The Best Tips to Identify a Fake Semaglutide Injection Dr. Jamie Velazquez, December 30, 2023August 6, 2024 Follow on LinkedInTable of ContentsUnderstanding Semaglutide’s Many FunctionsVisual Inspection of Packaging to Identify Fake SemaglutidePackaging AnomaliesLabeling DiscrepanciesAssessing the Physical Product to Identify Fake SemaglutideAppearance of the Injection PenLiquid Consistency and ColorVerification Processes to Identify Fake SemaglutideChecking Authenticity with ManufacturerVerifying Compounded ProductsSafety and Quality of Online SemaglutideVerifying Online PharmaciesPharmaceutical Regulations and StandardsDirections for Use: Identifying Fake SemaglutideSources Discover expert tips for spotting fake semaglutide injections. Semaglutide, is currently marketed under two brand names, Ozempic (Type 2 Diabetes) and Wegovy (Weight Loss). It is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that helps regulate blood sugar levels by stimulating insulin production and reducing glucose production in the liver. For weight loss, semaglutide works by reducing appetite and slowing gastric emptying. Semaglutide is administered as a subcutaneous injection and is available in a pre-filled pen.1 Unfortunately, fake semaglutide products have emerged in the market, posing a significant risk to patients. These fake products may contain incorrect doses, incorrect salt form, or no active ingredient at all, which can lead to serious health complications. There have even been reports of insulin pens being relabeled as semaglutide, leading to hospitalizations and seizures, due to low blood sugar levels. The scarcity of semaglutide has prompted health spas, online pharmacies, and wellness companies to introduce compounded versions of semaglutide at significantly reduced prices, as well. These enterprises are emerging nationwide. Consequently, the Food and Drug Administration (FDA) has observed an increase in adverse events associated with these compounded products and is recommending to avoid them when commercial products are available.Recognizing a fake semaglutide injection is imperative to guarantee the receipt of the accurate medication. Furthermore, if one opts for a compounded version, it is essential to ensure the purchase is made from state-licensed pharmacy or outsourcing facilities registered with FDA. This knowledge safeguards against potential health risks and aligns with the principle of making informed decisions regarding personal healthcare.Key Takeaways Understanding semaglutide’s function in regulating blood sugar levels and weight loss Visual Inspection of packaging to identify signs of tampering or counterfeiting Assessing the physical product to ensure the pen and medication look and function correctly Knowing how to assess a pharmacy offering compounded semaglutide injectionUnderstanding Semaglutide’s Many FunctionsPhoto Credit: NPR-Mario Tama/Getty ImagesSemaglutide (Ozempic) is a medication prescribed for the management of type 2 diabetes. Classified as a GLP-1 receptor agonist, its mechanism involves enhancing insulin secretion and reducing glucagon secretion, contributing to the reduction of blood sugar levels. Beyond its primary role in diabetes management, semaglutide offers an additional benefit in weight loss. Branded as its equivalent, Wegovy, the achievement of weight loss is facilitated by mitigating or suppressing appetite through its mimicry of appetite hormones that regulate one’s desire to eat.2Semaglutide is a prescription medication and should only be used under the guidance of a healthcare professional. Patients should follow the instructions provided by their doctor or pharmacist on how to use the medication, including the dosage and frequency of injections.Patients should always purchase their medications from a reputable source, such as a licensed pharmacy. They should also check the packaging and labeling of the medication to ensure that it matches the genuine Ozempic or Wegovy product.In case of any doubts or concerns, patients should consult their healthcare provider or pharmacist for assistance. You can report any suspicious or counterfeit medications to the appropriate regulatory agency, such as the FDA in the United States or the MHRA in the United Kingdom.Visual Inspection of Packaging to Identify Fake Semaglutide When it comes to identifying a fake semaglutide injection, visual inspection of the packaging is a crucial step. Here are some things to look out for:Packaging AnomaliesFigure 1: Authentic versus Fake (Counterfeit) Ozempic (semaglutide) Figure 2: Authentic Wegovy (semaglutide)One of the first things to check is the packaging itself. The packaging of a genuine semaglutide injection should be free from any anomalies such as tears, dents, or scratches. If the packaging appears damaged or tampered with, it could mean that the product is counterfeit.Labeling DiscrepanciesAnother important aspect to check is the labeling on the packaging. An authentic semaglutide injection should have clear and accurate labeling, including the name of the product, the manufacturer, and the dosage. If there are any discrepancies in the labeling, such as misspelled words or incorrect dosages, it is a clear indication that the product is fake.It is important to note: Ozempic is available in pre-filled pens that contain a clear and colorless solution. The pre-filled pens come in three different strengths for single patient use: 2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL. Pen delivers doses in 0.25 mg and 0.5 mg dose increments only1. Wegovy is available in pre-filled pens that contain a clear and colorless solution. The pre-filled pens come in five different strengths for single patient use: 0.25 mg/ 0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/ 0.75 mL, 2.4 mg/ 0.75 mL2.Other things to look out for include the expiration date, batch number, and any other information that should be included on the packaging. If any of this information is missing, incorrect, or appears to be altered, it is a clear indication that the product is counterfeit.Figure 3: Decoding a Ozempic (semaglutide) LabelTake, for instance, Figure 1 of the fake Ozempic carton above. The strength of the pen is missing. The 0.25 mg on the front of the carton is only the dose given with one administration. See below more FDA specific requirements for drug container labels to ensure essential information is provided for safe use. The minimum requirements for a drug container label include3: Drug Name: Clearly display the generic name of the drug and, if applicable, the brand name. Strength: Indicate the strength or concentration of the medication. Dosage Form: Specify the form in which the medication is provided (e.g., tablets, capsules, liquid). Route of Administration: Describe how the medication should be administered (e.g., oral, injection). Manufacturer’s Name and Address: Include the name and address of the drug manufacturer, packer, or distributor. Lot or Batch Number: Display the lot or batch number for traceability in case of recalls or quality issues. Expiration Date: Clearly state the expiration date of the medication. National Drug Code (NDC): Include the NDC, a unique identifier for the medication, facilitating tracking and reporting. Storage Instructions: Provide guidance on how the medication should be stored to maintain its stability. Warning Statements: Include any necessary warnings or cautionary statements regarding potential risks or side effects. Use Instructions: If applicable, provide specific instructions for using the product, especially for devices or products with unique administration requirements.In conclusion, visual inspection of the packaging is a crucial step in identifying a fake semaglutide injection. By checking for packaging anomalies and labeling discrepancies, you can ensure that you are using a genuine product and avoid any potential health risks.Assessing the Physical Product to Identify Fake SemaglutideWhen it comes to identifying a fake semaglutide injection pen, remember that your pharmacist is an invaluable resource. If you have inquiries about a medication acquired online, they are more than willing to assist in verifying the product. Here are some physical characteristics to consider when assessing your purchase:Appearance of the Injection PenReal Ozempic pens have a gray dose button that does not extend as you select a dose. On the other hand, some fake Ozempic pens have a purple dose button that extends outward when setting a dose, making them look just like Semglee, a type of insulin. Patients should also check the dose counter on the pen to ensure that it is accurate and functioning correctly.Example of Semglee Insulin PenWhen examining Wegovy, the authentic Novo Nordisk Wegovy pen exhibits the following distinguishing characteristics:pens are fixed-dose auto-injectors and do not have a push button to administer the medicine pens do not have an option to set a dose and do not extend or increase in length, very similar to Ozempic pensTo learn more details provided by the manufacturer, Novo Nordisk, follow this link.Liquid Consistency and ColorThe liquid inside both the Ozempic and Wegovy pen should be clear and colorless. If the liquid is cloudy or has particles floating in it, it could be a sign of a counterfeit product. Patients should also check the expiration date on the pen to ensure that it has not expired.It is important to note that while these physical characteristics can be helpful in identifying a fake semaglutide pen, they are not foolproof. Patients should always purchase their medication from a reputable source and report any suspicious products to the FDA.Verification Processes to Identify Fake SemaglutideChecking Authenticity with ManufacturerOne of the most reliable ways to verify the authenticity of a semaglutide injection is to check with the manufacturer. Novo Nordisk is the only authorized manufacturer of this medication. The company has introduced several measures to prevent the distribution of counterfeit products.One such measure is the use of the drug national drug code (NDC) on every pack of Ozempic. This code can be used to verify the authenticity of the product by visiting the manufacturer’s website or calling their customer service hotline. It can also be verified on the FDA and national library of medicine (NLM) websites.Verifying Compounded ProductsAccording to the FDA, patients are advised NOT to use a compounded drug when an approved alternative is commercially available. In specific medical scenarios, certain conditions may necessitate the use of compounded medications. However, there is a noticeable misuse or overuse of this pharmaceutical service and there needs to be more clarity for the general public.Compounded versions of drugs are NOT reviewed for safety, effectiveness, or quality by the agency. The FDA permits the compounding of medications when they are added to the “drug shortage list.” Even when a medication is listed, there are restrictions on how it should be compounded. To qualify for compounding under Section 503A of the FD&C Act, a medication must satisfy the following criteria:comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding; are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or Appear on the 503A Bulks List published by the FDA if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.Please note: If a company claims to be an outsourcing facility they compound under section 503B of the FD&C act and to verify they are registered with the FDA click here.Why is all this so concerning? Recent reports have shown an uptick in adverse events following the use of compounded semaglutide. Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as as FDA-approved semaglutide products and may be the salt formulations. These specific salts have NOT been shown to be safe and effective. Another report from the FDA , found that companies were distributing multi-dose vials of medication leading to dosing errors at home and even patients being prescribed the wrong dose. Some patients received 10x the recommended dose of semaglutide. Safety and Quality of Online SemaglutideRecently a group of researchers decided to investigate the safety and quality of semaglutide sold online without a prescription4. Here’s what they did and discovered:Search and Purchase:They searched Google and Bing for websites selling semaglutide without a prescription. They identified 134 sites that appeared to be illegal pharmacies, which made up 42.27% of the 317 online pharmacies found in their search. From these, they selected six vendors to purchase semaglutide products, either in prefilled pens or vials.Testing the Products:The researchers received only three of the six products they ordered. The other three vendors turned out to be scams, asking for additional payments to “clear customs.” The products were inspected and tested for quality, sterility, and the actual content of semaglutide using advanced methods like liquid chromatography-mass spectrometry (LC-MS).Results:All received products had significant issues. They showed clear discrepancies in labeling and packaging, suggesting they were likely unregistered or unlicensed. One product had high levels of endotoxins, indicating possible contamination. The actual semaglutide content was far lower than advertised, ranging from 7% to 14% purity compared to the claimed 99%. The measured amount of semaglutide in the products was up to 39% higher than what was labeled, posing a risk of overdose.Verifying Online PharmaciesIf it is absolutely necessary to acquire a compounded version of a medication online, it is advisable to utilize BeSafeRx, an online campaign that educates users on how to safely purchase prescription medications over the internet5. Other ways to verify an online pharmacy are through the National Association of Boards of Pharmacy and LegitScript. Another way to determine an online pharmacy has been verified by LegitScript is looking for the logo below with the seal, I still advise to check the website verification tool for confirmation. I have provided the direct links to verify the online pharmacies on both platforms. Stay informed and stay safe!Also, other tips to consider provided by the Alliance of Pharmacy Compounding include: Do NOT purchase a compounded medication from a pharmacy: If you do not have a legitimate prescription for a compounded medication from a licensed prescriber; and You cannot verify that the seller is a licensed U.S. pharmacy. Questions to ask about the compounding pharmacy and also to verify online through your state board of pharmacy website: Name of the compounding pharmacy? Where it’s located? Is it licensed to dispense in or ship to your state? One additional step, I personally as a pharmacist would take, is asking the compounding pharmacist to show you a Certificate of Analysis. This is a thorough scientific report that will allow you to verify the identity of the medication being dispensed to you.Pharmaceutical Regulations and StandardsPharmaceutical regulations and standards are in place to ensure that medications are safe and effective. The United States Food and Drug Administration (FDA) is responsible for regulating medications in the United States. The FDA has strict regulations and standards in place to ensure the safety and efficacy of medications, including semaglutide.The FDA recommends that patients only purchase medications from licensed pharmacies or reputable online retailers. Patients should also be wary of purchasing medications from unlicensed sources, as these products may be counterfeit or contaminated.In addition to the FDA, other regulatory bodies, such as the European Medicines Agency (EMA), have similar regulations and standards in place to ensure the safety and efficacy of medications. Patients should always check the regulatory status of a medication before purchasing it.Overall, patients can take several steps to verify the authenticity of semaglutide injections. Checking with the manufacturer and verifying the regulatory status of the medication are two reliable ways to ensure that patients are receiving safe and effective medications.If you know of someone or a company unlawfully selling medical products you can report to the FDA at this LINK.If you have experienced an adverse effect (an undesirable and often harmful reaction resulting from the use of a medication, treatment, or intervention) you can report it to the FDA at this LINK.Report suspected criminal or counterfeit activity at this LINK.Directions for Use: Identifying Fake SemaglutideIn conclusion, as a dedicated pharmacist, I am deeply concerned about the risks associated with counterfeit and compounded semaglutide injections. This highlights the critical need for vigilance and awareness when purchasing medications from a non-licensed state pharmacy. By staying informed and leveraging the expertise of pharmacists, we can better navigate medication authenticity and safeguard public health. As we work toward a healthier society, let’s remain committed to transparency, education, and the protection against unethical practices.SourcesSemaglutide (Ozempic). Prescribing Information. Novo Nordisk Inc. September 2023. Accessed December 29, 2023. https://www.novo-pi.com/ozempic.pdf. ↩︎Semaglutide (Wegovy). Prescribing Information. Novo Nordisk Inc. July 2023. Accessed December 29, 2023. https://www.novo-pi.com/wegovy.pdf. ↩︎U.S. Food and Drug Administration. Carton and Container Labeling Resources. FDA. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/carton-and-container-labeling-resources. Updated August 8, 2022. Accessed December 22, 2023. ↩︎Ashraf, A. R., Mackey, T. K., Schmidt, J., Kulcsár, G., Vida, R. G., Li, J., & Fittler, A. (2024). Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases. JAMA Network Open, 7(8), e2428280. ↩︎U.S. Food and Drug Administration. Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss. Updated December 21, 2023. Accessed December 28, 2023. ↩︎Refill Your Knowledge HERE. “Your health is your most valuable possession. Take care of it, nurture it, and make informed choices for a well-rounded life.” SubscribeBuilt with ConvertKit Share this:FacebookLinkedInPinterestEmail Decoding Labels GLP-1 Medications Pharmacy Insights Semaglutide fakemedicationsfakeozempicfakesemaglutideweightlossmedications
GLP-1 Medications The Best Nonalcoholic Mocktail Recipe for Semaglutide Users June 26, 2024July 10, 2024 Discover the best nonalcoholic mocktail recipe for semaglutide users! Refreshing, muscle-boosting, and anti-nausea—perfect for building lean muscle! Share this:FacebookLinkedInPinterestEmail Read More
Adherence Tips How to Find Time for Exercise in Your Busy Schedule September 23, 2024September 25, 2024 Discover how to find time for exercise in a busy schedule. Incorporate 30 minutes of cardio and 15 minutes of strength training into any daily routine. Share this:FacebookLinkedInPinterestEmail Read More
GLP-1 Medications Dietary Recommendations While on GLP-1 Medications December 20, 2024December 20, 2024 Discover key dietary recommendations while on GLP-1 medications. This guide will help you achieve optimal results with GLP-1 medications. Share this:FacebookLinkedInPinterestEmail Read More