Amsterdam: In April, the FDA sounded a familiar warning to consumers of an ongoing problem in the United States—the sale of unauthorized compounded and counterfeit versions of Novo Nordisk’s and Eli Lilly’s popular diabetes and weight loss drugs.
Now, five months later, regulators in Europe are doing the same in response to a “sharp rise” in illegal medicines advertised as Lilly’s tirzepatide or Novo’s semaglutide or liraglutide.
The European Medicines Agency and the Heads of Medicines Agency (HMA) issued the alert this week to consumers for products that are largely sold on fraudulent websites and through social media promotions, which do not meet the standards established by the regulators for safety, quality and efficacy.
The regulators said that authorities have uncovered hundreds of fraudulent Facebook profiles, websites and e-commerce listings, with many hosted outside of Europe. In collaboration with enforcement officers and international partners, officials have blocked some websites and ordered product withdrawals.
The issue with the online sale of counterfeit drugs has been ongoing and growing since the metabolism-regulating treatments were identified in trials as being able to help users lose weight.
In 2023, for example, AI-powered cybersecurity firm BrandShield—which helps companies identify unauthorized sellers of their products in all industries—discovered more than 250 websites selling illegitimate versions of Novo’s and Lilly’s weight loss drugs, versus 34 in the previous year.
In 2023, three people in the U.S. were hospitalized with dangerously low levels of blood sugar attributed to the use of counterfeit versions of Novo’s Ozempic.
“They may not contain the claimed active substance at all and may contain harmful levels of other substances,” the EMA wrote in its warning. “People who use these products are therefore at a very high risk of treatment failure, unexpected and serious health problems and dangerous interactions with other medicines.”
This week, the EMA reminded consumers that prescription medicines should be taken under the supervision of a healthcare professional and that their online sale is barred in many member states.
To help the public identify legitimate online medicine retailers, the EU uses a logo that appears on the websites of all registered online pharmacies and retailers. Clicking on the logo takes buyers to a national register of authorized retailers, the EMA said.
FDA restricts imports of API for GLP-1 drugs
In another move designed to limit the manufacture of illegitimate diabetes and weight loss drugs, the FDA has established a “green list” import alert to help halt the import of GLP-1 active pharmaceutical ingredients (APIs) from unverified foreign sources, the agency announced on Friday.
The move is designed, the FDA said, to safeguard consumers from unsafe GLP-1s and to secure the supply chain. It also will help limit the production of unregulated compounded versions of Eli Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy, which are not endorsed by the FDA.
The agency has identified issues with compounded versions of the treatments, including dosing errors, use of unapproved salt forms and adverse events—some requiring hospitalization—the FDA added.
