GLP-1 counterfeit drugs rampant, Lilly will file another lawsuit

October 26, 2024  Source: drugdu 44

Eli Lilly has taken further legal action against the continuous emergence of counterfeit products of Tilpotide.

Recently, Eli Lilly has filed a lawsuit against three suppliers of counterfeit tiltrotide products that have not been approved by the FDA. The company is seeking a court order to stop the sale of these counterfeit tiltrotide products and demand economic compensation from these suppliers.
The rampant use of counterfeit drugs

The soaring demand for GLP-1 has not only made Novo Nordisk and Eli Lilly one of the most valuable companies in Europe, but also led to long-term supply shortages around the world. In order to get a share of the pie, some illegal merchants have engaged in rampant counterfeiting and forgery of the products of the two companies. These unregulated counterfeit drugs pose significant risks to the health of patients and may even endanger their lives.
In December last year, the FDA issued a notice on its official website, seizing thousands of counterfeit Meigelutide injections. The FDA advised wholesalers and retail pharmacies not to distribute, use, or sell counterfeit products with the production batch number NAR0074.
In batch NAR0074, real semaglutide was used, but its injection needle was fake and its sterility is unknown.
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Fake drugs pose a greater security risk, as some illegal merchants illegally sell them by forging drug production batch numbers.
A large amount of counterfeit drugs were mixed into the production number MP5B060 of semaglutide, and the active ingredient of these counterfeit drugs is insulin, which has been re labeled and packaged as semaglutide. According to the investigation, the counterfeit drugs mixed into batch MP5B060 have been circulating in at least 11 countries including the UK, Mexico, Bangladesh, Iraq, and Lebanon.
Taking such counterfeit drugs can pose significant safety risks to patients. Injecting excessive insulin can lead to low blood sugar or glucose levels, causing hypoglycemia. In severe cases, it may develop into loss of consciousness or seizures.
In July 2023, the World Health Organization issued a warning against the mixing of counterfeit drugs in batch MP5B060, and some countries/regions have even banned the use of products with this production number.
The risks of compound drugs

In addition, unapproved combination drugs also pose significant health risks.
Compound drugs are a practice adopted by the FDA to allow licensed pharmacies to self formulate formulas, dosages, and administration methods in order to address the shortage of marketed drugs and the clinical needs of specific individual patients.
However, in some pharmacies, the active ingredients in compound drugs are too few, too many, or completely absent, and some even contain incorrect or harmful ingredients.
These compound drugs have caused some patients to misuse their medication. Some patients with mild symptoms may experience gastrointestinal reactions, fainting, dehydration, headaches, gallstones, and acute pancreatitis, while severe cases may even require hospitalization.
According to statistics, on August 31st of this year, the FDA stated that it had received 346 reports of adverse events related to compound semaglutide and 136 reports of adverse events related to compound tilpotide, a significant portion of which were related to the use of incorrect drug doses.
In March 2024, Eli Lilly stated that it would not provide the active ingredient of Mounjaro and Zepbound, tilboptide, to any compound pharmacies. In May 2024, the Australian government announced a complete ban on compound tilpotide. Recently, Novo Nordisk has also requested the FDA to ban the combination therapy of semaglutide.

By editor
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