“Wegovy” manufacturer criticized: is the weight loss syringe harmful?

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Lose weight, keep it off, banish hunger for chips and sweets – all this is promised by the “Wegovy” weight-loss syringe. The drug from the Danish manufacturer Novo Nordisk has been on the German market for around two weeks. Now, however, a report by the news agency “Reuters” raises serious allegations against the pharmaceutical company and its manufacturers. Accordingly, the company Catalent, in which the agent was processed, is said not to have adhered to all the necessary hygiene requirements.

Allegations against “Wegovy” manufacturers

The “Reuters” report accuses the “Wegovy” pen of Catalent of two points:

The factory that fills the self-injection pens for the booming weight-loss drug Wegovy has repeatedly violated US sterile safety regulations in recent years. In addition, the staff failed to carry out the necessary quality checks.

This was shown by documents available to the news agency. The violations were identified by US Food and Drug Administration inspectors who visited the Brussels plant in October 2021 and August 2022. It is “the most serious form of violations,” it said. For example, there are said to have been problems with the air filter systems that are necessary to maintain sterile operating conditions. And: “The violations also included the failure to regularly check that the equipment was not contaminated with microbes.”

Between the two inspections, Catalent shut down the facility twice to address sanitation issues. Only then did the FDA give the green light for further production. For this reason, the delivery of “Wegovy” is said to have been delayed in the course of 2022. “Both companies and the FDA declined to comment on the specific inspection findings,” Reuters continues.

However, it is not clear from the reports which drugs were manufactured via the lines examined. It is therefore not clear whether and how many batches of the “Wegovy” agent are affected. Since, according to the manufacturer, the product has a shelf life of two or three years, depending on the dosage, it would theoretically be possible for batches that are now being sold to be affected.

Experts emphasize: contamination could have serious consequences

“Based on the findings of the FDA, I would have concerns about the sterility of the products manufactured at this site,” said Susan Bain, assistant professor of regulatory and quality sciences at the University of Southern California and former FDA inspector “Reuters “. In total, the news agency interviewed a dozen experts. They had emphasized “that the consequences of a sterility error when filling medicinal products could be serious.”

For example, an injection with microbial contaminants could cause serious infections and, in the worst case, even lead to death.