HQ Team
June 21, 2024: The World Health Organization has issued a medical product alert on falsified semaglutides, an active ingredient in Ozempic, a diabetic drug made by Novo Nordisk and weight-loss medication Wegovy.
The alert three falsified batches of semaglutide detected in the UK, Northern Ireland, and Brazil in October last year and in the US in December 2023, according to a WHO statement.
“WHO Global Surveillance and Monitoring System has been observing increased reports on falsified semaglutide products in all geographical regions since 2022.
“This is the first official notice issued by WHO after confirmation of some of the reports.”
Falsified medical products may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient. They are also found to commonly contain corn starch, potato starch or chalk.
Blockbuster growth
Falsified medical products that deliberately or fraudulently misrepresent their identity, composition or source, according to the WHO.
Blockbuster growth in weight-loss drugs was the main driver of a 13.5% increase in spending on prescription medications in the U.S. in 2023, according to a report from the American Society of Health-System Pharmacists, National Trends in Prescription Drug Expenditures and Projections for 2024.
Expenditures for semaglutide doubled last year, making it the new top-selling drug in the U.S., replacing adalimumab, which treats autoimmune diseases like rheumatoid arthritis and Crohn’s disease.
Spending on the diabetes drug tizepatide, sold under the brand name Zepbound and Mounjaro by Eli Lilly and Co, grew by 373% even though its approval for weight loss came late in 2023.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating.
Feeling of fullness
One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.
The semaglutides, including Ozempic, are prescribed to people with type 2 diabetes to lower their blood sugar levels. Semaglutides also reduce the risk of cardiovascular events.
Most semaglutide products must be injected under the skin every week and are also available as tablets taken by mouth daily. These medicines are shown to suppress appetite and lower blood sugar levels and are increasingly prescribed for weight loss in some countries.
The WHO stated it had observed an increased demand for these medicines as well as reports on falsification.
“These falsified products could have harmful effects to people’s health; if the products don’t have the necessary raw components, falsified medicines can lead to health complications resulting from unmanaged blood glucose levels or weight.
High cost
“In other cases, another undeclared active ingredient may be contained in the injection device, e.g. insulin, leading to an unpredictable range of health risks or complications.”
Semaglutides are not part of WHO-recommended treatments for diabetes management due to their current high cost. There are more affordable treatments available for diabetes, with similar effects to those of semaglutides on blood sugar and cardiovascular risk, according to the WHO.
The WHO is currently working on a rapid advice guideline on possible use of GLP-1 RAs, including semaglutides, for treatment of obesity in adults and as part of a more comprehensive model of care.
The term GLP-1 RAs stands for glucagon-like peptide-1 receptor agonists, which include semaglutides, for a class of medicines used for diabetes treatment to lower blood sugar and support weight loss.
