Pharmacies offering unauthorized Ozempic alternatives amid shortage of weight loss drugs

Pharmacies are offering unauthorized Ozempic alternatives amid shortages of the weight loss drug.

Pharmacies, beauty clinics and rogue telehealth sites mix a cocktail of chemicals to mimic the fat-loss injection, according to the Food and Drug Administration (FDA).

Ozempic and Wegovy, which have grown in popularity in recent years, use the active ingredient semaglutide, a compound made by Novo Nordisk.

Because no generic form of the drug exists, some pharmacies are trying to make their own version using salts, which the FDA has said is unsafe.

A handful of pharmacies dispense another active ingredient called semaglutide sodium, the salt form of semaglutide

A handful of pharmacies dispense another active ingredient called semaglutide sodium, the salt form of semaglutide

Novo Nordisk, the maker of Ozempic, does not sell semaglutide for compounding — when drugs are modified to meet patients’ specific needs, such as an allergy to an ingredient.

And an FDA-approved generic form of the drug does not exist.

Ozempic is currently listed on the FDA drug shortage website, which means compounding pharmacies can get semaglutide from manufacturers of pharmaceutical ingredients and mix it into an injectable drug that they can self-administer.

It is often mixed with B vitamins or the metabolic compound L-carnitine, which small amounts of evidence have suggested could aid weight loss.

And a handful of pharmacies dispense another active ingredient called semaglutide sodium, the salt form of semaglutide.

Regulators in states like North Carolina and Mississippi have warned against the use of semaglutide sodium, which may be sold as a research chemical.

The ingredient is not in any FDA-approved drug and does not appear to meet preparation standards in federal law.

The FDA is not evaluating semaglutide drugs that compounding pharmacies dispense.

An FDA official told The New York Times that patients are more at risk if they take the compound semaglutide.

Betty Jones, compliance senior manager of accreditation and inspection programs at the National Association of Boards of Pharmacy, told The New York Times, “There are a lot of great compounding pharmacies out there taking great patient care every day.

“But there are some of those bad actors.”

Dr. Shauna Levy, an assistant professor of bariatric surgery at Tulane University in New Orleans who serves on the American Board of Obesity Medicine, previously told, “I know patients are desperate to use Wegovy to help with weight loss. , but this is not a good or safe way to access the medication.

“There’s no generic version of Wegovy, and there won’t be any for a while.”

The FDA sent a letter to the National Association of Boards of Pharmacy in late April saying the agency was aware that formulators were using salt forms of semaglutide.

It read, “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet the requirements of federal law.”

There are no data showing whether semaglutide sodium is safe or effective for patients, Mary-Haston Vest, system director of pharmacy at UNC Health, told The New York Times.

The North Carolina Board of Pharmacy banned pharmacies of the use of salt forms of semaglutide in April, while the West Virginia and Mississippi Boards of Pharmacy issued warnings.

Carrie Davis, 55, gained 50 pounds during menopause and developed an underactive thyroid known as hypothyroidism.

Her health insurance wouldn’t cover Ozempic, so she looked for an alternative route to get the drug off-label.

She came across someone claiming to be a doctor on TikTok who offered to give patients a generic form of the medication.

A few days later, after a quick video consultation with someone claiming to be a nurse specialist, Mrs. Davis had a prescription in her hands.

The drug was shipped from a compounding pharmacy in Kentucky and came in vials of purple liquid that the doctor said was semaglutide, the active ingredient in Ozempic.

She did not get a negative reaction from the drug, but went to another supplier for compound semaglutide.

Her new clinic calls for blood tests, in-person appointments and stricter supervision than the TikTok doctor, which made her feel safer. Both drugs seemed to work, Ms. Davis said.