What Are the Most Common Nimesulide Side Effects?

A report on the "International Forum on Children's Safe Use of Medicine 2010" on November 26, 2010 stated that "Nimesul has been used in children with fever to cause damage to the central nervous system and liver. A chemical name" Nimesulide's antipyretic drug has been pushed to the forefront of drug safety concerns. This incident is known as the "Nimesulide Incident." On May 20, 2011, the State Food and Drug Administration issued a notice. Amends Nimesulide's instructions and bans Nimesulide oral preparations for children under 12 years of age, which will impact Kangzhi Pharmaceuticals.

Nimesulide incident

A report on the "International Forum on Children's Safe Use of Medicine 2010" on November 26, 2010 stated that "

1. At the "International Forum on Children's Safe Use of Medicine 2010" held in Beijing in November 2010, some experts cited China

1. A pharmacy staff member said that Nimesulide has a strong drug effect and a good antipyretic effect. Generally, children will have a fever of 38 degrees or more, and parents will come to buy it when they do not have a fever. If the child's fever is not severe, or if the child has not used Nimesulide, the pharmacy will not actively recommend parents to buy it.

2,

Beijing Children's Drug Safety International Forum

1. Expert of the National Rational Drug Monitoring System of the Ministry of Health

1. This "Nimesulide" storm originated from the "Beijing Children's Medication Safety International Forum" held in Beijing on November 26, 2010. Experts' concerns about the safety of Nimesulide were recently exposed by CCTV. In 2011, Nimesulide produced the largest domestic production and sales company, Kangzhi Pharmaceutical, on the grounds of "unfair competition".

After more than a month of silence in the "Nimesulide" incident, a new situation broke out yesterday. Over the past two days, many media across the country, including the Yangcheng Evening News, have received an anonymous e-mail called "Report Materials". The e-mail stated in the name of the report that "the incident of Nimesulide's safety hype that once caused the public's psychological panic was a commercial war carefully planned by a multinational pharmaceutical company of Nimesulide's competitors.

CCTV report

On November 26, 2010, CCTV News Channel broadcast a report on the "International Forum on Children's Safe Use of Medicine 2010". The report states: "Nimesul is used when children have fever,

1. The "Nimesulide adverse reaction" incident, which was so popular, had an unexpected turn. Nimesulide manufacturer Hainan Kangzhi Pharmaceutical Co., Ltd. issued a statement saying that the report on the drug Nimesulide "is a subjective assertion of some ulterior motives, aimed at targeting" Ruizhiqing "(Nimesulide Particles, produced by Kangzhi Pharmaceutical). The chairman of Kangzhi Pharmaceutical even pointed out that the behind-the-scenes planning of the incident was Johnson & Johnson, a multinational company, and said that he had reported Johnson & Johnson's "unfair competition" to the Hainan Provincial Administration for Industry and Commerce.

2. There have been frequent reports of the children's antipyretic drug Nimesulide "severe liver injury can cause death." There have even been reports that directly named "Ruizhiqing" and called it "life-preventing antipyretic drug", which triggered this series of reports. Yes, a report on the "International Forum on Children's Safe Use of Medicine 2010" broadcasted by CCTV News Channel on November 26, 2010. The report stated that "Nimesul is used in children to reduce fever and cause damage to the central nervous system and liver. There have been frequent cases. According to the China Adverse Drug Surveillance Center, Nimesulide has experienced thousands of adverse events and even several deaths in the 6 years since its launch in China. "

3. Kangzhi Pharmaceutical clarified that according to the "Adverse Drug Reaction Information Notification" issued by the National Center for Adverse Drug Reaction Monitoring, there has been no adverse drug reaction information related to nimesulide in China for the past ten years. Ruizhiqing has never been listed for nine years. Serious adverse reactions have occurred. Kangzhi Pharmaceutical issued a solemn statement through Hainan Tianhao Law Firm, saying that "in the recent period, some people with ulterior motives have spread through various media and unreasonably enlarged the side effects of 'Nimesulide Granules', thereby maliciously denigrating 'Ruizhi' The purpose of the 'product reputation'. The statement also stated that it would reserve the right to pursue its legal responsibility.

4. At present, Kangzhi Pharmaceutical has relevant evidence. One of them is that after the "International Forum on Children's Safe Use of Medicine 2010" on November 26, 2010, some manufacturers sent warning text messages to doctors in major hospitals in the name of the safety of children's medicine, saying that the ingredients of "Nimesulide" were suspected. Not safe. And then the Johnson & Johnson's official website clearly appeared to disable the "Nimesulide" sign, "Now that sign has been removed, but we retain the evidence."

The stock price of Kangzhi Pharmaceutical has also been affected by this. Since the opening on the 15th, the stock price has fallen for several consecutive days.

According to the prospectus of Kangzhi Pharmaceutical, Ruizhiqing's sales gross profit in 2007, 2008 and 2009 accounted for 72.89%, 84.67% and 89.54% of the company's gross sales profit in the same period, that is, Ruizhiqing The production and sales status basically determines the company's income and profitability.

Kangzhi Pharmaceutical's stock price fell sharply by 8.49% yesterday. The transaction data on the same day showed that 570 million yuan was traded throughout the day, and there were obvious signs of agency fleeing. Only 5 institutions' special seats sold more than 200 million yuan. In fact, Kangzhi Pharmaceutical temporarily suspended its trading since the market opened on February 14, 2011, and clarified it twice on its official website. However, after the resumption of trading that afternoon, the stock price began to fall. As of yesterday's close, 6 transactions Japan's stock price fell nearly 16%, and the market value disappeared by 1.149 billion yuan.

Nimesulide Incident Update

On May 20, 2011, the State Administration of Food and Drug Administration stated that the report on the adverse reactions of "Nimesulide" oral preparations, domestic and foreign research and supervision, and expert opinions issued the "On Strengthening Nimesulide Oral Preparations" Notice of Use Management, requiring "Nimesulide" oral preparations to be banned for children under 12 years of age; as second-line anti-inflammatory and analgesic drugs, only in the case of failure of at least one other non-steroidal anti-inflammatory drug Use; indications are limited to the treatment of chronic arthritis pain such as osteoarthritis, pain after surgery and acute trauma, and primary dysmenorrhea; the maximum single dose does not exceed 100 mg, and the course of treatment cannot exceed 15 days, and should be based on Clinical practice uses the smallest effective dose and shortest course of treatment to reduce the occurrence of adverse drug reactions.

The State Drug Administration also reminded that nimesulide is a prescription drug and must be used under the guidance of a doctor. It is recommended that clinicians fully consider the patient's condition and the possible risks in the medication when choosing the medication, weigh the advantages and disadvantages, and inform the patient of the potential medication risk, and pay attention to monitoring the patient's liver, kidney function and blood routine during the continuous medication And other indicators, abnormalities should be immediately discontinued or take appropriate treatment measures.

Major effects of Nimesulide

According to the data, the leading product of Kangzhi Pharmaceutical is children's antipyretic and analgesic drug Ruizhiqing (Nimesulide granules). Kangzhi Pharmaceutical has stated in the corporate risk section of its prospectus that if Nimesulide is formulated The suspension of sales will adversely affect the company's production and operations. "

According to the first quarter report this year, affected by the incident, Nimesulide pellet sales revenue fell 42% year-on-year. Kangzhi Pharmaceutical achieved a net profit of 11.203 million yuan, a significant year-on-year decrease of 55.21%. In the secondary market, the stock price of Kangzhi Pharmaceuticals, which has suffered a major business crisis, is also declining. Last Friday only closed at 19.25 yuan. ^[4]