MFDS Issues Draft Amendment Order for Opicapone Oral Formulations to Update Adverse Reaction Precautions

The Ministry of Food and Drug Safety (MFDS) has prepared a draft amendment order for oral formulations containing the ingredient Opicapone. The draft reflects the results of a recent re‑examination and aims to incorporate post‑marketing adverse cases into the product's approved conditions. The primary change proposed in the amendment concerns the "Precautions for Use" section, specifically item 3 "Adverse Reactions," which will be updated to strengthen safety warnings for the drug. MFDS has opened a public comment period, inviting stakeholders to submit any opinions along with specific reasons and supporting documents. The information was reported on the Medicine Safety Nation portal on the 6th of the month, indicating the agency’s effort to enhance drug safety monitoring after domestic market launch.