Botox Scandal Reminiscent of Invossa... "Ingredients Changed but No Safety Issues," Claims

Lee Eui-kyung, Commissioner of the Ministry of Food and Drug Safety, is announcing safety management measures for patients treated with the osteoarthritis gene therapy drug 'Invossa-K Injection' (Invossa) at the Seoul Regional Ministry of Food and Drug Safety office in Yangcheon-gu, Seoul, in June last year. Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety's (MFDS) announcement of the cancellation of the product approval for Medytox's botulinum toxin (Botox) Meditoxin recalls the ongoing controversy surrounding Kolon Life Science's Invossa-K injection (hereafter Invossa) that erupted last year. It was later revealed that the ingredients submitted during the regulatory approval process differed from those actually produced and sold. While Invossa has faced large-scale lawsuits primarily from some patients who received the treatment, there have been no collective lawsuits regarding Meditoxin so far.

In the case of Invossa, the change in ingredients was revealed last year, leading to the suspension of ongoing clinical trials in the United States and the cancellation of product approval in South Korea. Company executives were even detained over whether they had prior knowledge of the inclusion of components with potential tumorigenic risks. Kolon is currently contesting the cancellation through litigation, arguing that the technology available at the time of development could not have detected the cancer-causing potential. Meditoxin has acknowledged that the raw materials of products produced between 2012 and 2015 were changed. However, the company maintains that this was a deviation carried out by some staff members during the process to meet sales targets, and not a company-wide decision.

Both companies claim there are no safety issues with Invossa or Meditoxin. Invossa recently received notification from the U.S. Food and Drug Administration (FDA) to resume clinical trials, and Meditoxin has been sold since its launch in 2006 without any reported adverse events. The MFDS also emphasizes that the issue lies not with safety but with discrepancies between the originally submitted documents and the actual product.

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