Trodzumab has been accused of concealing adverse reactions, or causing heart disease, stroke!

Source: torzhumab, a drug used to treat rheumatoid arthritis under Roche, a Swiss pharmaceutical giant, has attracted much attention recently According to foreign media reports recently, Roche's topiramab may cause adverse reactions such as heart disease and stroke The drug is also said to be related to the death of hundreds of patients, but the drug specification does not indicate these adverse reactions Roche responded that the results of the post marketing investigation will be reported to global health departments including the U.S Food and drug administration, and the current data do not support the listing of these events in the specification It is understood that the drug has been on the market in China for more than 3 years, with the Chinese name of yamelo The reporter confirmed to the clinician that due to the limited indications of the drug and other reasons, the accumulation of domestic cases is not much, and no obvious side effects have been found According to stat news, which focuses on technology and health news related to hundreds of deaths of patients, trodzumab is said to be related to hundreds of deaths due to no side effects of drugs Hundreds of patients who took the drug died of cardiopulmonary complications, the survey found It should be noted that, unlike competitive drugs, topiramab does not remind of possible side effects Torzhumab is the first new drug for the treatment of Anti-IL-6 receptor At present, it is approved to be used in rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis in the United States Approved in 2010, the drug has been used in more than 760000 patients and contributed $1.7 billion to Roche's revenue last year The report analyzed and investigated more than 500000 reports of adverse reactions after taking the drug, saying it found "conclusive evidence" - the risk of side effects in patients taking topiramab was at the same level or even higher than that in patients taking competing drugs, including heart disease and stroke Eric, deputy director of drug label development group, FDA Dr Brodsky said in an interview that there are still some problems in determining the cause of adverse reactions through the data provided by the adverse event reporting system, including inaccuracy, concurrent diseases and possible side effects caused by patients taking other drugs The report "shows the correlation between the two, but not the causal relationship." According to the report, the US Food and drug administration has received the death report of 1128 patients after taking topiramab, but due to the lack of "precision tools", it has not been determined whether taking the drug is the direct cause of death Nevertheless, the media quoted several doctors as saying that the drug played an important role in the death of patients, and there was a certain connection between the two, but the identity information of doctors was not disclosed In addition, some experts, who declined to be named, told the media that they suggested that the FDA must consider adding warning labels for heart failure and pancreatitis to the drug The FDA has not yet responded to the report Roche said in an interview that after the drug was approved for marketing, Roche's investigation results on adverse drug reactions will also be released every six months and reported to the global health sector, including the FDA The current data does not support listing these events in the specification In November 2013, Roche announced that tosubzumab was officially launched in China with the Chinese name of yamero Thanks to the domestic policy of encouraging the development and application of children's drugs, yamero has added the indication of "systemic juvenile idiopathic arthritis" Systemic juvenile idiopathic arthritis is a kind of autoimmune disease, which is the most serious subtype of juvenile idiopathic arthritis It seriously affects the growth and development of children, with high disability rate and mortality The disease usually occurs before the age of 16, the peak of which is 5-7 years old At present, there are about 15000 children with systemic juvenile idiopathic arthritis in China Due to the lack of biological agents that have been widely used abroad, NSAIDs and hormone drugs are the main medical means adopted in China at present, but long-term use of hormones will cause many adverse consequences for children, such as slow growth and development, obesity, hypertension, osteoporosis, gastrointestinal bleeding, diabetes and so on Yamelo is the only approved biological agent for the treatment of this disease in China, which means 15000 children have the right medicine According to the information on the official website of the State Food and drug administration, there are three dosage forms of yamelo currently used in China The drug manual warns that there is a risk of serious infection, which may cause adverse reactions such as upper respiratory tract infection and gastritis, excluding the risk of heart disease and stroke According to Roche, there have been more than 20000 clinical studies of yamelo and more than 10000 patients in China, maintaining a good benefit risk ratio As for drug safety, the mid-term data of the multi center noninterventive study on the treatment of rheumatoid arthritis (RA) by yamelor in China published in May this year showed that among the 194 patients who received yamelor treatment, there was 1 adverse event of heart damage, 1 patient stopped using yamelor due to adverse event, and there was no death in the course of medication According to the monitoring of the safety data since the approval of yamelo for marketing, the safety situation is consistent with the safety characteristics of toluzumab in yamelo's Chinese specification Zhang Xuewu, chief physician of Rheumatology and Immunology Department of Peking University People's Hospital, told reporters that yamelo is a relatively late listed biological preparation in China, and its mechanism is also different from other similar products, with different drug targets "Due to limited indications, clinical use is relatively small, and case accumulation is not much." At present, no obvious side effects have been found in the clinic "We haven't encountered any adverse reactions in the heart." Zhang Xuewu said ■ extension: it is not the first time that Roche is suspected of concealing reports in 2012 Roche has been involved in the scandal of concealing reports The British drug and health products administration found that Roche concealed 15000 reports of deaths and 65000 adverse reactions during routine inspection of the drug safety alert system of Roche pharmaceutical headquarters Roche later confirmed that the drugs involved in the "potential adverse events not reported in time" were 8 drugs, including topiramab, Avastin, Herceptin, raptiva, ateplase, rapaxine, meropene and trocaine Six of the drugs were then sold in China Roche also said the situation has been reported to China's State Food and drug administration According to the State Food and drug administration at that time, no abnormal report has been found in the ADR monitoring of the drugs involved in the incident.