The medication semaglutide gained popularity during the last year for the treatment of weight loss. The increased demand for the medication led to many websites cashing in on the opportunity and creating counterfeit products and selling them without valid registration and license, risking the patient's life. As the cost of the drug was also high, it led people to turn to online websites to obtain them. Ozempic and Wegovy are the two brand names of semaglutide that were in demand for type 2 diabetes and, most importantly, obesity.
Semaglutide belongs to a class called incretin mimetics. Semaglutide is used in type 2 diabetes to control blood sugar levels. It is also used in diabetic individuals with heart and blood vessel disease to reduce the risk of heart attack and stroke. Semaglutide injection, if incorporated with a low-calorie, low-fat diet, and exercise, can help in reducing weight in obese patients.
The mechanism by which it reduces blood sugar levels is that it stimulates the pancreas to release insulin into the bloodstream, which then utilizes the insulin from the blood for energy and lowers blood sugar levels. Another mechanism of semaglutide injection is that it helps reduce weight by slowing down food movement in the stomach, thereby leading to loss of appetite.
Implementation of lifestyle modifications, i.e., reducing weight, regular exercise, and monitoring of blood sugar levels, along with the use of semaglutide injections, helps in managing diabetes and reduces the risk of heart attack and stroke. Apart from these, it can also be used to reduce diabetic complications like nerve damage, vision loss, or gum disease.
Side effects of semaglutide injection are nausea, vomiting, diarrhea, abdominal pain, constipation, heartburn, and burping.
Serious side effects are:
pain with or without vomiting that begins in the upper left or middle of the stomach but may spread to the back
rashes, itching; swelling of the eyes, face, mouth, tongue, or throat
dyspnea or dysphagia
decreased urination; or swelling of legs, ankles, or feet
vision changes
fainting or dizziness
yellowing of skin or eyes; fever; or clay-colored stools
rapid heartbeat
light-headedness, sweating, confusion or drowsiness, headache, slurred speech, shakiness, anxiety or irritability or mood changes, hunger, weakness, or feeling jittery
As the demand for semaglutide increased, the FDA, WHO, and European agencies warned of several adulterated products that were being sold illegally without a prescription. To identify the fake products, a study was conducted from August 2023 to March 2024 and published in JAMA Network Open on August 2, 2024. It was initiated by searching websites that sold this medication without a prescription. The aim was to carry out the following:
Visually comparing the ordered product with the genuine ozempic product according to the International Pharmaceutical Federation’s (FIP) checklist
Quality inspection, including sterility and microbiological contamination according to European and US Pharmacopoeia guidelines.
Active ingredient quantification using liquid chromatography-mass spectrometry (LC-MS).
For the study, six test purchases from vendors who were offering the injection were included. The test purchases were made through email and WhatsApp. They were labeled as not recommended by the National Association of Boards of Pharmacy. Among them, three websites offered prefilled 0.25-mg per dose semaglutide injection pens, and three sold vials of lyophilized semaglutide to be reconstituted into a solution for injection (1-3 mg). Each vendor's website page included products for obesity and weight loss. The price ranged from US $113 to $360 for the smallest dose and quantity.
The study reported that after the purchase, only 3 were delivered, and the remaining three of them did not deliver and were engaged in fraudulent activities and demanded extra money. After receiving, the inspection revealed that:
Compared to the original ozempic score of 22, the test purchases scored only 8 to 9 points in the FIP checklist. (Discrepancies: unclear labeling, registration, and invalid license)
Quality testing revealed the presence of endotoxins in one of the samples but did not show any growth of microorganisms.
Quantification of the active ingredient revealed that the semaglutide content was more than the amount mentioned on the label (29% mentioned on the label, but the sample had 39%).
The purity levels when tested by liquid chromatography-mass spectrometry (LC-MS) were found to be 7–14%, whereas it was advertised as 99% purity.
According to an article, the FDA has issued a warning letter to the owners of www.ozempen.com for selling counterfeit medications.
Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, the FDA requests that www.ozempen.com cease offering unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.Food and Drug Administration (FDA)
Previously, the FDA also sent letters to two online vendors, Helix Chemical Supply and US Chem Labs, after it was found that they supplied unapproved, misbranded, and counterfeit medications of semaglutide.
The study published in JAMA Network Open concluded that the semaglutide products were sold online illegally without valid prescriptions. The study revealed that about 42% of pharmacies were involved in illegal operations. The product quality was also compromised, and vendors were selling counterfeit products, which compromised the health and well-being of many people. It was also found that a higher content of semaglutide was found, which can lead to adverse effects.
REFERENCES:
1. Semaglutide injection: MedlinePlus drug information. (n.d.). https://medlineplus.gov/druginfo/meds/a618008.html
2. 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. https://doi.org/10.1001/jamanetworkopen.2024.28280
3. FDA tells another online retailer to stop selling unapproved popular weight-loss drugs. (n.d.). RAPS. https://www.raps.org/news-and-articles/news-articles/2024/7/fda-tells-another-online-retailer-to-stop-selling
4. https://www.reuters.com/business/healthcare-pharmaceuticals/fda-warns-online-vendors-selling-misbranded-weight-loss-diabetes-drugs-2024-02-13/