Fake Ozempic putting users at risk — how to spot knockoffs

medicine

by mark laranilla

In the frenzied rush to lose weight, prescriptions for semaglutide drugs such as Ozempic, Wigovy, and Munjaro have skyrocketed.

Manufacturers are struggling to keep up with overwhelming demand, paving the way for compounding pharmacies to step in.

Compounding pharmacies are pharmaceutical companies that combine, mix, or modify ingredients to create tailored medicines for individual patients.

For example, you might make a medicine for a child who is allergic to a certain dye and needs a medicine without it.

Despite providing an important service, these pharmacies live in regulatory limbo with weak or inconsistent oversight, and a history of errors, some of them fatal. there is.

And now reports are emerging that compounders made Ozempic and other semaglutide drugs are causing severe or life-threatening overdoses in unsuspecting patients.

“We’ve been getting calls about some of these cases,” Jimmy Leonard, director of clinical services at the Maryland Poison Center at the University of Maryland School of Pharmacy, said recently. told WebMD. “We’ve had people suddenly overdose tenfold. Hey, were they sick?”

Increasing complexity of pharmacy issues

In 2012, a Massachusetts pharmacy shipped fungal-contaminated medications across the United States, which were then injected into patients’ spines and joints.

As a result, more than 750 people in 20 states developed serious fungal infections and 64 people died from the injections.

Pew Drug Safety Researcher From 2001 to 2019, they found 73 compound or potential errors associated with more than 1,562 adverse events, including at least 116 deaths.

Pew researchers also report that only 30% of states require pharmacies to report serious adverse events, and the actual number of deaths and adverse events is likely much higher.

In most cases, state Boards of Pharmacy are responsible for the day-to-day oversight of state-licensed pharmacies.

Only compounding pharmacies that register with the Food and Drug Administration as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act are subject to FDA oversight and inspection.

Also, when the FDA inspects compounding pharmacies, it sometimes finds very alarming circumstances.

The FDA reports: “The company observed problematic conditions in a number of inspections of its compounding facilities, including toaster ovens used for sterilization, pet beds near sterile compounding areas, and operators handling sterile medications with exposed skin where particles and bacteria could be scattered. .”

Semaglutide drug shortage

This is a windfall for compounding pharmacies, as semaglutide and many other drugs are currently in short supply.

Early this year, Reported by University of Utah Drug Information Service More than 300 serious drug shortages.

Drugs such as Adderall, cancer drugs such as carboplatin and cisplatin, anesthetics such as lidocaine and ketamine, and antibiotics such as amoxicillin are desperately in short supply in hospitals and other medical facilities.

counterfeit ozempic

However, compounding pharmacies manufacture drugs like semaglutide, often dispensing them in liquid vials and insulin syringes rather than pens, making it difficult to calculate the right dose for patients.

Additionally, the FDA is warning people that the ingredients in so-called “semaglutide” in pharmacy preparations may not be semaglutide but imitation salts such as semaglutide sodium or semaglutide acetate.

These counterfeit salt forms of semaglutide have not been proven safe or effective, and the FDA has not tested or approved them for use.

Just last month, This was reported by the Journal of the American Pharmacists Association. There were three cases of semaglutide overdose, two from a compounding pharmacy and one from an aesthetic spa.

Two patients self-administered 10 times the recommended dose, causing nausea, vomiting, and abdominal pain that lasted several days.

How to spot a fake Ozempic

In June, Novo Nordisk, the manufacturer of Ozempic, warned the public that “counterfeit Ozempic (semaglutide injection) pens have been discovered in the United States.”

The counterfeit product was “reportedly purchased at a retail pharmacy, and the company is actively investigating this report and working with the FDA to determine the source and distribution of the counterfeit pen.”

The drug company also provided tips to help consumers tell the difference between real and fake products. Genuine Ozempic pen:

Genuine Wegovy pen:

Counterfeit products can be identified by: