NMPA Mandates "Do Not Drive" Warning on Cold Remedy Oral Preparations

On July 20, the National Medical Products Administration (NMPA) issued Announcement No. 66, mandating that all oral formulations of Ganmaoling (including granules, capsules, tablets, and tea preparations) must uniformly add warnings such as “Do not operate aircraft, motor vehicles, or vessels during treatment” to their package inserts. Additionally, the “Adverse Reactions” section of the labeling must be updated to include various adverse reactions reported in post-marketing surveillance data. The reported adverse reactions involve multiple organ systems: - **Skin and subcutaneous tissue disorders**: rash, pruritus, urticaria, hyperhidrosis, allergic dermatitis, skin swelling, as well as isolated cases of erythema multiforme and allergic purpura; - **Nervous system and psychiatric disorders**: somnolence, insomnia, irritability, fatigue, drowsiness, dizziness, headache, paresthesia, bitter taste in mouth, and tremor; - **General disorders**: thirst, asthenia, chest discomfort, fever, edema, chills, and pain; - **Gastrointestinal disorders**: nausea, vomiting, dry mouth, diarrhea, abdominal pain, abdominal discomfort, bloating, acid reflux, dyspepsia, and constipation, with rare cases of gastrointestinal bleeding; - **Hepatobiliary disorders**: abnormal liver function, liver injury, and jaundice; prolonged high-dose use may lead to liver dysfunction, and overdose of acetaminophen can cause severe hepatotoxicity; - **Renal and urinary disorders**: dysuria, urinary frequency, renal impairment, with isolated cases of hematuria; long-term high-dose use may result in abnormal kidney function; - **Other adverse reactions**: hypersensitivity reactions, palpitations, flushing, dyspnea, tachypnea, vertigo, decreased appetite, tinnitus, muscle weakness, elevated blood pressure, granulocytopenia, eyelid edema, and isolated reports of blurred vision and anaphylactic shock. Ganmaoling is a compound formulation containing both traditional Chinese and Western medicines, including acetaminophen, chlorpheniramine maleate, and caffeine. Chlorpheniramine maleate exerts central nervous system depressant effects, which may cause drowsiness, fatigue, and impaired attention—potentially affecting reaction time and judgment while driving. According to pharmacy representatives, this labeling revision is unlikely to significantly impact retail sales. These medications are typically used short-term and on an as-needed basis during cold seasons, unlike chronic disease medications requiring long-term use. Moreover, non-sedating alternative cold remedies are already available on the market to meet the needs of drivers and individuals in occupations requiring alertness, ensuring manageable consumer diversion.