Canchi pharmaceutical industry or encounter crisis Nimesulide swept around

The recent CCTV "news Live Room" on the nimesulide children drug adverse reaction of the early warning, the domestic largest nimesulide preparation manufacturer Canchi Pharmaceutical industry (300086.　　SZ) again to the cusp. According to our correspondent survey to understand that, although the National ADR Monitoring Center website does not have detailed adverse reaction information inquiries, but there are more than 20 medical papers dedicated to reporting ADR cases, published in 14 authoritative academic journals, including the National ADR Monitoring Center sponsored the Chinese Journal of Drug Alert.　　Involving more than 20 cases, of which children because of the use of Canchi drugs leading products Rui Zhi Qing, a case of multiple organ function injury, one case caused serious liver damage and death. In recent years, some local media have also reported that children have suffered from liver poisoning and myasthenia gravis due to the use of nimesulide. Some industry insiders called the "melamine" in the child Fever medicine. Shenzhen, a brokerage pharmaceutical industry researcher pointed out that, if the adverse effects caused by nimesulide further aroused widespread concern of the community, Canchi Pharmaceutical and other companies in the production of the company will face greater operational risk.　　In fact, early in the IPO, Societe Generale Securities and other securities companies in the report prompted Canchi drug products nimesulide potential security risks.　　CCTV reported that November 26, 2010, in the state Food and Drug Administration of the leadership to participate in the Beijing Children's Drug Safety International Forum, from the United States and the United Kingdom children's experts, as well as the national nearly hundred pediatric scholars, professors unanimously reminded parents, in children's choice of fever medication to be cautious with nimesulide.　　In addition to CCTV, Guangming, science and technology daily, health, reference information, and other authoritative media have been broadcast the meeting, and the Nimesulide, aspirin, an naijin and other child antipyretic drugs have a major security risks have been comprehensively reported, especially for the nimesulide in recent years many adverse events gave warning.　　reported that the ADR Monitoring Center reported that nimesulide in the treatment of children with analgesic fever has been thousands of cases of adverse events, and even a number of death cases. The report sparked concern about the safety and operational risks of drug use by Canchi Pharmaceutical, the largest drug producer in the industry. The Canchi pharmaceutical industry, which has been bucking the trend rally, has also peaked and continues to fall.　　This time, however, the Canchi pharmaceutical industry chose silence. May 2010, the Canchi pharmaceutical industry before and after the listing, about Rui Zhi Qing side effects of too much doubt is rampant, there are media directed to Canchi pharmaceutical industry to eliminate foreign drugs to poison rural children.　　Public opinion under the pressure of the Canchi pharmaceutical industry on April 10 on its website issued a statement, Hainan Province ADR Monitoring Center for its special to the regulatory authorities on the safety of Rui Zhi Qing drugs to make inquiries again for the application made an approval document. In this official reply, the words "Nimesulide" are as follows: "ADR information bulletin published by the National ADR Monitoring Center of the retrieved country" (November 2001-March 2010, no information bulletin on adverse reactions related to nimesulide, paracetamol and ibuprofen. In July, the Canchi of the pharmaceutical industry reiterated that "after retrieval, there has been no information bulletin on the adverse reactions of nimesulide in China in recent decades." "Because the bulletin mentioned the Hainan Province ADR Monitoring Center and the National ADR Monitoring Center and other government agencies, Canchi pharmaceutical industry successfully resolved the toxic side of the crisis.　　However, people's doubts have not completely eliminated, Canchi pharmaceutical industry on the day of the listing is below the IPO price, creating the industry board break precedent. Passage of time, the CCTV warning, Canchi drug has not listed high pressure, silent response quite obvious calmly. The reporter calls Canchi medicine industry, its dong secret office personage still insists, at present did not receive any official bad feedback. and has been associated with the Hainan adverse drug reaction Monitoring Center has not been related to information feedback.　　For CCTV and other mainstream media warning, the person slightly hesitated, "This is the side effects of drugs," said lightly. 20 cases of liver damage caused by nimesulide so, what is the side effect of nimesulide? Does the domestic clinical application adverse reaction situation how?　　Is it true that there is no record of the Canchi pharmaceutical industry? Reporter Login to the national drug adverse Reaction Monitoring Center website, simple search "nimesulide" or "Rui Zhi Qing", the former only four foreign agencies of the assessment of the report, there is no domestic adverse reaction record; the latter has no information at all. The reporter searched the site again, and eventually found two articles on the Chinese drug Alert, a magazine sponsored by the center. A report entitled "1 cases of systemic edema caused by nimesulide capsules", the author is a Bangbu of the third People's Hospital affiliated to Southeast University, Cheng June, etc. 3 people; another article for the "Nimesulide granules induced edema 7 cases", the author of Zibo City, Shandong Province Hospital pharmacy Sijiang and other 2 people, are published in the "China Drug Alert" magazine, Are the 12th and 7th phases of 2010 respectively.　　However, the "China Drug Alert" page has only two titles and authors, details of which are not uploaded. There is no record of adverse reactions on the site of the adverse Reaction Monitoring Centre, and the publication of reports of adverse reactions in its journals is questionable.　　However, along this clue, the reporter searched the professional periodical papers, the result is very heavy!　　In less than one hours of network search, the reporter found 16 published in the medical professional journals of professional papers, the reaction of the domestic nimesulide caused by liver damage, exhaustion, multiple organ function injury, death and other cases. This, the 1th case of the domestic report and the application of Seretide-related liver damage cases, by the first military University of the Pearl River Hospital Guan Ying, Xu Feng in 2001 found and reported in the Journal of Drug Adverse Reactions 2002 2nd. The article entitled "The combined use of lomefloxacin, nimesulide and Notoginseng to cause liver damage" refers to the appearance of a 22-year-old female patient on February 8, 2001, following the use of Lomefloxacin, Nimesulide and Notoginseng total glucosides of three drugs on the left hand finger of multiple comminuted fractures.Rash, and then found abnormal liver function, therefore "we believe that this case of hepatitis should be associated with lomefloxacin, Nimesulide and Notoginseng in combination with the cause of hepatitis B activity." As the authoritative Journal of adverse drug reactions in the country, the journal published 5 articles on adverse reactions in Seretide from 2006 to 2009. Respectively: 2006, the 8th volume 3rd Phase Guigang Chinese and Western Medicine Orthopaedic Hospital Shun Chunhui and so on 2 people "Nimesulide to cause hepatitis"; April 2007 9th Volume 2nd Phase IV Medical University Tang du Hospital Army infection Diagnosis and treatment center Wang Linxu and so on 3 people "The nimesulide causes the child acute severe hepatitis death", Referring to the November 14, 2006 1 patients suffering from rheumatoid disease 9-year-old boy after taking nimesulide treatment for 77 days, the emergence of weakness, nausea and jaundice, "consider for drug-induced hepatitis with acute liver failure", after the rescue of invalid eventually died. The paper suggests that "the problem of nimesulide liver toxicity should be highly vigilant"; in the 9th volume 6th of December 2007, the author of Sun Fengxia, Beijing Ditan Hospital, reported that the liver damage caused by nimesulide and its clinical safe use were disclosed, as at August 2007, 15 Clinical reports of nimesulide-related liver injury were retrieved through PubMed and Cnki, in 22 cases. Among them, there were 2 cases in China in 2004, 2006 1 cases, and the youngest was 24 years old. 1 cases of Chinese patients with medication only 1 days caused liver damage; April 2008 10th Volume 2nd, Capital Medical University Xuanwu Hospital emergency department Wangchangyuan and other 4 people, "nimesulide caused multiple organ dysfunction syndrome death," the article refers to March 21, 2007 1 66-year-old male patients with lumbago disease oral nimesulide, 7 days after taking medicine, jaundice and so on, after the gradual emergence of dyspnea, less urine, liver and kidney failure, "consider for the nimesulide caused by multiple organ dysfunction syndrome, after treatment is invalid, the 4th day of Hospitalization death"; June 2009 11th Volume 3rd Capital Medical University affiliated Beijing Friendship Hospital Pharmacy Department Cheng disclosed Nimesulide caused liver damage combined with ascites, April 20, 2008 1 cases of 55-year-old women due to lumbar intervertebral disc protrusion of the individual oral nimesulide, after the abnormal liver function, B-ultrasound found ascites.　　Hospital with suspected drug-associated liver lesion was diagnosed as drug-caused liver damage and ascites with peritoneal infection. In addition, Bengbu Medical College affiliated Hospital pharmacy department Zhu Jinxiu 5 people in the "China Medicine Leader" December 2008 5th Volume 36th Issue "nimesulide oral preparation domestic literature adverse reaction analysis" stressed that, Published reports in various medical journals in the past 1998-2008 years and 11 years collected through the document retrieval system, a total of 19 literatures on adverse reactions of nimesulide orally produced in China were found in 14 periodicals, such as the Journal of Drug adverse Reactions, medicine Herald, drug alert, Chinese New drug journal, etc.　　Among them, the Journal of Drug Adverse Reactions, 4 cases, the Journal of Drug Epidemiology, the medicine leader of the 2 cases, and other magazines reported 1 cases. The results of statistical analysis showed that 20 cases of male patients with adverse reactions were 7 cases,Age 4-67, female patients 13 cases, age 7-71 years old, 10 years old 3 cases, accounting for 15%, of which 1 cases of acute severe liver injury to death. In 20 cases, only 3 cases had combined medical condition.　　The article points out that women, children and the elderly are prone to adverse reactions, mainly liver, kidney function damage, and lead to 2 cases of death, recommended to children, the elderly cautious use of the drug. Rui Zhi Qing has caused a number of serious adverse reactions combined with the above cases, it can be found that the adverse reactions of nimesulide mainly occurred in rheumatism, waist and leg pain and other adult diseases, it seems, and Canchi medicine industry Rui Zhi Qing and other children Drug Association is not.　　However, further retrieval of the reporter found that because of fever to eat Rui Zhi Qing and children's adverse reactions caused by a number of papers, which also involved in fatal cases. The Department of Pathology, teaching and research, Han Songying, Yanbian University, 6 people in the Journal of Clinical and Experimental Pathology, 24th volume, 4th 2008, 1 cases of fatal liver injury caused by Nimesulide, said November 25, 2007, A 9-year-old woman was given a fever by taking a drug at her downstairs pharmacy to buy two drugs, such as Rui Zhi and pseudoephedrine hydrochloride tablets (1I), followed by both instructions for 3 consecutive days. 26th afternoon patients have vomiting, 27th visible face and limbs and other skin spots and bruises, and hematuria. 28th early morning illness aggravating, skin blood stasis point and plaque gradually increase, so into our hospital pediatric treatment.　　When the children were delirious, the hospital diagnosed as acute liver necrosis caused multiple organ function failure, and finally died on 28th around 4 o'clock in the afternoon.　　The article emphasizes that the analysis of this case causes acute liver necrosis, the child also took another one to liver, kidney organs have a certain damage to the drug paracetamol pseudoephedrine tablets (II), thus aggravating the nimesulide drugs for liver damage. In the 8th volume of June 2010, the 3rd issue of the Journal of Bethune Military Medical College, Shijiazhuang PLA 260 Hospital Pediatric Wang Hongyan and other 4 people again disclosed that "nimesulide caused multiple organ dysfunction in neonates 1 cases," refers to a child only 4th due to Fever oral medicine Rui Zhi Qing (nimesulide granule 30mg) 2 times, temperature does not drop.　　The next day, the child jaundice, sexual facial and systemic edema, diapers, such as blood, diagnosis of multiple organ dysfunction. In the 10th phase of 2009, the Shaanxi Medical Journal, the second affiliated Hospital of Shaanxi University of Medicine, Ho (blog) and other 5 people "nimesulide-induced renal adverse reactions in neonates 5 cases," the article means, in 2006-2008, 5 cases of neonatal renal adverse reactions were treated by nimesulide, including male 2 cases, female 3 cases,　　The minimum age of 9d, the largest 25d, the average age of 16d,5 patients with fever after the use of Nimesulide granules after the kidney adverse reactions, acute renal failure in 1 cases, acute renal insufficiency 4 cases. Another doctor told reporters recently encountered cases, a four-month baby, because of upper respiratory infection fever, in the local village health room used antipyretic analgesics "nimesulide granules", the next day in hospital treatment, the third day of hospitalization, the babySudden body skin serious yellow dye, transfer to the city hospital treatment, diagnosed as "acute liver failure; jaundice," Two days later transferred to provincial Children's hospital treatment, and two days later treatment invalid death. Earlier, there have been media disclosures, Liaoning Sun Chao its 4-year-old daughter in Liaoning Province, the hospital was diagnosed with myasthenia gravis, suspected with the fever drug nimesulide. Guangdong Satellite TV has also reported that a child in Guangdong because of a fever to take the local hospital opened the nimesulide, liver poisoning, has been transferred to Guangzhou for medical treatment.　　In the patient's statement of the nimesulide, the adverse reaction indicated that "the drug has the risk of liver damage, but there is no relevant cases reported in the country." Many professional papers and local media have confirmed the domestic adverse reaction cases of nimesulide, in fact, after CCTV warning, Shanxi ADR Monitoring Center related to the local media confirmed that from 2004 to date, the center has received a total of antipyretic and analgesic drug adverse reactions reported as many as 3,300 cases, Many cases of adverse reactions involved children. Among them, the children with the focus of acetaminophen drug nimesulide occurred in 86 cases, the dosage form is mainly tablets and granules. But the reporter was not able to find similar information on the National ADR Monitoring Center website and could not find the relevant reports.　　and the center's phone has been unanswered.　　Canchi The main business of the pharmaceutical industry is obviously, if the above mentioned adverse reactions, or even fatal cases caused by the attention of the whole society, with Rui Zhi clear nimesulide granules as the main business of Canchi pharmaceutical industry will be greatly impacted. The report shows that Rui Zhi Qing 2007 years, 2008, 2009 sales of gross profit accounted for the same period of Canchi pharmaceutical sales of gross profit ratio of 72.89%, 84.67% and 89.54% respectively.　　"The production and sales status of Rui Zhi Qing basically determines the company's profitability and profitability," Canchi said in a prospectus. In the second half of 2010, after the successful expansion of Canchi pharmaceutical industry, the production capacity of its granules has been increased to 1.8 billion bags per year from 300 million bags, capacity expansion 6 times times, the current new capacity has been achieved scale production. Canchi drug industry director told reporters that the winter is the company Rui Zhi Qing sales peak season, the company's 3-quarter sales better than in the first half, and the 4-quarter situation is better than the 3 quarter.　　The company currently Indina, basically no stock. Obviously, CCTV's early warning to Canchi pharmaceutical industry Rui Zhi Qing's sales influence is limited. A brokerage researcher who has researched the Canchi pharmaceutical industry said to reporters, "because Canchi medicine Rui Zhi is to go to county-level, rural market-oriented third terminal sales, because the information asymmetry, many places can not watch CCTV news channels, there is no way to know the adverse reaction of nimesulide, the natural impact on its limited. The researcher stressed that "unless there is a concentration of adverse reactions, or adverse reactions to the social concern gradually, the Canchi pharmaceutical industry in the case of other drugs is not mature, will likely suffer a greater blow." And if the nimesulide, like abroad, is suspended, then, under the current share price or will be the Canchi pharmaceutical industry causedDevastating blow. ”