Drug Administration reported high incidence of serious adverse events in anti-infective drugs

The State Food and Drug Administration issued an annual monitoring report to remind middle-aged and old people that they should strengthen monitoring of medications. The State Food and Drug Administration issued an annual report on adverse drug reaction monitoring in 2011. In 2011, the National Center for Adverse Drug Reaction Monitoring received a total of adverse drug reactions/events. There were 852,799 reports, of which anti-infectives in chemical products ranked first in total adverse events/events and serious adverse events/events reports. The top three were cephalosporins, penicillins, and quinolones. The survey also found that the proportion of middle-aged and elderly patients in the serious adverse reactions/events report increased, reminding the middle-aged and elderly people to strengthen medication monitoring.

The risk of injection of traditional Chinese medicine injections is high. The State Administration of Food and Drugs introduced the report to report on the adverse drug reactions of the year from the three aspects of the general situation of adverse drug reaction reports, statistical analysis of adverse drug reaction/event reports, and drug risk control measures. In the 2011 reports of adverse drug reactions/incidents in 2011, there were 145,769 new and serious ADR/incident reports, which accounted for 17.1% of the total number of reports in the same period, which was basically the same as in 2010.

The statistical analysis of adverse drug reactions/event reports in 2011 showed that traditional Chinese medicine injections are still the main risk for Chinese medicine preparations. The top 3 drugs ranked in the number of adverse reactions/incidents reported in 2011 were Qingkailing injection, Shuanghuanglian Injection and Senate respectively. Mai injection.

In addition, the reported rates of cephalosporins, penicillins, and quinolones were 34.8%, 14.0%, and 12.2%, respectively, and the safety risk for intravenous administration was higher. This suggests that choosing a reasonable route of administration can reduce the adverse reaction rate. .

According to the report, in 2011, the State Food and Drug Administration conducted analysis and evaluation of adverse drug reaction monitoring data, and adopted relevant management measures for drugs with potential safety hazards.

The first is the release of drug safety warning information. A total of 9 issues of the "ADR Report" were issued throughout the year, and 9 (class) drug safety information was reported. Published the "Pharmacovigilance Alert" 11 issues, reported more than 60 kinds of drug safety information; followed by the modification of isotretinoin preparations, nimesulide oral preparation product instructions, clear tips on drug risks; third is to strengthen the release notice Nimesulide oral administration administration; Fourth, withdrawal of pharmaceutical preparations containing dextropropoxyphene, amitrizinolubaxin tablets (compound amikacin tablets), clenbuterol hydrochloride tablets, or drug approval documents Drug standards; Fifth, interviews are conducted on production companies that have a high incidence of adverse reactions such as progesterone injections.