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Regulators are raising concerns about compounded semaglutide.
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(Video) Ozempic Is Hard to Find. Some Pharmacies Are Offering Unauthorized Alternatives.|#shorts
By Dani Blum
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When Carrie Davis found out that her health insurance wouldn’t cover Ozempic, she sought an alternate route to getting the diabetes drug, which is increasingly being used off-label for weight loss. Ms. Davis, 55, did not have diabetes, but had gained 50 pounds during menopause and developed hypothyroidism, she said, and was eager to lose weight.
After seeing someone claiming to be a doctor on TikTok saying he could help patients obtain a generic version of the medication, she reached out. After a few days and a brief video consultation with someone who introduced herself as a nurse practitioner, Ms. Davis had a prescription in hand. “It was really fast,” Ms. Davis said.
It took a week for the medication to arrive — a vial filled with a mauve liquid that was semaglutide, the doctor said, the same active ingredient as in Ozempic. She was told to inject it weekly, just as people who take Ozempic do. But her medication had been shipped to her home in Galveston, Texas, from a compounding pharmacy in Kentucky.
In the scramble to find Ozempic, patients are seeking out telehealth platforms, medical spas and compounding pharmacies for what some tout as “generic” versions of the drug. But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for compounding purposes, and a generic form of the drug approved by the Food and Drug Administration doesn’t exist, a Novo Nordisk representative wrote in a statement.
There are roughly 7,500 compounding pharmacies in the United States, according to the American Pharmacists Association. Compounding involves mixing and altering drugs, customizing them for patients with specific needs — for example, someone who is allergic to an ingredient in a medication might require a reformulated version.
Because the F.D.A.’s drug shortage website lists as Ozempic as “currently in shortage,” compounding pharmacies are allowed to buy semaglutide from pharmaceutical ingredient manufacturers and compound it into an injectable medication they dispense. They also often mix it with B vitamins or a metabolic compound called L-carnitine, which limited research has shown may contribute to weight loss. Some compounding pharmacies are distributing a different active ingredient altogether: semaglutide sodium, the salt form of semaglutide.
In recent weeks, regulators have raised concerns about semaglutide sodium, which is sometimes sold as a research chemical. Semaglutide sodium does not appear to meet standards for compounding in federal law, in part because the substance is not part of any F.D.A.-approved medication — and officials have expressed alarm at how widespread it is.
The F.D.A. does not vet compounded medications, and has not reviewed, approved or tested — for safety or effectiveness — the semaglutide drugs compounding pharmacies offer. Compounded semaglutide poses a higher risk to patients, as any compounded drug would, a representative from the agency said.
“There are a lot of great compounding pharmacies out there that take great patient care every single day,” said Betty Jones, compliance senior manager of accreditation and inspection programs at the National Association of Boards of Pharmacy. “But there are some of those bad actors.”
Regulators respond
At the end of April, the F.D.A. sent a letter to the National Association of Boards of Pharmacy, saying the agency was aware that compounders might be using salt forms of semaglutide. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements,” the letter read.
Functionally, when semaglutide sodium is dissolved in water, the sodium ion separates from the semaglutide molecule, leaving semaglutide and an extremely small amount of sodium, said Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding. But there isn’t data demonstrating whether semaglutide sodium is safe for consumers, or even whether it’s effective, said Mary-Haston Vest, system director of pharmacy with UNC Health.
In response to mounting questions about compounded semaglutide, the North Carolina Board of Pharmacy issued a statement forbidding compounding pharmacies to use salt forms of semaglutide. The West Virginia Board of Pharmacy issued its own warning on the topic. The Mississippi Board of Pharmacy also released a similar warning, writing that “drug manufacturers have become aware of the practice of using semaglutide salts for compounding and may choose to initiate legal proceedings to combat this practice.”
A representative from Novo Nordisk said the company is taking action, including but not limited to issuing cease-and-desist letters, against “entities that are engaging in the unlawful sale of compounded semaglutide, disseminating false advertising, and infringing its trademarks.”
“It’s a scary area,” said Dr. Andrew Kraftson, a clinical associate professor in the division of metabolism, endocrinology and diabetes at Michigan Medicine at the University of Michigan. “And I think it’s only going to get more thorny.”
Meeting a need
Compounding pharmacies are attempting to fill a crucial hole in the market, said Tenille Davis, a compounding pharmacist in Arizona. “They’re not trying to make a million bucks doing this. They’re trying to meet an intense, overwhelming patient and provider demand for this product.”
There are some guardrails in place. Under federal law, compounding pharmacies can compound drug products only with active ingredients that come from facilities registered with the F.D.A., Mr. Brunner said. And state boards of pharmacy license and inspect compounding pharmacies; the F.D.A. also inspects compounding pharmacies that it believes pose a safety risk. “The fact that it’s not F.D.A.-approved doesn’t automatically mean that it’s not safe,” Mr. Brunner said.
But it’s not clear how the vitamins or other additives pharmacies mix with semaglutide might interact, and compounding pharmacies are largely making “educated guesses” about how safe these combinations are, said Robin Bogner, a professor at the University of Connecticut School of Pharmacy and an expert on compounding. “While there are not known interactions,” Dr. Vest said, “this does not necessarily mean no interactions exist.”
‘Too good to be true’
Ms. Davis did not appear to have a negative reaction to the drugs she received, but she did switch to a different source for getting compounded semaglutide: a weight loss clinic that gets its medications from a local compounding pharmacy. The clinic required blood work, in-person appointments and stricter oversight than the doctor she found on TikTok had provided, she said, measures that made her feel more comfortable as a patient; the clinic also costs less. Both compounded drugs seemed to work, she said.
Some websites sell what they claim is semaglutide directly to consumers — no prescription, no oversight, just vials of the chemical, with wording on the label that the semaglutide is only meant for “research use.” There’s a critical difference between those sites and compounding pharmacies, Mr. Brunner said. The National Association of Boards of Pharmacy maintains a list of websites that sell fraudulent and unsafe medications, and patients should consider crosschecking to make sure they are not getting semaglutide through one of those channels, said Bill Cover, the associate executive director of state pharmacy affairs at the National Association of Boards of Pharmacy. And be wary of telehealth services that offer compounded semaglutide without a prescription or any input from a licensed doctor, Mr. Cover added. “If it’s too good to be true, it could potentially be a big red flag,” he said.
Dani Blum is a reporter for Well.
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FAQs
What are some alternatives to Ozempic? ›
Other GLP-1 agonists that are alternatives to Ozempic include Byetta, Victoza, Tanzeum, Trulicity, and Mounjaro.
What are over the counter alternatives to Ozempic? ›- PhenQ.
- PhenGold.
- TrimTone.
- LeanBean.
- PrimeShred.
PhenQ – This all-natural weight loss supplement offers almost the same benefits as Ozempic and other semaglutide drugs. It's also more versatile than Ozempic because aside from suppressing appetite, it also boosts metabolism to help patients burn more calories throughout the day.
Who is the new competitor of Ozempic? ›Mounjaro is a drug that has created particular buzz in the pharmaceutical space for its edge over Ozempic. Compared to its competitor, Mounjaro was found to aid in cutting weight in patients who have struggled with obesity by 22.7 percent.
Is there a cheaper alternative to Ozempic for diabetes? ›Is there a cheaper substitute for Ozempic? Victoza (liraglutide) is another GLP-1 agonist that is similar to Ozempic but is less expensive. Other diabetes medications are also much less expensive, such as metformin, glipizide, or insulin.
What works better than Ozempic for weight loss? ›Mounjaro demonstrated significant weight reduction across all three weekly doses (5 mg, 10 mg and 15 mg) compared to Ozempic 1 mg.
Why is Ozempic not covered by insurance? ›That said, when Ozempic is prescribed off-label for weight loss, it is often not covered by insurance. Why? Because the Affordable Care Act doesn't mandate that health insurers cover obesity or overweight medications or surgeries.
What happens when you stop taking Ozempic? ›As soon as someone stops taking the drug, their body fat and former appetite tend to return. Experts recommend working with a provider versed in obesity medicine to create a plan for improved lifestyle and long-term adherence to the drug.
Can you quit Ozempic cold turkey? ›For most people, stopping Ozempic cold turkey is not recommended. When to stop Ozempic is an individual decision you should come to with the help of your healthcare provider. If your health provider agrees it's time to stop taking Ozempic, they will provide you with instructions for tapering off your dose.
How to get Ozempic for weight loss cheap? ›People with private insurance will ultimately get Ozempic at a cheaper price. This could be as low as $25 for a month for a 1-, 2-, or 3-month supply, Oronsaye said. If paying out of pocket, you might be able to get it cheaper if your pharmacy takes discount cards, such as GoodRx.
Is there a generic for Ozempic? ›
There are currently no generic alternatives for Ozempic. Ozempic is covered by most Medicare and insurance plans, but some pharmacy coupons or cash prices could help offset the cost. Ozempic (semaglutide) is used to improve blood sugar control in adults with type 2 diabetes.
Why is Mounjaro better than Ozempic? ›Mounjaro works better to lower A1C compared to Ozempic
People receiving any dose of Mounjaro had a greater reduction in hemoglobin A1C (HbA1C or A1C) compared to people receiving Ozempic. A1C is your average blood glucose levels over 3 months. If you need more help lowering your A1C, Mounjaro can be a good choice.
A person can stay on Ozempic® so long as they are tolerating the medication and it is deemed appropriate by their treating provider. There is no specific time frame when someone should stop taking Ozempic as it is a medication that is intended for chronic (long-term) use.
What pill is the same as Ozempic? ›What Is Rybelsus? Rybelsus is essentially Ozempic in the form of a pill rather than an injection. Ozempic and Rybelsus are made by the same manufacturer, Novo Nordisk, and have the same active ingredient, semaglutide.
What is stronger than Ozempic? ›Wegovy is available at a higher dosage (2.4 mg weekly) than Ozempic. Compared to 1 mg of semaglutide, more people taking 2.4 mg reported side effects in clinical trials.
How do I get Ozempic for $25 a month? ›If you have private or commercial insurance, such as insurance you receive through an employer, you may be eligible to pay as little as $25 for a 1-, 2-, or 3-month prescription (maximum savings of $150 per 1-month prescription, $300 per 2-month prescription, or $450 per 3-month prescription).
Can metformin replace Ozempic? ›Ozempic is often given when metformin—which is first in line to be prescribed— doesn't work for someone with type 2 diabetes mellitus. Healthcare professionals also prescribe metformin and Ozempic off-label to treat overweight and obesity as part of a holistic approach to weight care.
Is Ozempic covered by Medicare? ›Traditional Medicare does not currently cover these drugs, which include brand names like Novo Nordisk's Ozempic and Wegovy, for weight loss. There was a push in Congress in 2021 to expand coverage to include the use of these drugs for weight loss, though that did stall.
What does Ozempic do to your face? ›“Ozempic face” is a term for common side effects of the type 2 diabetes medication semaglutide (Ozempic). It can cause sagging and aging of facial skin. A doctor may recommend lifestyle modifications or facial fillers to treat these effects.
Do you regain weight after stopping Ozempic? ›Some individuals may actually gain more weight after stopping an obesity drug than they initially lost, Conde-Knape added. Studies have similarly shown weight rebound in people who stop taking Ozempic.
Can you lose belly fat on Ozempic? ›
Will Ozempic or Wegovy reduce belly fat? The answer appears to be yes. That Novo Nordisk-funded study of almost 2,000 overweight or obese adults without diabetes also found their visceral fat — the type that accumulates in the belly — was reduced from baseline with semaglutide, along with their total fat mass.
What can you do if you can t afford Ozempic? ›Ozempic® is a prescription medication. Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.
How much weight can you lose in a month with Ozempic? ›How much weight will I lose with Ozempic? About a third of people who take Ozempic for weight loss will lose 10% or more of their body weight. Most people should expect to lose at least 5% of their starting body weight when using Ozempic for weight loss.
What is the generic for Ozempic for weight loss? ›Semaglutide is the generic name for both Wegovy and Ozempic, which are made by Novo Nordisk. Wegovy is approved for weight loss, while Ozempic is used to treat people with diabetes. Both drugs are given by weekly self-injections, though future generations might be available as pills.
Can you stay on Ozempic for life? ›Experts said they consider Ozempic and Wegovy to be lifelong medications.
What is the biggest side effect of Ozempic? ›Semaglutide (Ozempic, Wegovy, Rybelsus) can cause side effects that some people are unable to tolerate. Following dosing guidelines can help manage these side effects. Nausea, vomiting, and diarrhea are the most common semaglutide side effects.
Can you still lose weight after stopping Ozempic? ›Drugs like Wegovy and Ozempic lower a person's appetite to help with weight loss, but experts say the weight can come back if they're no longer used.
What happens if you stop taking Ozempic for a week? ›Robert Gabbay, chief scientific and medical officer of the American Diabetes Association, said in an interview with the Times. The feelings of suppressed appetite will start to go away, and people will start to feel hungry much like they did before starting Ozempic, doctors explain.
Can Ozempic be taken indefinitely? ›“GLP-1 medications [like Ozempic] are designed to be taken long-term,” explains Dr. McGowan.
What is the King Kong of weight loss drugs? ›Is there a new 'King Kong' of weight-loss drugs? Semaglutide, a drug that mimics a hormone called glucagon-like peptide-1 (GLP-1) to target areas of the brain that regulate appetite and food intake, has grown in popularity in recent months as an effective weight-loss treatment.
Can your family doctor prescribe Ozempic for weight loss? ›
Providers (doctors, nurse practitioners and physician assistants) can prescribe either Ozempic ("off label") or Wegovy for weight loss, but insurance companies will usually only cover these medications for their FDA-approved uses (Ozempic for only diabetes and Wegovy for only medical obesity treatment).
How do you get a Rx for Ozempic for weight loss? ›Getting Ozempic®
Get a prescription from your HCP: The first step is to get a prescription from your HCP. They will provide you with a prescription that you can take to your local pharmacy. Purchase from a local pharmacy: Once you have your prescription, you can purchase Ozempic® from your local pharmacy.
Generic Semaglutide is 8 times cheaper than its branded versions. You can get it for only $149 per 6-week supply from Semaspace.com. And you can even get free shipping and an injection kit by using the promo code 50OFF for your first purchase.
How long until Ozempic is generic? ›DrugPatentWatch® Generic Entry Outlook for Ozempic
Ozempic was eligible for patent challenges on December 5, 2021. By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2031. This may change due to patent challenges or generic licensing.
If you qualify for insurance coverage, Ozempic can cost as little as $25 for a monthly supply. However, without insurance, Ozempic costs around $892.06 per month, on average (NovoCare-a, 2022).
Which is better Ozempic or metformin? ›Ozempic and metformin help most people to lower their average blood sugar levels (as measured by an A1c blood test), and these effects are quite significant. Clinical trials have established that (at its maximum dose) metformin can help decrease A1c by 1.5%, while an average dose of Ozempic can decrease A1c by 1.4%.
Which is safer Ozempic or Mounjaro? ›Mounjaro is more effective for weight loss and blood sugar improvements than Ozempic. However, studies have shown that Ozempic has a better safety profile than Mounjaro, with more people stopping Mounjaro due to side effects and other adverse events.
Is Mounjaro or Ozempic cheaper? ›The average out-of-pocket cost for Mounjaro is about $1,100 per month, while the average out-of-pocket cost for Ozempic is around $1,000 per month.
Who is eligible for Mounjaro? ›Mounjaro® (tirzepatide) may be prescribed if you have type 2 diabetes. FORM physicians may also choose to prescribe Mounjaro if you have a BMI of 30 or higher or 27 or higher with weight-related conditions, and you have not been successful in losing weight or maintaining weight loss with lifestyle changes alone.
What foods to avoid on Ozempic? ›It is recommended that you take Ozempic before meals, rather than after, to minimise any potential side effects from eating high-fat or high-sugar foods. Foods high in fat or sugar include candy, ice cream, doughnuts, processed meats, french fries, fried chicken, any other fried foods, crisps and other fatty snacks.
Does Ozempic speed up your metabolism? ›
Am I Eligible? Ozempic® (semaglutide): It's one of several GLP-1 medications that are best known for their ability to help patients with type 2 diabetes control blood sugar—but the drug is also effective in helping those with obesity or overweight improve their metabolic health and lose weight.
What is the best injection for weight loss? ›- Saxenda.
- Semaglutide.
- Ozempic.
- Wegovy.
Possible Ozempic alternatives include Bydureon (exenatide), Victoza (liraglutide), Mounjaro (tirzepatide), Tanzeum (Albiglutide), and Trulicity (dulaglutide).
What is a natural alternative to Ozempic? ›PhenQ – This all-natural weight loss supplement offers almost the same benefits as Ozempic and other semaglutide drugs. It's also more versatile than Ozempic because aside from suppressing appetite, it also boosts metabolism to help patients burn more calories throughout the day.
What is the sister drug to Ozempic? ›It's correct that Wegovy and Ozempic are two names for the same drug: semaglutide.
What is the new alternative to Ozempic for weight loss? ›- PhenQ: Best Ozempic Alternative Overall.
- Zotrim: Herbal Appetite Suppressant.
- Altai Balance: Improve Blood Sugar Control.
Jardiance has an average rating of 5.3 out of 10 from a total of 302 ratings on Drugs.com. 40% of reviewers reported a positive effect, while 43% reported a negative effect. Ozempic has an average rating of 5.8 out of 10 from a total of 899 ratings on Drugs.com.
Is Trulicity the same as Ozempic? ›Is Ozempic the same as Trulicity? Both Ozempic and Trulicity are GLP-1 medications that are indicated for the treatment of type 2 diabetes. However, Ozempic has also been approved by the FDA to support chronic weight management. Trulicity is only approved for the treatment of type 2 diabetes in adults.
Is Ozempic or Rybelsus better for weight loss? ›Both Ozempic and Rybelsus are equally efficient in reducing blood sugar levels and shedding pounds. There is no research directly contrasting Rybelsus and Ozempic.
How can I get Mounjaro for weight loss? ›To get Mounjaro for weight loss, you will need to speak to a board-certified doctor to begin the evaluation process and complete any necessary lab tests. Although Mounjaro can promote weight loss, it is a medication to treat type 2 diabetes.
Is there a better medication than Ozempic? ›
Bydureon and Byetta are typically prescribed to people as a second-line treatment after other medications haven't worked (the same is true of Ozempic). They are used in addition to diet and exercise, and can be prescribed on their own or with other diabetes medications such as metformin (Bridges, 2022).
Is Ozempic available in pill form? ›Rybelsus is essentially Ozempic in the form of a pill rather than an injection. Ozempic and Rybelsus are made by the same manufacturer, Novo Nordisk, and have the same active ingredient, semaglutide.
Is metformin as good as Ozempic? ›Does Ozempic work better than metformin? Because Ozempic and metformin work in different ways, neither necessarily works better than the other. Depending on the dose, either metformin or Ozempic may lower blood sugar levels more than the other drug.
Is hair loss a side effect of Ozempic? ›While Ozempic does not list hair loss as a side effect of the drug, according to NBC, a clinical trial testing the effectiveness of Ozempic and WeGovy for weight loss found that 3% of patients experienced hair loss as a side effect of the treatment compared to 1% who received a placebo.