Food and Drug Administration reminds Shendan injection to be used with serious adverse reactions

The State Food and Drug Administration issued a circular on the 23rd to remind medical staff and patients of serious adverse reactions such as anaphylactic shock and dyspnea caused by Xiangdan injection.

The main components of Xiangdan injection are Dangxiang and Salvia miltiorrhiza. Its function is to dilate blood vessels and increase coronary blood flow. Clinically used for angina, can also be used for myocardial infarction.

According to statistics, in 2011, 2,413 cases of Xiangdan injection were reported in the case report database of the National Center for Adverse Drug Reaction Monitoring, and 180 cases of severe adverse reactions were reported. Most of the serious adverse drug reactions occurred on the first day of drug use, mainly manifested as allergy-like reactions, anaphylactic shock, and dyspnea.

The State Administration of Food and Drugs recommends that medical personnel should carefully inquire about the patient’s allergy history before using it, and those with history of drug allergy should be banned. Should strengthen drug monitoring, find abnormalities, stop the drug immediately, and use active rescue measures to treat patients.

Today's visit

The reporter searched for the production of Xiangdan injection company and discovered as many as dozens of companies, including Shenwei Pharmaceutical Co., Ltd. and Yunnan Baiyao Group Co., Ltd., and other famous pharmaceutical companies.

In the morning, Liu Tiejun, senior director of production technology at Shenwei Pharmaceutical Co., Ltd., stated that the company revised its drug product specification on November 10 last year, raised the use of drug taboos to four items, and raised the number of doctors' attention to 13 items. Rational use of drugs provides the basis. "Before the drug taboos and precautions were less than now," Liu Tiejun said.

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