Regulators are alarmed as the high demand for Ozempic to help in weight loss has contributed to shortages that some health providers are remedying by prescribing generic or compounded versions of the drug.
Drugs like Ozempic containing the active ingredient semaglutide were first developed to help manage Type 2 diabetes. Yet it was soon discovered that the injectable medication yielded some astounding results for weight loss, as The Dallas Express reported.
While potentially beneficial for treating what has become a nationwide obesity epidemic affecting both adults and children, injections of semaglutide are known to carry certain risks, including kidney problems, vision changes, gastrointestinal issues, and thyroid cancer.
As The Dallas Express reported, this has led to some medical experts warning against using these drugs for weight loss.
Despite these warnings, Ozempic and similar medications are trending among the American public, from those looking to shed a few pounds to others looking to drop a significant amount of weight.
As 55-year-old Carrie Davis from Galveston recently told The New York Times, she was somewhere in between these two groups.
Davis had recently gained 50 pounds and was eager to lose weight. Since her health insurance company would not cover the high cost of Ozempic — as is often the case — Davis turned to a telehealth provider she found on TikTok.
Davis was quickly given a prescription for what the doctor explained was a generic form of Ozempic. Yet the Food and Drug Administration (FDA) has not approved any generic forms of the drug, according to The New York Times.
Moreover, the pharmaceutical company behind Ozempic, Novo Nordisk, does not supply semaglutide for compounding purposes.
Licensed pharmacists in compounding pharmacies are allowed to mix, alter, or reassemble drugs in order to adjust medications to patients’ needs, such as if a patient has an allergy or requires a different strength. Yet compounds are also permitted if a drug is facing a shortage, which is the case for semaglutide.
Compounding pharmacies are thus buying semaglutide and mixing it with vitamins or other metabolic compounds that promote weight loss. Yet some are resorting to a salt form of semaglutide, called semaglutide sodium, which has not been approved by the FDA because it is registered as a research chemical.
Of course, as Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding, told The New York Times, “The fact that it’s not F.D.A.-approved doesn’t automatically mean that it’s not safe.”
As The Dallas Express reported, several drugs are currently in short supply across the U.S. for various reasons related to pharmaceutical decision-making, disruptions to the supply line, and high consumer demand.
High demand for weight loss drugs containing semaglutide and the prescribing of such medications to consumers by telehealth companies, as in the case of Davis, has helped drive the current shortage.
Davis told The New York Times that she did not have a bad experience with the compounded semaglutide injectable she received from the doctor on TikTok. She reported it having worked as expected and has not suffered any negative side effects.
But she did switch to a local weight loss clinic as a prescriber which works directly with a compounding pharmacy and regularly monitors her health through in-person appointments.
While compounded medications are not monitored by the FDA, a representative told The New York Times that they generally pose a higher risk to patients than regular medications.
“There are a lot of great compounding pharmacies out there that take great patient care every single day,” Betty Jones, a compliance senior manager at the National Association of Boards of Pharmacy, told The New York Times. “But there are some of those bad actors.”
The pharmaceutical boards of some states have taken action to either prohibit or warn against using semaglutide salt to make compounded medications, including West Virginia, North Carolina, and Mississippi.
Novo Nordisk also reported that it is taking action against “the unlawful sale of compounded semaglutide, disseminating false advertising, and infringing its trademarks,” according to its website.
