Once banned from selling "star drugs", now they are still jumping in the corner

From the perspective of adverse risk monitoring, in the past, compared with Europe and the United States, China had very limited channels for obtaining adverse drug reactions.
It mainly relied on the adverse reaction monitoring center to collect post-market adverse reaction reports.
It was difficult to establish a complete post-market risk management system for drugs.
Provide adequate support for regulatory agencies to identify risk signals
.

·Therefore, the original CFDA’s information bulletin on sibutramine adverse drug reactions released in 2010 showed that the National Adverse Reaction Monitoring Center collected a total of 298 cases of sibutril between January 1, 2004 and January 15, 2010.
Relevant adverse reaction reports are clearly stated, and most of them are those already stated in the instructions, and there are no deaths1
.

·In contrast, from the launch to 2010, the FDA Adverse Event Reporting Database (FAERS) received 5507 reports of sibutramine-related adverse events, of which 188 were reports of severe cardiovascular and stroke, and deaths caused by cardiovascular diseases There are a total of 42 cases2
.
After receiving a serious adverse event report, the FDA immediately conducted an analysis
.
Although obesity is also a cause of cardiovascular disease, FAERS analysis results still cannot rule out that sibutramine may be causally associated with an increased risk of cardiovascular disease
.
Therefore, the FDA has decided to continue to strictly monitor the adverse events related to sibutramine and adopt more methods to analyze and evaluate its cardiovascular risk
.

In recent years, with the advancement of drug regulatory reforms, China has paid more attention to "post-marketing clinical trials" and "adverse reaction monitoring", clarified the concept that companies are the "first responsible person" for drug safety, and further improved drug registration management and post-marketing supervision Relevant regulations and measures, and improve the monitoring and emergency response of adverse reactions and adverse events
.
On December 1, 2019, China’s new version of the "Drug Administration Law" came into effect.
Article 30 stipulates that "The holder of a drug marketing authorization shall, in accordance with the provisions of this Law, conduct non-clinical research, clinical trials, production and operation, and post-marketing of drugs.
Responsibility for research, adverse reaction monitoring, reporting and handling.
.
.
"
.

From a supervisory point of view, currently, in the food and drug sector, the testing methods and levels of testing in some areas are relatively backward, and there are still some blank areas for testing
.
These blank areas are high-risk areas where food and drug safety risks frequently occur
.
At the same time, there are also cases where companies have different implementation efforts
.
After the ban on sales was released, some products of the same type of sibutramine, such as "Aoquqing" and "Xinfenmeilin", continued to be sold for a period of time
.
Nowadays, there are also fake weight-loss drugs that are wholesale, distributed, retailed, and paid through e-commerce platforms and other online channels through live streaming and micro-business channels
.

On the one hand, in terms of actually solving the problem of adverse reactions, have the relevant companies strictly implemented the recall and destruction of sibutramine that had been on the market? Why is the continuous supply of sibutramine flowing into the market because of the ban on the sale of related raw materials? Have e-commerce platforms and other networks fulfilled their corresponding obligations? Should the weight loss marketing that has been bombarded on the Internet platform be managed?

On the other hand, for consumers, it is more necessary to distinguish and carefully purchase products purchased from difficult-to-supervise channels, and to use monitoring and reporting tools to provide timely feedback on adverse reactions encountered during medication
.

In short, to combat illegal drug additions, the implementation of drug supervision and management has never been achieved by the efforts of one party
.
Before the illegal incident is eliminated, we still need to keep our eyes open
.