The FDA warns of the risks using counterfeit or compounded semaglutide may entail

Michael Bartlett

By Michael Bartlett

Posted on April 12th, 2024

Due to the surge in counterfeit and compounded semaglutide, the active ingredient in the diabetes and weight loss drugs Ozempic, Wegovy, and Rybelsus, the FDA issued a safety alert regarding the health risks using these versions may imply.

Belonging to a drug class known as GLP-1 receptor agonists, semaglutide was approved by the FDA for the treatment of diabetes in 2017 and for weight loss in 2021. There are currently three drugs containing this active ingredient on the market, all of which are manufactured by Novo Nordisk, specifically Ozempic, Wegovy, and Rybelsus. The pharmaceutical manufacturer owns the patent for semaglutide, and therefore, no other company has the right to use, make, or sell the substance. While Ozempic and Rybelsus are used as diabetes treatments, Wegovy promotes weight loss. All three drugs are FDA-approved.

However, because semaglutide was found to cause stomach paralysis in some users at the end of 2023, there is now a shortage of the drug across the country. For this reason, there has recently been a surge in counterfeit and compounded semaglutide. The FDA warns people who may have a difficult time accessing the medication they need of the dangers of using these versions. Counterfeit Ozempic usually contains insulin glargine, which is a different substance than semaglutide, and the needles of knockoff versions may not be sterile. This increases the risk of infection, which people with diabetes are more vulnerable to developing.

When it comes to compounded semaglutide, the FDA has received adverse effect reports after patients used it. In some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. These salt forms are different active ingredients than those present in the approved drugs. The FDA advises that patients should not use a compounded drug if an approved version is available. Patients and healthcare professionals should know that the agency does not review compounded versions for effectiveness, safety, or quality. Consequently, there may be significant health risks associated with compounding.

Novo Nordisk provides several tips on how to recognize counterfeit Ozempic

The risks of using counterfeit semaglutide are patients not receiving proper treatment and patients experiencing severe adverse reactions, such as nausea, abdominal pain, vomiting, diarrhea, and constipation. To avoid purchasing knockoff semaglutide, you should make sure you buy your medication only from state-licensed pharmacies. Furthermore, you should pay attention to the following:

  • spelling mistakes on labels
  • different colors on boxes
  • missing National Drug Code
  • poor quality labels
  • errors on dose counters and buttons

According to Novo Nordisk, medication purchased online or in person from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, improperly stored and transported, contaminated, ineffective, or unsafe. Buying and using counterfeit, illegal, and unapproved drugs from in-person or online unlicensed or foreign sources may endanger patients' health. The manufacturer offers a series of tips on how to spot fake Ozempic, as this is the only semaglutide-containing drug that has been counterfeited to date.

Genuine Ozempic injection pens have the following features:

  • they do not increase in length or extend when setting the dose
  • the dose dial window shows only the intended doses, specifically: on the pen that delivers 0.25/0.5 mg doses, it only shows -0-, 0.25, and 0.5 once dialed up to the intended doses; on the pen that delivers 1 mg dose, it only shows -0- and 1 mg; and on the pen intended to deliver 2 mg dose, it only shows -0- and 2 mg
  • authentic Ozempic pens are currently available in these configurations: 0.25/0.5 mg pen, 1 mg pen, and 2 mg pen
  • the box containing the authentic medication includes four needles that attach directly to the injection pen, except the 0.25/0.5 mg dose carton, which has six needles

Counterfeit Ozempic injection pens may have one or more of the following features:

  • a counterfeit pen may be identified based on the scale extending out from it when setting the dose
  • the label on a knockoff pen could be of poor quality and may not adhere well to it
  • a counterfeit carton may have spelling mistakes on the front of the box, such as "1pen" without a space between "1" and "pen"
  • a counterfeit carton may not include the tamper-resistant/perforation
  • the batch number on a counterfeit box may not correspond to the product strength written on the same box and pen

Even though certain drugs, including semaglutide, are in short supply and patients are having difficulty obtaining their medication, the FDA urges people to obtain prescription drugs only from state-licensed pharmacies, where the agency and state authorities can assure the quality of drug manufacturing, packaging, distribution, and labeling. The FDA encourages healthcare professionals, patients, and compounders to report adverse effects or quality problems to the MedWatch Adverse Event Reporting program by:

  • completing and submitting the report online or
  • downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

Quality legal assistance for patients with stomach paralysis caused by using Ozempic, Wegovy, or Rybelsus

If you used Ozempic, Wegovy, or Rybelsus as prescribed by your doctor and developed stomach paralysis, also known as gastroparesis, you might be entitled to financial compensation from the manufacturer. With over 35 years of professional experience pursuing defective drug cases, our skilled attorneys are ready to offer you the legal assistance you need. To initiate the process, you will only have to provide our law firm with evidence of your semaglutide use and your medical records stating your stomach paralysis diagnosis.

After a careful and thorough assessment, our attorneys will determine whether you qualify to file a claim with Novo Nordisk. If you do, we will promptly start working on your case with minimal involvement from you, as we understand that having stomach paralysis can entail serious physical and emotional distress. Our compassionate legal team will gladly take care of the most complex and demanding aspects of the process on your behalf. Eventually, if our endeavors are successful, you will receive the financial compensation available for your suffering.