Compile: Sai Baila / small beautiful
NDMA disturbance is not smooth, FDA and EMA are checked again gave new foreign matter.
▍ new impurity is monitored to go out, FDA and EMA all issue relevant statement
Recently (on September 13) , FDA announced his to concern the up to date information that product of Xie Sha Tan investigates continuously, and make clear, a company already discovered other foreign matter in the product of recall (NDEA) .
Same day, EMA (management board of European medicines and chemical reagents) released the newest case that about Xie Sha Tan medicaments investigates, the announcement makes clear, the cancer risk that EMA replaced the remedy of Xie Sha Tan that contains NDMA is calculated, the risk evaluates make clear: The risk of NDMA is very low, its are relevant content qualitative N- inferior 2 ethylamine of nitro- (NDEA) in also be being investigated.
In the announcement that issues in FDA, its are newest product test makes clear as a result: Additional impurity exists in the product of medicaments of Xie Sha Tan that has recall of company of pharmacy of 3 batches of Torrent. This impurity N- inferior nitro- 2 ethylamine (NDEA) it is foregone animal and doubtful human carcinogen.
FDA and understanding of management board of European medicines and chemical reagents arrive, industry of drug of Zhejiang China sea (ZHP) NDEA discovered in API of Sha Tan of a few batches of Xie. Because of NDEA, FDA begins to test API of all Xie Sha Tan and product afresh instantly, the product that includes recall and still be in at present the product of the sale. According to FDA up to now detect, the orgnaization discovered NDEA in the API of Sha Tan of a few Xie in ZHP. In the meantime, the 160mg of Xie Sha Tan in Torrent (batch BV47D001) with 320mg (batch BV48D001 and BV48D002) this kind of impurity also discovered in tablet, these tablet use the API preparation that comes from ZHP. The test of FDA makes clear, the product that is not API of Sha Tan of Xie of all use ZHP to make contains NDEA impurity.
The director Scott Gottlieb of FDA expresses: "We will continue to consider to the prime cause of foreign matter appears in product of Xie Sha Tan, scientists are testing these products, with knowing these foreign matter better, ensure they are nonexistent in other product. We still will adopt measure to ensure to workmanship supervise strictly, be introduced in order to reduce foreign matter the possibility of other product. Be introduced in order to reduce foreign matter the possibility of other product..
Scott Gottlieb acceptance: FDA will continue the fact updates findings, continue to superintend orgnaization collaboration with the whole world, understand the reason that these impurity produce as far as possible, and the effect that they cause to the healthy state of global patient.
FDA is continueing to check other the product that contains Xie Sha Tan, in order to decide whether they contain NDEA. If FDA is in not by the discovery in the product of recall NDEA, orgnaization general and company cooperate, ensure all products that get an effect move from the market except. In the meantime, FDA still is in the NDEA in evaluating these products is right the patient's risk. FDA hope finishs this risk a few days to analyse in future, will continue to offer follow-up progress to the public after new information is announced.
FDA announcement shows, like NDMA, NDEA also is formed by specific technology measure and chemical reaction. FDA future still will issue the preliminary method of the NDEA that monitor. Manufacturer and whole world superintend an orgnaization to be able to use this kind of method to choose other product to whether be put in this kind of impurity.
EMA also announced similar news: EMA is assessing the impact of NDEA, this material has been in the Xie Sha Tan that before Zhejiang China sea changed technology 2012, produces check goes out, NDEA and NDMA all are belonged to inferior saltpetre amine, the human carcinogenic substance of the likelihood that be labelled.
▍ is in critical research, the risk causing cancer of NDMA is relatively inferior
On August 30, director FDA Scott Gottlieb, medicaments is evaluated and Janet Woodcock of research center director, issue the statement that product of relevant Xie Sha Tan checks.
Express in statement: FDA is having a major move at present, with investigate and solving this one disturb discovery. This investigation is led by special expert working group, their task is to supervise investigation to dog the new development of manufacturer of Xie Sha Tan and information. This by chemist, home of poisonous a Confucian school of idealist philosophy of the Song and Ming Dynasties, doctor, apothecary, researcher, communication expert and the much discipline group that analyse composition of lab staff member will coordinate whole FDA, take action according to newest information.
Home of poisonous a Confucian school of idealist philosophy of the Song and Ming Dynasties and chemist evaluated NDMA the risk to the public: They predict, if everyday 8000 people take the remedy of Xie sanded calm that contains NDMA, and take is highest dosage (320mg) , last 4 years, the likelihood is met only many one exemple cancer.
Besides be being investigated, FDA still will continue to announce relevant news in real time, detailed and listed all recall and not the detailed list of product of Xie Sha Tan of recall, will offer a proposal for patient and doctor.
On September 13, the venture that EMA also announced his to concern NDMA beforehand appraise research: The risk that the NMDA of this kind of level causes cancer is considered as very low, if the patient arrives from July 2012 between July 2018 daily by highest dosage (320 Mg) take Xie Sha Tan, reckon rate contracting cancer is 1/5, 000. This kind of assessment foundation is hypothesis NMDA is contained in the product since Hua Hai changed technology 2012 oneself, in assuming all NDMA transfer end item.
