On December 20, the Paris Court of Appeals in France upheld a verdict against the pharmaceutical giant Sanofi for "serious fraud" and "involuntary manslaughter," imposing a fine totaling over €430 million, approximately 3.36 billion yuan. This decision comes after one of the company's diabetes medications was misused as a weight-loss drug, resulting in at least 500 deaths. Sanofi has announced plans to appeal to the Supreme Court.
According to Reuters, the drug in question is Mediator. The French court found Sanofi guilty of fraud and other charges, noting that the company was aware of the potential harm of the drug when it was marketed.
Previously, Sanofi argued that the company was only aware of the dangers posed to consumers by Mediator in 2009 and had never claimed it was a weight-loss drug. Sanofi China has not responded to these allegations.
The main ingredient in Mediator is benfluorex, used not only as a primary treatment for obese patients with diabetes but also considered an effective appetite suppressant for treating obesity in non-diabetic patients. The drug was introduced to the market in 1976 and withdrawn in 2009 after 33 years.
Misuse of diabetes medication for weight loss has been an ongoing issue. In the vast market of diabetes treatment, there are many drugs, including classic ones like metformin and newer ones like acarbose, DPP-4 inhibitors, SGLT2 inhibitors, and the increasingly popular GLP-1 class drugs. Metformin, SGLT-2 inhibitors, and GLP-1 receptor agonists are known for both reducing blood sugar and aiding in weight loss. Consequently, drugs like metformin and empagliflozin have been used for weight loss purposes.
In recent years, star diabetes and weight loss products like semaglutide have exploded in popularity. It's not uncommon for non-diabetic obese patients and even those not diagnosed as overweight to use these diabetes medications for weight loss. In the latter half of this year, countries like the UK, the USA, and Belgium have issued statements restricting the use of semaglutide to prevent drug misuse.
Semaglutide is a GLP-1 receptor agonist, originally used to treat type 2 diabetes and later developed for treating obesity due to its low adverse reactions and high weight loss efficacy. The FDA approved liraglutide and semaglutide for weight loss in 2014 and 2021, respectively. Due to its better results and once-weekly administration, the latter quickly gained popularity.
However, it's important to note that drugs like semaglutide have strict indications for weight loss. In the US, it's approved for obese adults with a BMI ≥30 kg/m2 or overweight adults with at least one weight-related condition (such as hypertension, type 2 diabetes, or dyslipidemia) with a BMI ≥27 kg/m2. Additionally, semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in those with Multiple Endocrine Neoplasia syndrome type 2. This means the drug is not suitable for everyone and has specific contraindications.
Moreover, approval for weight loss in the US doesn't mean it's directly applicable to the Chinese population. In China, semaglutide is only approved for type 2 diabetes, and its weight loss indication is still under application. In other words, its efficacy and safety for weight loss in the Chinese population have not yet been approved by regulators. Using the drug for weight loss is currently considered off-label.
As these medications are used on a large scale in the real world, some safety issues have emerged. In October, the FDA issued a warning about semaglutide, stating it could cause two adverse reactions: hypoglycemia when interacting with other drugs and gastrointestinal obstruction.
In the evolving field of GLP-1, enhancing safety and reducing side effects and adverse reactions are considered directions for differentiation and optimization by newcomers, as well as challenges in research and development.
From a medication perspective, it's crucial that drugs like liraglutide and semaglutide, which are prescription medications, are used under the guidance of a professional doctor and not misused.
Ji Lianmei, former director of the pharmacy at Beijing United Family Rehabilitation Hospital, told Interface News that consumers often overlook the safety of using semaglutide for weight loss. For instance, before using the drug, it's necessary to assess whether the user has related endocrine diseases, especially since those with a history of thyroid C-cell tumors are contraindicated for semaglutide use. Additionally, patients with severe gastrointestinal reactions may also have diseases like pancreatitis or gallstones, so regular follow-up visits are needed during medication use to detect any related symptoms promptly.
