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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.|#shorts231
By Dani Blum
Leer en español
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.
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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.
Telehealth and social media are playing a significant role in driving demand for Ozempic, a prescription drug that treats Type 2 diabetes, experts told CNN. The current drug shortage has limited access for patients with diabetes who rely on it to control their blood sugar.
What drug is equal to Ozempic? ›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 a natural alternative to Ozempic for weight loss? ›- PhenQ – natural fat burner and appetite suppressant.
- KetoCharge – keto weight loss pill.
- Zotrim – herbal hunger reducer.
Mounjaro has been studied head-to-head against Ozempic. After 40 weeks, people taking it saw a better reduction in hemoglobin A1C levels (average blood sugar over 3 months) compared to Ozempic. And they lost more weight, too. Mounjaro is only approved to treat Type 2 diabetes for now.
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.
How much does Ozempic cost without insurance? ›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).
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.
There is "limited availability" of the 2 milligram solution, and the 0.25 milligram / 0.5 milligram, 2 milligram / 1.5 milliliters injection product will be discontinued, according to the FDA. In 2022, increased demand pushed Novo Nordisk's diabetes drug Ozempic and weight loss drug Wegovy (semaglutide) into shortage.
Can I get a 3-month supply of Ozempic? ›
With the Ozempic® Savings Card, you may PAY AS LITTLE AS $25b for a 1-month, 2-month, or 3-month supply for up to 24 months. To receive offer, prescription must be for a 1-, 2-, or 3-month supply.
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).
Is metformin an alternative for Ozempic? ›There are several medications available, Ozempic and metformin being two of them. Ozempic is a once-a-week injection, whereas metformin is an oral pill, usually taken twice a day. Both medications help control blood sugar; however, they work differently in the body.
Is Rybelsus or Ozempic 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.
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 Ozempic good for weight loss without diabetes? ›Ozempic isn't approved for weight loss. But because of how it works, some people taking Ozempic lose weight as a side effect. If you don't have diabetes, taking Ozempic for weight loss is considered an off-label use. Wegovy, a higher-dose version of Ozempic, is approved to help people manage their weight.
Is metformin or Ozempic better for weight loss? ›Ozempic has generally been shown to help people lose more weight than metformin, but everyone's experience is different, and weight loss is not guaranteed by either drug – nor is either drug FDA-approved for that purpose.
Which is better Trulicity or Ozempic? ›Cardiovascular benefit
Trulicity has been found to provide a 12% risk reduction. This includes people with heart disease or heart disease risk factors. Ozempic has been found to provide a 26% risk reduction. But this only includes people with established heart disease.
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 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.
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.
Is there a 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.
What if I can t afford my Ozempic prescription? ›How to Get Prescription Assistance. To find out what Ozempic prescription assistance programs might be available to you, apply online or call Simplefill today at 1(877)386-0206. One of our advocates will contact you within 24 hours to conduct a telephone interview.
Will health insurance cover Ozempic for weight loss? ›If your plan covers drugs for weight loss, it might include Wegovy but not Ozempic and Mounjaro in that category. They aren't FDA-approved for weight loss, so they often aren't covered for that use.
Will Medicare pay for Ozempic for weight loss? ›Ozempic, Wegovy and Mounjaro are not covered for weight loss under most Medicare and Medicaid programs.
Do you lose more weight with Ozempic or Mounjaro? ›As demonstrated above, tirzepatide (the active ingredient in Mounjaro) leads to more clinically significant weight loss and blood sugar reductions than semaglutide (the active ingredient in Ozempic).
Which is more expensive Ozempic or Mounjaro? ›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.
How does Mounjaro make you feel? ›Mounjaro can cause side effects. The most common side effects reported by patients were nausea, diarrhea, decreased appetite, indigestion, vomiting, constipation, and stomach pain.
Which is better Ozempic or Jardiance? ›
Jardiance has an average rating of 5.3 out of 10 from a total of 301 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 888 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.
Which is stronger Ozempic or Mounjaro? ›Mounjaro is a more effective drug than Ozempic. As demonstrated above, tirzepatide (the active ingredient in Mounjaro) leads to more clinically significant weight loss and blood sugar reductions than semaglutide (the active ingredient in Ozempic).
How can I get Mounjaro for weight loss? ›A licensed telehealth professional will evaluate your health. If they determine that Mounjaro may be right for you, they'll provide an electronic prescription. You can then order the medication through the service. The services also include coaching and other support to help you lose and manage your weight.
What is the best injection for weight loss? ›- Saxenda.
- Semaglutide.
- Ozempic.
- Wegovy.
Vertex has announced that it plans to begin clinical trials for encapsulated insulin-producing stem cells in the first half of 2023, The therapy had also previously been cleared for clinical trials in Canada, with an early clinical trial already ongoing.
Do people lose more weight on Trulicity or Ozempic? ›One head-to-head study compared Trulicity and Ozempic on how much they lowered hemoglobin A1C (HbA1C or A1C) — average blood sugar levels over 3 months. Ozempic was found to lower A1C more than Trulicity, and people taking it lost more weight.
Is there a generic 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.