Korea's only etomidate-based general anesthetic may soon disappear from the medical scene, with the importer B. Braun Korea and physicians blaming excessive regulation by the Ministry of Food and Drug Safety (MFDS).

According to the latest drug supply interruption and shortage report released by the MFDS, Etomidate-lipuro Injection, an etomidate-based general anesthetic, will be discontinued on Nov. 1.

On Monday, B. Braun Korea announced its plan to halt product supply, with the last shipment scheduled for Oct. 31.

The company said the drug would be designated as a psychotropic substance, ending its sales contract with the current domestic distributor this year. It added that it is uncertain whether the contract will be renewed or if a new distributor will be secured, and the timing of future imports and resumed supply remains undecided.

Etomidate-lipuro Injection is the only etomidate-based injection available in Korea, with no generic alternatives. B. Braun Korea noted that other medications such as propofol, ketamine, and midazolam offer similar efficacy and effectiveness.

The MFDS has recently tightened regulations surrounding etomidate. In February, it issued a legislative notice to amend the Enforcement Decree of the Act on the Control of Narcotic Drugs to classify etomidate as a narcotic drug. On April 8, the MFDS officially designated etomidate-containing preparations as “drugs of misuse and abuse” through an amendment to the relevant regulations.

In March, the government conducted a joint inspection targeting the illegal distribution of drugs containing steroids, etomidate, and ephedrine across 17 cities and provinces. The inspections, which covered more than 740 hospitals and medical facilities nationwide, focused on the supply, return, receipt, use, administration, and dispensing of these drugs.

The medical community had previously voiced concerns about the growing stringency of regulatory measures. The Korean College of Ob & Gyn (KCOG), representing ob-gyn clinic operators, criticized the move to classify etomidate as a narcotic at its recent spring meeting, calling it excessive regulation.

KCOG President Kim Jae-yoo warned that over-regulating a drug with low abuse potential could lead to unnecessary administrative burdens, treatment delays in emergencies, and negative effects on the healthcare field. He also emphasized that such measures infringe on medical autonomy.

“Etomidate has been used clinically for about 50 years. Unlike propofol, it does not induce euphoria, and its adrenal suppression side effect with repeated use limits its application by healthcare providers,” the group said. “Post-use nausea and vomiting are common, which means it lacks the ‘positive reward effect’ typically associated with narcotic abuse.”

KCOG further noted that etomidate is not classified as a narcotic in developed countries such as the U.S. and those in Europe, and that problematic cases in Korea have been rare. The group argued that there is insufficient scientific and clinical justification for its urgent reclassification.

While strengthening drug management is necessary, it must be done appropriately, KCOG added. “Rather than targeting specialty drugs like etomidate, thorough management of existing narcotics such as propofol, which already shows high abuse rates, should be prioritized. A more realistic and effective approach would be to screen patients and physicians for suspected misuse and to enhance assessments of appropriate drug use.”