Adverse Drug Reactions Announced as Normal

It is not difficult to find that the SFDA's adverse reaction notification is a clue to "sweeping out" the black swan. Although Jinling Pharmaceuticals "falls" due to adverse reaction events, the drug sector in 2012 shows that all listed drug companies and Investors' reactions to adverse reactions have become dull. In fact, adverse reactions are not uncommon in the medical sector itself. Regular reporting of adverse drug reactions is also an international practice.

"In the field of professional medicine, adverse reactions are normal, and adverse reactions to drugs do not mean that there is a problem with the quality of drugs. Drugs can be accidentally stored and transported, leading to the rupture of vials and contamination of drugs. Stepping on adverse reactions to 'landmines', drug companies have adopted clinical trials at the same time as the previous period, and they have to conduct systematic clinical safety reevaluations and conduct comprehensive safety assessments to reduce the incidence of adverse events."

Take an ambroxol hydrochloride injection as an example. According to the notification of the Food and Drug Administration, from January 1, 2011 to December 31, 2011, the case reporting database of the National Center for the Monitoring of Adverse Reactions received altogether about ambroxol hydrochloride injections. 2973 cases were reported as reaction/event cases, 169 cases were reported as serious cases. The circular recommends that the medical units prudently use drugs, and production companies should revise and improve drug descriptions and strengthen post-market drug surveillance.

The listed company Kang Enbei said that sales of the company's ambroxol hydrochloride injection was only over 1.9 million yuan in 2011, accounting for 0.09% of the total sales. From January to August this year, the total sales of the product was only more than 1.8 million yuan. The impact is tiny.

Aspartic acid potassium magnesium injection is because of the safety issues are more prominent, more severe cases of allergic reactions were included in the notification list by the Food and Drug Administration, however, the listed companies with this injection lot number are either not put into production or sales are very small. Therefore, the market has almost no response to this.

More recent domestic accidents are injections or important injections. This is also related to the nature of the drug itself. There are several types of administration, external use, oral administration, injection, etc. Injection is the most dangerous. The injection is divided into intramuscular injection, subcutaneous injection, and intravenous injection. Intravenous injection is the most dangerous. "Zhaochuang said that the medical and pharmaceutical industry analyst Zhao Zhen said.

He believes: “The Chinese medicine was caused by the complex composition of Chinese medicines, some impurities we didn’t figure out ourselves, and the state had no relevant regulations for some impurities. These are likely to cause adverse reactions. There is also the possibility that the biopharmaceutical industry is more prone to accidents. Because the technology is relatively new, there are fewer clinical validations, and the clinical sample size is not enough, and the unknown adverse reactions are not well understood."

The State Food and Drug Administration publishes an adverse drug reaction information bulletin to help people from all walks of life to raise awareness and strengthen vigilance. The Food and Drug Administration said that the publication of the “Information Bulletin on Adverse Drug Reactions” will help improve the correct understanding of adverse drug reactions among medical workers, improve the level of clinical care, and avoid the occurrence of serious adverse drug reactions. At the same time, it reminds the producers of notified varieties to strengthen the follow-up monitoring of their production varieties, and to ensure the safe use of drugs by the people.