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Regulators express concern about complex semaglutide.
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When Carrie Davis found out her health insurance wouldn't cover herOzempic, was looking for an alternative way to obtain an antidiabetic drug that is increasingly used off-label for weight loss. Mrs. Davis, 55, was not diabetic, but gained 50 pounds during menopause and developed hypothyroidism, and desperately wanted to lose weight.
After seeing someone on TikTok claiming to be a doctor who could help patients get a generic version of the drug, she contacted him. After a few days and a short videoconsultation with a person who introduced herself as a specialist nurse, Mrs. Davis had a prescription in her hands. “It was really quick,” said Mrs. Davis.
The medicine took a week to arrive - a vial filled with a mauve liquid that was semaglutide, the doctor said, the same active ingredient found in Ozempic. She was told to inject every week like people who take Ozempic. But her medication was shipped to her home in Galveston, Texas from a pharmacy in Kentucky.
In the fight to find Ozempic, patients are searching telehealth platforms, medical spas and pharmacies for what some call "general"drug versions. 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 does not exist, a Novo Nordisk representative said in a statement.
According to data, there are approximately 7,500 pharmacies in the United StatesAmerican Association of Pharmacists. Mixing involves mixing and modifying drugs, tailoring them to meet the needs of patients with specific needs - for example, a person who is allergic to an ingredient in a drug may need a reformulated version.
Because the FDA drug shortage website lists Ozempic as "currently out of stock," pharmacies can purchase semaglutide from pharmaceutical ingredient manufacturers and combine it into the injectable drug 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 compound pharmacies distribute a completely different active ingredient: sodium semaglutide, semaglutide salt.
In recent weeks, regulators have raised concerns about sodium semaglutide, which is sometimes marketed as a research chemical. Sodium semaglutide appears to fall short of preparation standards under federal law, in part because the substance is not part of FDA-approved drugs - and officials are sounding the alarm about its prevalence.
The FDA does not test compound drugs and has not reviewed, approved, or tested semaglutide drugs offered by pharmacies for safety or effectiveness. The combination semaglutide poses a greater risk to patients than any combination drug, an agency representative said.
"There are many great pharmacies out there that provide excellent care to patients every day," said Betty Jones, senior manager of accreditation and inspection compliance at the National Association of Boards of Pharmacy. "But there are some of those bad actors."
Regulators are responding
In late April, F.D.A.sent a letterto the National Association of Boards of Pharmacy, saying the agency was aware that formulators could use semaglutide in salt form. "We are not aware of any basis for drug combination using these semaglutide salts to meet federal regulatory requirements," the letter reads.
Functionally, when semaglutide sodium dissolves in water, a sodium ion separates from the semaglutide molecule, leaving semaglutide and a very small amount of sodium, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding. But there is no data showing whether sodium semaglutide is safe for consumers or even effective, said Mary-Haston Vest, system director of pharmacy at UNC Health.
In response to increasing questions about the compound semaglutide, the North Carolina Board of Pharmacy has issued a statementto prohibitinducing pharmacies to use semaglutide salt. Issued West Virginia Board of Pharmacyhis own warningabout the topic. The Mississippi Board of Pharmacy also has onesimilar warning, writing that "drug manufacturers have become aware of the practice of using semaglutide salts in compounding and may take legal action to combat this practice."
A Novo Nordisk representative said the company is taking action, including issuing warning letters, among other things, against "entities involved in the illegal sale of compound semaglutide, dissemination of false advertising and trademark infringement."
"It's a scary area," says Dr. Andrew Kraftson, clinical associate professor in the Department of Metabolism, Endocrinology and Diabetes in Michigan Medicine at the University of Michigan. "And I think it's only going to get harder."
Satisfying a need
Blending pharmacies are trying to fill a critical gap in the market, said Tenille Davis, an Arizona-based compounding pharmacist. "They're not trying to make a million dollars out of it. They are trying to meet the intense, overwhelming demand from patients and suppliers for this product.
Several protective barriers have been installed. Under federal law, pharmacies can only combine drugs with active ingredients from FDA-registered facilities, Brunner said. And state pharmaceutical licensing boards and control connecting pharmacies; The FDA also inspects pharmacies it believes pose a safety risk. "Just because it's not FDA approved doesn't automatically mean it's not safe," said Brunner.
But it's not clear how the vitamins or other additives that pharmacies mix can interact with semaglutide, and compounding pharmacies largely make "educated guesses" about how safe these combinations are, said Robin Bogner, a professor from the University of Connecticut School of Pharmacy and scientist. connection expert. "Although no interactions are known," said Dr. Vest, "this does not necessarily mean no interaction."
'Too good to be true'
Ms. Davis did not seem to have had any adverse reactions to the medications she was receiving, but she changed her source of sourcing the compound semaglutide: a weight loss clinic that receives the medication from a local pharmacy. The clinic required blood tests, in-person visits, and closer supervision than the doctor she found on TikTok took measures to make her feel more comfortable as a patient; the clinic is also less expensive. She said both combination medications seemed to be working.
Some websites sell what they claim to be semaglutide directly to consumers - over the counter, unsupervised, just vials of the chemical, with text on the label stating that semaglutide is for "research use" only. There is a major difference between these sites and connecting pharmacies, said Brunner. The National Association of Pharmaceutical Chambers conducts awebsite listthat sell fraudulent and dangerous drugs, and patients should consider cross-checking to ensure they are not getting semaglutide through one of these channels, said Bill Cover, deputy executive director for and beware of telehealth services that offer compound semaglutide over-the-counter or any input from a licensed physician, Mr. Cover added. "If it's too good to be true, it could be a big red flag," he said.
Dani Blum is a reporter for Well.
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