Minutes of the 6th Drug Safety Measures Council Meeting, FY2026
Overview
At its meeting on August 27, 2026, the council deliberated on the risk classification of propiverine hydrochloride “Bapp for Lady” and reported on a proposed revision to the electronic package insert for riociguat. The council approved a policy to classify propiverine hydrochloride as a Designated Class II OTC drug, with stronger warnings and post-decision discussions with relevant academic societies, and to proceed to public comment. For riociguat, the council reported a policy to add a precaution about concomitant use with strong P-gp/BCRP inhibitors to the electronic package insert.
Key points
- The policy to classify propiverine hydrochloride as a Designated Class II OTC drug, subject to conditions, was approved.
- A total of 147 cases of inappropriate use were reported in the proper-use survey.
- A policy to add a precaution about concomitant use with strong P-gp/BCRP inhibitors to riociguat’s electronic package insert was reported.
Overview
The council met on August 27, 2026. Agenda item 1 covered the risk classification of OTC medicines, and agenda item 2 covered a proposed revision to the riociguat package insert. Under agenda item 1, the council considered the risk classification of propiverine hydrochloride, for which the post-marketing survey had been completed.
For propiverine hydrochloride, the approved policy for reclassification as a Designated Class II OTC drug included emphasizing warnings and holding post-decision discussions with academic societies. Based on the deliberation, the public comment process will proceed, after which the matter is scheduled for deliberation at the next Drug Safety Measures Council meeting, taking the results into account.
Impact
The proposed revision to riociguat’s electronic package insert would retain a precaution about concomitant use with strong P-gp/BCRP inhibitors and use wording that does not limit the inhibitors to cyclosporine.
Details
“Bapp for Lady” is indicated for urinary urgency, frequent urination accompanied by urgency, and urinary leakage. Adult women aged 15 to under 70 take one tablet once daily after a meal. In the special survey, adverse reactions occurred in 372 cases, comprising 529 events, among 3,652 cases; there were no serious cases. In the general survey, 56 adverse reaction events in 35 cases were reported, including one case of urinary retention judged serious.
The 147 inappropriate-use cases comprised 70 sales to people aged 70 or older, 53 uses of contraindicated concomitant medicines, 5 sales to men, 17 uses by people with contraindicated conditions, and 2 other cases. After the information was obtained, measures were taken to prevent recurrence by providing proper-use information to pharmacists and others; the incidence showed a declining trend in the latter half of the survey period.
The expert witness stated that the adverse reaction incidence was 10% and expressed concern about urinary retention. Committee members raised concerns about information provision and safety measures, improvements to packaging and materials, and confirmation of academic society views. After the policy to classify the product as a Designated Class II OTC drug was approved, the secretariat said it would consider warning methods with the company and academic society experts.
For riociguat, the electronic package inserts for the relevant products were revised on February 10, 2026, following removal of the contraindication on concomitant use with ensitrelvir and lonafarnib. The report explained the proposed precaution about concomitant use with strong P-gp/BCRP inhibitors, based on the possibility of reduced clearance, and described serious blood-pressure-lowering events reported overseas when riociguat was used with cyclosporine.