U.S. Eli Lilly's diabetes and obesity drug "Mounjaro (ingredient tirzepatide)" was found to have 35 adverse events reported in Korea in the first month after its launch.
This reportedly includes "serious adverse events," drawing attention. The Regulation on Safety of Drugs, etc., defines serious adverse events as cases that require treatment when medically important situations occur, such as death or life-threatening events, hospitalization or prolonged hospitalization, and persistent or significant disability or functional decline.
Mounjaro landed in Korea in Aug. On the 10th, lawmaker Seo Mihwa of the Democratic Party of Korea on the National Assembly Health and Welfare Committee disclosed data submitted by the Korea Institute of Drug Satety & Risk Management under the Ministery of Food and Drug Safety showing that 35 adverse events were reported through Sept. Two serious adverse events, including diarrhea and hypoglycemic shock, were also included.
By gender, there were 15 cases in women and 4 in men. The remaining 16 cases did not report the patient's gender.
By age, seven cases were reported among those 19 and older but under 65. The ages of the remaining 28 patients were not reported.
Seo said, "Demand for weight-loss drugs is rising, and concerns about how clinicians are prescribing them continue to be raised," adding, "The Ministery of Food and Drug Safety should step up crackdowns on improper advertising through its online cyber task force, and the Korea Institute of Drug Satety & Risk Management should closely analyze adverse event cases."
However, adverse drug reactions reported to the Korea Institute of Drug Satety & Risk Management include cases where a causal relationship with the drug has not been established. That means the adverse events in these materials cannot be confirmed to have occurred because of Mounjaro.
Eli Lilly Korea said, "Since Mounjaro was launched in Korea, we have faithfully reported safety information that occurred in real-world clinical settings to the regulatory authorities in accordance with relevant regulations," and added, "We will continue to work with the government and relevant academic societies to ensure that Mounjaro is used safely and appropriately in Korea."