Minutes of the 3rd Drug Safety Investigation Council Meeting, FY2026
Overview
At the 3rd Drug Safety Investigation Council meeting in FY2026, the council unanimously resolved to classify the over-the-counter drug Colpermin, recorded in the resolution as peppermint oil, as a Class 2 drug. No serious adverse reactions were identified in the post-marketing survey, and the classification was also considered in light of Selekino S, which has similar indications and is classified as a Class 2 drug. The public comment procedure will proceed, after which the Pharmaceuticals and Medical Devices Safety Measures Committee is scheduled to deliberate based on the results and the council's deliberation.
Key points
- Peppermint oil, an over-the-counter drug, was unanimously resolved to be classified as a Class 2 drug.
- No serious adverse reactions were identified in the post-marketing survey.
- The overall rate of inappropriate use was 7.3 percent.
- The public comment procedure will proceed, followed by deliberation by the Pharmaceuticals and Medical Devices Safety Measures Committee.
Overview
The Safety Investigation Council considered the risk classification of Colpermin, a Class 1 drug, after its post-marketing survey was completed. The drug received marketing approval on August 31, 2021, and is currently marketed as a Class 1 drug.
Based on the absence of confirmed serious adverse reactions and the fact that Selekino S, which has similar indications, is a Class 2 drug, the secretariat proposed classifying it as a Class 2 drug.
Impact
Class 2 drugs are sold by pharmacists or registered sellers, and providing information is an obligation to make efforts. If the drug is reclassified from Class 1 to Class 2, the requirements for professional assistance and information provision at the time of sale will change.
Details
The indications are the relief of recurrent or alternating diarrhea and constipation accompanied by abdominal pain or abdominal discomfort associated with irritable bowel syndrome, limited to people who have received a doctor's diagnosis and treatment. Adults aged 15 or older should take one capsule per dose three times daily before meals or between meals.
In the special survey, 45 cases involving 62 adverse reaction events were reported among 1,037 cases, but there were no serious cases. In the general survey, there were 5 adverse reaction events in 3 cases, and these were also not serious.
Inappropriate use consisted of 61 cases and 5.9 percent with no history of diagnosis or treatment, 5 cases and 0.5 percent with a history of colorectal cancer or inflammatory bowel disease, including Crohn's disease and ulcerative colitis, 10 cases and 1 percent involving concomitant use of antacids, and 3 cases and 0.3 percent involving use outside the specified directions and dosage. None involved serious adverse reactions, and all cases recovered.
Five of the six committee members attended, meeting the quorum requirement. After the resolution, the secretariat stated that it would conduct a public comment procedure and that the Pharmaceuticals and Medical Devices Safety Measures Committee would deliberate based on the results and the council's deliberation.