The alarming surge in counterfeit and compounded semaglutide

Michael Bartlett

By Michael Bartlett

Posted on April 10th, 2024

Because of surging demand for Ozempic as a weight-loss treatment, fake versions of the injection pens have been discovered in the U.S. However, because counterfeit semaglutide can pose serious health dangers, consumers should proceed with caution when purchasing the drug.

Counterfeit versions of Ozempic, which contain the same active ingredient as the weight loss drug Wegovy, semaglutide, have been a growing concern for regulators. According to the FDA, thousands of counterfeit units of Ozempic injections have been discovered in the legitimate supply chain and seized, but some knockoff products may still be on the market. Novo Nordisk, the manufacturer of the original drug, which owns the patent on semaglutide, is working alongside the FDA to test the seized drugs. The agency is warning wholesalers, pharmacies, healthcare practitioners, and patients to check the labels of their products for counterfeit units and report suspect products.

At the end of 2023, the FDA announced a thorough investigation into counterfeit Ozempic, which was found in the country's drug supply chain. It is worth noting that the needles, as well as the packaging, labeling, and prescription information, were also counterfeit. With the rising popularity of GLP-1 receptor agonists and the future shortages for many of these drugs, it comes as no surprise to see counterfeit products entering the market. Ozempic knockoffs are labeled with lot number NAR0074 and serial number 430834149057. The FDA is aware of five adverse side effects from this lot, which are consistent with known common adverse reactions to authentic Ozempic, namely:

  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • constipation

Since the needles from the seized products were also counterfeit, they may not be sterile. Unsterile needles may cause infection, which is particularly concerning for people with diabetes, who are more prone to developing infections and may take longer to heal. To make sure they are buying genuine Ozempic, patients should use a valid prescription at a state-licensed pharmacy. Furthermore, they should check the injection pen for signs of falsification. These are the features patients should pay attention to when trying to distinguish genuine Ozempic from counterfeit medication:

  • Authentic needles: They have a transparent inner cover and a paper tab that states "NovoFine Plus" and the needle lot number. The paper tab's blue area should only show the lot number.
  • Counterfeit needles: They have a transparent blue inner cover and a paper tab stating "NovoFine" rather than "NovoFine Plus" and is imprinted with the Ozempic product carton lot number. The blue area of the paper tab contains more information than the lot number.

Compounded semaglutide, not tested or approved by the FDA

The mixing and combining of ingredients to make a specific drug is known as compounding. It is a legal way for patients to obtain medications suitable for their needs if a certain brand is out of stock. Nevertheless, the FDA warned some pharmacies across the country that were using unapproved forms of semaglutide or improperly compounding it.

The federal agency has raised concerns that patients can experience unexpected side effects if they use compounded semaglutide, which may be made with salt-based semaglutide forms. These are different from the active ingredient in Ozempic and Wegovy. "Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective," says the FDA. The presence of high sodium levels in the body can lead to high blood pressure, a significant risk factor for heart attacks and strokes.

Novo Nordisk is the only FDA-approved manufacturer of semaglutide. The company stated that it does not sell the active ingredient to compounding pharmacies. In January 2024, the FDA issued a warning to consumers about drugs marketed as "semaglutide" that may contain semaglutide sodium and acetate. The agency had received reports of adverse effects from compounded semaglutide and does not recommend that patients use these versions of the drug if they can purchase the brand-name medication.

Finally, Novo Nordisk has announced that it is pursuing legal proceedings against two compounding pharmacies, Wells Pharmacy, and Brooksville Pharmaceuticals, for selling adulterated and misbranded compounded drugs that claim to contain semaglutide. The pharmaceutical manufacturer has filed a total of 12 lawsuits against clinics, med spas, and compounding pharmacies nationwide that claim to offer semaglutide.

File your Ozempic stomach paralysis claim with the assistance of our diligent attorneys

Individuals who used Ozempic, Wegovy, or Rybelsus and now struggle with gastroparesis, also known as stomach paralysis, might be entitled to financial compensation, as Novo Nordisk failed to warn of this serious, often irreversible adverse effect. With over 35 years of experience in defective drug cases, our attorneys will gladly evaluate your situation to determine whether you qualify to file a claim with the manufacturer if you were harmed by this medication.

To initiate the legal process, you will only have to provide our legal team with evidence of your use of Ozempic, Wegovy, or Rybelsus and your medical records with your stomach paralysis diagnosis. After a thorough assessment of your documents, we will let you know whether you are eligible to file a claim. If you are, our skilled attorneys will go to great lengths to make sure you receive the maximum compensation available for your physical and emotional distress.