The World Health Organization (WHO) has issued a drug alert for counterfeit semaglutide, a type of drug used in some countries to treat type 2 diabetes and obesity.
The alert concerns 3 counterfeit batches of a semaglutide drug class product (specific brand Ozempic) detected in Brazil in October 2023, the United Kingdom of Great Britain and Northern Ireland in October 2023, and the United States of America in December 2023. The Global Surveillance System and monitoring (GSMS) of the WHO from 2022 records an increased number of reports of counterfeit semaglutide products in all geographical areas. This is the first official announcement issued by the WHO after confirming some reports.
“WHO advises health professionals, regulatory authorities and the public to be aware of these counterfeit drug batches,” said Dr. Yukiko Nakatani, WHO Deputy Director-General for Access to Medicines and Health Products. “We urge the parties involved to stop using the suspected drugs and report it to the relevant authorities.”
Stock shortages and increased counterfeiting
Semaglutide, including a specific brand-name product that was counterfeit, is prescribed to people with type 2 diabetes to lower blood sugar. Semaglutide also reduces the risk of cardiovascular events. Most semaglutide preparations must be injected under the skin once a week, but they are also available as tablets taken daily by mouth. In addition to lowering blood sugar, these drugs have been shown to suppress appetite, which is why they are increasingly being prescribed for weight loss in some countries.
WHO observes increased demand for these drugs as well as reports of counterfeiting. These counterfeit products could have harmful effects on human health; if the products do not contain the necessary raw materials, counterfeit drugs can lead to health complications resulting from uncontrolled blood glucose levels or weight. In other cases, the injection device may contain another undeclared active substance, such as insulin, leading to an unpredictable range of health risks or complications.
Semaglutides are not part of the WHO-recommended diabetes treatment because of their current high cost. The cost barrier makes these products unsuitable for a public health approach that aims to ensure the widest possible access to medicines at the population level and to strike a balance between the best established level of care and what is possible on a large scale in resource-limited settings. There are also more affordable diabetes treatments with similar effects to semaglutide on blood sugar and cardiovascular risk.
WHO is currently working on a rapid recommendation on the possible use of GLP-1 RAs, including semaglutide, for the 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 semaglutide, for a class of drugs used to treat diabetes to lower blood sugar and promote weight loss.
Individual action
To protect themselves from counterfeit drugs and their harmful effects, patients using these products can take steps such as buying prescription drugs from licensed doctors and avoiding buying drugs from unknown or unverified sources, such as those found online .
People should always check packaging and expiry dates when buying medicines and use products as prescribed. For injectable semaglutide, patients should ensure that it is refrigerated. All reports of counterfeit medicines can be sent to WHO at rapidalert@who.int.