Osteoarthritis treatment Invossa-K, recently suspended due to safety risk, was supplied to Severance Hospital the most among the nation’s five largest hospitals, a lawmaker said.
A total of 177 Invossa goods were distributed to tertiary general hospitals. Among them, 28 went to Severance Hospital, 16 to Seoul National University Hospital, and 10 to Samsung Medical Center.
Rep. Oh Jae-sae of the ruling Democratic Party released analyzed data from the Ministry of Food and Drug Safety.
According to Rep. Oh, 441 hospitals and clinics, including two for exports, bought Invossa as of March 31. Among the 441, 22 were tertiary hospitals, 84 were general hospitals, 234 were hospitals, and 99 were clinics.
A total of 3,777 Invossa injections were distributed to the 441 hospitals – 117 to tertiary hospitals, 2,379 to general hospitals, 684 to hospitals, 367 to clinics, and 70 to exporters.
Invossa is a treatment for knee osteoarthritis in patients with moderate symptoms who have no progress with medication or physical therapy. However, the ministry suspended the sales and distribution of the medicine on March 31, as the company revealed that one of the two main cell ingredients had been mislabeled.
The ministry gave the go-ahead for Invossa after confirming that the main ingredient of the second fluid of the drug was cartilage cells. However, a recent cell test showed that the cells were not cartilage-derived but kidney-derived cells, also known as GP2-293 cells.
GP2-293 cells are abnormal cells with the possibility to cause cancer and experts raised safety concerns over Invossa.
The Korea Institute of Drug Safety and Risk Management (KIDS) received 102 cases of adverse drug reactions in Invossa and three of them were gastric cancer, goiter, and benign gastric neoplasm.
However, the ministry said the three side effects did not have a causal relationship with Invossa. At the time of approving, the ministry confirmed that there was no possibility of tumor development in the drug through a tumorigenicity test, on the assumption that Invossa’s ingredients were cartilage cells.
The ministry also said it would monitor patients treated with Invossa to learn how the injection affects the human body and conducting long-term follow-ups, and analyze the patients’ medical history via KIDS to identify adverse reactions.
Rep. Oh said, “Fears over Invossa’s risk of developing cancer are growing. The government should make all-out efforts to find facts about Invossa and set up measures to prevent a similar mishap.”