CFDA reminds us to pay attention to the risk of Chinese and Western medicine compound preparation

Source: CFDA 2015-6-29 the State Food and Drug Administration recently issued the 67th issue of adverse drug reaction information notice to remind the risk of Chinese and Western medicine compound preparations Some of the Chinese and Western medicine compound preparations are widely used in clinical practice, but the composition of such preparations is complex Besides traditional Chinese medicine, there are one or more chemical components, so the safety of the chemical components is easy to be ignored in clinical use It includes adverse reactions caused by chemical ingredients, or combined use with drugs containing the same ingredients or with similar efficacy, which is easy to cause overdose use of components or toxic synergy, increasing the risk of drug use This report is about the risk of adverse reactions such as hematuria caused by Ganmaoqing tablet (capsule) and the risk of allergic reaction of Naoluotong capsule Ganmaoqing tablet (capsule) contains three chemical components of acetaminophen, chlorphenamine maleate, Moroxydine Hydrochloride, and six traditional Chinese medicine components of nanbanlangen, Daqingye, marigold plate, Gangmei, shansesame and Andrographis It is mainly used for wind heat, cold, fever, headache, stuffy nose, sneeze, sore throat, and general pain Monitoring data shows that there are many adverse reactions of Ganmaoqing tablets (capsules) to hematuria; when combined with drugs with the same composition or similar efficacy, it may increase the risk of serious adverse reactions Naoluotong capsule contains topicetone hydrochloride, vitamin B6, methylhesperidin, Salvia miltiorrhiza extract, chuanxiong extract and Huangqi extract It is mainly used for headache, vertigo, hemiplegia, limb numbness and fatigue caused by qi deficiency and blood stasis syndrome of various cerebrovascular diseases such as cerebral thrombosis, cerebral arteriosclerosis and stroke sequelae The allergic reaction of Naoluotong capsule may be mainly related to the components of topiramate hydrochloride According to the monitoring data at home and abroad, Naoluotong capsule and its main active ingredient, piperone hydrochloride, have been reported more allergic reactions, and the risk of serious allergic reactions deserves attention According to the analysis and evaluation, the State Food and drug administration suggested that: (1) before using Ganmaoqing tablet (capsule), the medical staff and patients should read the drug manual carefully, pay attention to the risk of adverse reactions in blood and urine, and try to avoid the combined use of drugs containing paracetamol, chlorphenamine maleate, Moroxydine Hydrochloride and other components （2） Before using Naoluotong capsule, medical staff and patients should read the drug manual carefully, fully understand the drug risk of Naoluotong capsule, and understand the disease history and drug history of patients in detail, so as to avoid or reduce the occurrence of allergic adverse reactions In case of allergic reaction during the course of taking medicine, the patient should stop taking medicine immediately (3) the relevant manufacturers shall improve the safety information of the drug instructions as soon as possible, add or revise the warning words, adverse reactions, precautions, taboos, medication for special groups and drug interactions, etc.; at the same time, they shall strengthen the monitoring of adverse reactions and the publicity of clinical rational medication, take effective measures to reduce the risk of medication.