’t fit anymore,” said Rebecca McClanahand, a patient at a Cape Girardeau clinic. “I just felt depressed.”
There’s the feeling of defeat – the pounds don’t come off when you step on the scale.
“Anything I needed to do to make the progress,” McClanahand said.
That includes weekly injections many patients do at home.
“A lot of patients, this is their last resort,” said Crista Merriman, nurse practitioner at Alliance Dermatology in Cape Girardeau. “They have tried everything for years and years and years, and just can’t get down to where they would like to be.”
The beginning
It all started as a way to treat diabetes, but it became so much more.
Ozempic quickly became a popular diet drug and it’s still only approved for diabetes.
But there’s another, Wegovy, which is made by the same company, Novo Nordisk.
It’s approved for weight loss.
Then another drug came into the picture.
Mounjaro is made by Eli Lilly & Company. It’s only approved for diabetes.
All three medications have the same results – patients losing weight.
Now, the drugs are popular and supply is low.
“We are aware that the demand is high for Ozempic and Wegovy,” Allison Schneider, the director of media relations and issues management for Novo Nordisk, said in a statement emailed to KFVS. “As we work to increase the supply of our treatments to meet patient demand we will distribute our existing supply across markets in a responsible manner consistent with our focus on continuity of care and access to innovative medicines.”
“While we respect every healthcare provider’s clinical expertise and their right to prescribe treatment based on their own medical judgement, we ask that healthcare professionals prescribe our medicines consistent with their FDA-approved indications.”
According to the FDA, when a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements.
Opening the floodgates
The compounded versions of the drugs have opened the doors for those who want it.
“Right now, we have in excess of 600 patients on it currently,” said Dr. Anthony J. Keele, the medical director of EBO MD in Cape Girardeau.
“We counted up recently, I have close to 200 weight loss patients total on both the semaglutide and tirzepatide,” Merriman said, “which both are subcomponents of Mounjaro and Ozempic.”
The compounded medications use the active ingredients that are in the name brand drugs, and Keele and Merriman both prescribe these shots.
“It is almost a perfect drug,” Keele said. “It suppresses the appetite in the brain. It slows gastric emptying, so what that means is, if you eat a meal, you can’t finish your plate because you get full so fast.”
Merriman said she has had patients have success on the compounded shots.
“Typically people lose six to 10 pounds the first month on the semaglutide,” she said. “And then on the tirzepatide, it’s about 10 pounds a month – is what we are seeing on average.”
Both say the results vary on the person.
“I’ve had some male patients that lost about 150 pounds over a six-month period and they were not hitting the gym six days a week or anything,” said Dr. Keele.
Taking that chance
Many doctors say the drugs aren’t for everyone. It’s not one-size-fits-all.
“There’s no magic shot,” Keele said, “and there is no magic pill.”
But many patients are willing to take the chance.
“I had tried the semaglutide for about four months and did not lose any weight at all,” McClanahand, a patient at Alliance Dermatology said. “I felt nauseated throughout the day. I had lots of indigestion.”
So, she switched to the tirzepatide.
“It has been night and day difference. I’m two months in and down 18 pounds.”
Meanwhile, Mettlen, a patient at Alliance, said she has tried just about everything to lose weight.
“I’ve done Keto,” she said. “My husband is diabetic, so I cook low sugar, high fiber and he can lose weight on that, I just gained.”
That’s why she turned to semaglutide injections.
“So, the first two months, I lost three to five pounds. And then the third month, I lost nothing,” Mettlen said. “So, it was a little discouraging. “They upped my dosage, and in this last month, I have lost almost 12 pounds.”
But it came with a risk.
“I have had a lot of side effects,” Mettlen said. “The first three months, I was miserable with indigestion, but I was losing weight finally and that was well worth it.”
“A lot of patients, even the ones that get nausea, they don’t discontinue it because of the nausea,” Keele said. “Constipation and/or diarrhea are fairly common side effects with the drugs – so it just depends on the patient.”
It’s not for everyone
Many doctors and pharmacists say some people shouldn’t consider it at all.
“These medications do come with a certain amount of side effects, thyroid tumors, pancreatitis,” said Eric Daume, the pharmacy manager at MediCenter.
According to the FDA, the agency has received adverse reports after patients used compounded semaglutide, saying patients should not use a compounded drug if an approved drug is available to treat a patient.
The FDA also just updated its labeling for Ozempic to include a warning about blocked intestines, a potentially fatal side effect.
Regarding the compounded versions, the FDA says patients and health care professionals should understand that the agency does not review those versions of the drugs for safety, effectiveness or quality.
However, many local medical professionals say they’re seeing success.
“Used appropriately with a health care team these medications can have dramatic results on certain patients,” Daume said.
That’s what’s driving so many people to give it a try.
“I was just embarrassed,” Mettlen said. “You are just kind of embarrassed, you definitely don’t want to wear a bathing suit and I’m like I am not wanting to wear anything that shows my legs or belly for sure.”
“I already feel so much better. I am pulling out the smaller clothes. My shorts are getting looser.”
McClanahand said she wanted to have energy again.
“I have to be healthier in order to keep up with my kids,” she said, “so I was ready to make that decision that I needed to do something different.”
‘Not reality’
The doctors and pharmacists who prescribe and compound the medications say it’s not magic. It’s not what is seen on social media.
“You see the TikToks that say, ‘the pounds just fall off and all I have to do is take this and it goes away,’” Pharmacist Abe Funk said. “That’s not reality.”
Kindal Al Arnaout, of Cape Girardeau County, was willing to try anything.
“I always did the yo-yo dieting,” she said. “Always yo-yo, you lose some, you gain it back and then some.”
Then she heard about Mounjaro and decided to give it a try.
“I loved it,” Al Arnaout said. “It made me feel good, I lost about 30 pounds within four months of taking it.”
The cost of the shots depends on where you get them from.
KFVS called around to spas and clinics in the Cape Girardeau area and found they range in price – anywhere from $60 to $400 a month depending on the dosages.
When Al Arnaout was taking the shots, she had a coupon for the name brand drug, so she could afford it.
“Once that coupon ran out,” Al Arnaout said, “it was $1,000 out of pocket.”
That’s when she switched to something she could afford – compounded semaglutide injections.
“I never lost any weight those four months of taking it,” she said. “I was miserable. You get nauseous, you’re just sickly feeling, you’re just off the whole entire day.”
Funk said it’s not a drug for everyone.
“Whether it’s the injection, whether it’s the compound, the tablet, it works wonderfully for some people and it doesn’t work at all for some people,” the owner of John’s Pharmacy in Cape Girardeau said.
John’s Pharmacy has seven locations, and they offer compounded semaglutide, but in the oral form.
“We take the commercially available Rybelsus tablet, which is semaglutide,” Funk said. “We crush it up, mix it with other ingredients and turn it into a suspension.”
“I think independent pharmacies are a part of the journey,” Daume said.
Know what you’re taking
MediCenter, according to its website, specializes in compounding semaglutide and tirzepatide.
They say through compounding, they can turn the medication into easy-to-take oral tablets that dissolve under the tongue.
If people get any of the medications from either MediCenter or John’s Pharmacy, the pharmacists there say they will know what they’re getting.
Meanwhile, Alliance Dermatology and EBO MD both use a pharmacy out of Knoxville, Tennessee, called The Compounding Pharmacy of America.
According to its website, Compounding Pharmacy of America is licensed to serve 32 states – including Missouri, Illinois, Kentucky and Tennessee.
We reached out to the pharmacy multiple times to ask about its compounding of these products, what ingredients it uses and how much it produces, but our calls and e-mails have not yet been returned or answered.
“They [Compounding Pharmacy of America] only use FDA approved ingredients,” Keele said, “and actually the ingredients they are getting is from the same supplier the manufacturers of the brand in medication uses.”
There are a couple of important things to know.
“By definition,” Funk said, “no compound will ever be FDA approved.”
And there are no generics available of these types of medications.
“If someone is advertising, they have those in the generic form, that is false,” Funk said. “The FDA has not approved any generic form for distribution.”
Legal action
In September, Eli Lilly, the maker of Mounjaro, took legal action.
According to the company, it cannot validate the safety or effectiveness of products claiming to contain tirzepatide, because it is not its own branded product.
Lilly filed lawsuits to stop the “unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro [tirzepatide] by medical spas, wellness centers, and compounding pharmacies.”
Lilly provided a statement to KFVS, saying in an email, “these entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.”
The company also said that products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy and are not FDA-approved like Mounjaro, and may expose patients to potentially serious health risks.
Novo Nordisk, the maker of Ozempic, Rybelsus and Wegovy, also took legal action over the summer.
The company initiated legal proceedings against medical spas, weight loss or wellness clinics and compounding pharmacies to cease and desist from false advertising, trademark infringement and unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.
The company said in a new release that these practices have created a high risk of consumer confusion and deception, as well as potential safety concerns.
The company also stated that the practice of selling compounded semaglutide medicines under Novo Nordisk trade names is unlawful and will not be tolerated.
“Our priority is to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines, and these actions are a direct reflection of that focus,” Doug Langa, executive vice president, North America operations and president of Novo Nordisk, said in a news release. “We believe it’s important to provide additional tools and education to support the proper use of our approved semaglutide products and create broad public awareness regarding the difference between our FDA-approved medicines and other products being labeled as semaglutide.”
You can read more about semaglutides from Novo Nordisk by clicking here.
Cracking down
The FDA has also recently cracked down on online sales of these medications, through warning letters sent to companies.
A quick web search shows there are still several sites selling the shots.
“There’s no such thing as an over-the-counter semaglutide,” Funk said “I have seen some online ads for that and that doesn’t exist in America, legally.”
Many of the medical experts interviewed for this story had concerns about where some local clinics are getting their injectables.
“There is a risk of knowing for sure what is actually going into that product,” Merriman said.
“That scares me,” Funk said. “I wouldn’t inject anything in my body if I didn’t know exactly what it was or where it came from.”
“If you are getting a drug that is normally $1,000 at the pharmacy and you are getting it for 60 bucks a month I would be very wary of where it is coming from,” Keele said. “Is this the real stuff or is this the salt version.”
The salt version is something the FDA warns against.
According to the FDA, it received reports that, in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate.
The agency said salt forms are different active ingredients than is used in the approved drugs, which contain the base form of semaglutide.
Trying to understand
“I would not look at these medications as a cure for obesity, or you take them and all of the sudden you’re down and you have a six pack, you look like a model and you’re on a magazine cover and you stop taking them and you’ll stay that way,” said Dr. Steven Finstad, an internal medicine physician at Saint Francis Healthcare Primary Care.
Finstad has battled with weight loss himself. He said he’s tried many of the same fads his patients have tried, and he’s working on his specialty in obesity medicine so he can help others.
“We now live in world that is calorie dense and nutrient poor,” he said. “Never in human history have you been able to go across the street and get a 2,000-calorie shake.”
Finstad said he hears story after story from patients who don’t know what to do.
“We’re having a lot of people come in who are struggling with weight,” he said, “and don’t understand why.”
Many of his patients are interested in the weight loss shots, and he said he prescribes those types of medications often.
“Some of the patients now on semaglutide are losing 15 percent with a once-a-week injections,” Finstad said. “Some of the patients on Mounjaro, or tirzepatide are losing 24 percent at 68 weeks. So, you are having a significant reduction in body weight. That gets mainstream attention because you’ll lose weight, and you can still go have a burrito and a chocolate shake.”
However, he, like other local physicians, said the medications are not for everyone.
“Anyone who is under a BMI of 27, the medications are not warranted for and if you start to lose weight, you lose weight in the wrong way,” Finstad said, “and you don’t need to lose weight, you’re going to lose muscle, bone and lean tissue. In the long term that will hurt you, instead of help you.”
So, what happens when people stop taking the medications?
“Your hormone levels go back up, your appetite goes back up and you don’t have the muscle and lean tissue to stave off the re-weight gain,” Finstad said. “You’ll gain the weight back and sometimes more.”
Which is why he said people still need to eat well and exercise while taking those medications, and work with a team of health professionals who can help you reach and maintain goals.
“We take that approach,” Finstad said, “instead of here’s the shot, go home, good luck.”
Other doctors and pharmacists agree with that sentiment – there is no magic cure.
“What’s important to know is that if you want to sit on your couch and eat your potato chips, and have your drink and not exercise, don’t do this…it’s a waste of money,” Funk said.
‘I’ve got hope now’
Al Arnaout spent a lot of money on the shots, but found they weren’t for her.
She ended up having bariatric surgery.
“I want a healthy life,” she said, “I want a long healthy life.”
She had the procedure in August, and Al Arnaout is already down 50 pounds.
“I need this for me,” she said.
She cautions anyone who may judge those considering any of these types of medications or procedures. She’s heard all the questions.
“Why didn’t you just go to the gym, why don’t you just eat right, why don’t you just make better decisions,” Al Arnaout said, “it’s not like that, it’s not like that at all.”
Other patients agree, saying they don’t see this as an easy way out. Instead it’s a way to jumpstart a healthier way of living.
“That’s what I saw in it,” Mettlen said. “I’ve got hope now.”
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