Mounjaro prescribed to pregnant women in 325 cases despite warnings
核心洞察
Drug Utilization Review data show 325 Mounjaro prescriptions for pregnant women in South Korea from August 2025 through July 2026, despite labeling that says the drug must not be used in pregnancy.
The same data show 110 prescriptions to children under 13 and 36,135 prescriptions to patients aged 65 and older over the same period.
The Ministry of Food and Drug Safety (搜索) reported 1,261 adverse events for Mounjaro to the Korea Institute of Drug Safety & Risk Management (搜索) over 11 months, with 72.6% occurring from January to June 2026.
Mounjaro (tirzepatide) was prescribed 325 times to pregnant women in South Korea during the year from its August 2025 launch through July 2026, according to Drug Utilization Review service data submitted to the Health Insurance Review & Assessment Service (搜索) by Rep. Baek Jong-heon of the National Assembly Health and Welfare Committee. The Ministry of Food and Drug Safety (搜索) approved labeling states the drug must not be used during pregnancy and instructs patients to discontinue treatment if they are planning to become pregnant or become pregnant. Whether the prescriptions led to actual administration has not been confirmed.
The same data set recorded 110 prescriptions for children younger than 13, a population in which Mounjaro's safety and efficacy have not been established, and 36,135 prescriptions for patients aged 65 and older, a group showing a month-by-month upward trend. MFDS labeling notes that greater sensitivity in some older patients cannot be ruled out from clinical trials and that treatment experience in patients aged 85 and older is very limited.
Adverse events reported to the Korea Institute of Drug Safety & Risk Management (搜索) totaled 1,261 over the 11 months from August 2025 through June 2026, rising from 35 in September 2025 to 215 in February 2026; the 916 reports from January through June 2026 accounted for 72.6% of the total. The MFDS notes that adverse-event reports do not necessarily correspond to side effects caused by the drug. The agency is pursuing designation of Mounjaro and Wegovy as medicines at risk of misuse and abuse, which would add warning statements to product packaging.