The National Food and Drug Administration recently issued a notice stating that based on the evaluation results of adverse drug reactions, in order to further ensure the safety of public medication, The National Food and Drug Administration has decided to uniformly revise the content of the instructions for betahistine preparations (including betahistine mesylate tablets, betahistine hydrochloride tablets, betahistine hydrochloride oral solution, betahistine hydrochloride injection, betahistine hydrochloride sodium chloride injection, and betahistine hydrochloride injection) according to the announcement, The marketing license holders of the above-mentioned drugs shall, in accordance with the relevant provisions of the "Drug Registration Management Measures" and in accordance with the revised requirements of the instructions for betahistine preparations, report to the provincial drug regulatory department for filing before September 7, 2023. If the revised content involves drug labeling, it should be revised together, and the instructions and other contents of the label should be consistent with the original approved content. Drugs produced since the date of record keeping shall not continue to use the original Medication package insert. The holder of the drug marketing license shall replace the Medication package insert and labels that have left the factory within 9 months after filing. Holders of drug marketing licenses should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to promote and train drug use and safety issues, and guide physicians and pharmacists in rational drug use. The announcement stressed that clinicians and pharmacists should carefully read the revised contents of the above Medication package insert, and when selecting drugs, they should conduct full benefit/risk analysis according to the newly revised insert. Patients should carefully read the Medication package insert before taking drugs, and those who use prescription drugs should strictly follow the doctor's instructions. In addition, the provincial-level drug supervision and management department should urge the holders of drug marketing licenses for the aforementioned drugs in the administrative region to revise the corresponding instructions and replace labels and instructions as required, and strictly investigate and punish illegal and irregular behaviors in accordance with the law. (Outlook New Era Network)
Edit：feiyi Responsible editor：yifei
Source：people.cn
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