Class 2A carcinogen was detected in the drug! The problem valsartan API has been recalled.
Cctv news: Pay attention to the situation of valsartan in Zhejiang Huahai Pharmaceutical Company. Yesterday (July 29th), the spokesperson of National Medical Products Administration introduced the situation of trace N- nitrosodimethylamine (NDMA) impurities detected in valsartan raw materials of Zhejiang Huahai Pharmaceutical Co., Ltd.
On July 6th, Zhejiang Huahai Pharmaceutical reported to National Medical Products Administration that a small amount of N- nitrosodimethylamine (NDMA) impurities were detected in the raw materials of valsartan for export, and voluntarily disclosed relevant information to the public according to relevant regulations and requirements.
Zhejiang Huahai Pharmaceutical Co., Ltd. immediately suspended the release and delivery of all valsartan raw materials in the domestic and international markets after detecting the impurity, and initiated the measures of voluntary recall. As of July 23, Zhejiang Huahai Pharmaceutical has completed the recall of all raw materials in China.
In 2012 and 2013, the current process of raw materials of this enterprise was approved by the European Drug Administration (EMA) and the US Food and Drug Administration (FDA) respectively.
Since July 6th, National Medical Products Administration has maintained close communication and contact with the European Drug Administration and the US Food and Drug Administration, paid close attention to the announcements and trends of risk assessment issued by international regulatory agencies, and organized experts to carry out risk assessment.
According to the toxicological data, the maximum daily intake limit of N- nitrosodimethylamine is 0.1μ G, which is equivalent to the provisional reference limit value of 0.3ppm by the European Drug Administration (calculated by taking 320mg valsartan daily).
According to the above-mentioned limit value, National Medical Products Administration conducted risk investigation on all the seven domestic manufacturers of valsartan raw materials (including Zhejiang Huahai Pharmaceutical). Except for the impurity of N- nitrosodimethylamine in valsartan raw materials of Zhejiang Huahai Pharmaceutical, the impurity detection value of N- nitrosodimethylamine in other domestic manufacturers of valsartan raw materials was lower than the limit value or was not detected.
There are 6 pharmaceutical manufacturers involved in the use of valsartan in Zhejiang Huahai Pharmaceutical:
The valsartan capsule (National Medicine Zhunzi H20103521) produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. has not yet left the factory.
The impurities of N- nitrosodimethylamine in the listed products of the other five manufacturers exceeded the limit, namely
Valsartan Hydrochlorothiazide Capsule of Chongqing Kangkeer Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20080097)
Valsartan dispersible tablets of Hainan Huanglong Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20050508)
Valsartan dispersible tablets of Harbin Sanlian Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20061058)
Valsartan Hydrochlorothiazide Dispersible Tablets of Jiangsu Wangao Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20090262)
Valsartan dispersible tablets of Shandong Yijian Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20090319)
The above five preparation manufacturers have stopped using the raw materials of Valsartan of Huahai Pharmaceutical and recalled relevant drugs according to regulations.
National Medical Products Administration has asked all provincial food and drug supervision and management departments to urge relevant preparation manufacturers to take recall measures, and disclose relevant recall information on the websites of five manufacturers, including the contact numbers of the enterprises responsible for the recall.
In order to facilitate the public to know in time whether the Valsartan drugs being used are within the scope of recall, five manufacturers have cooperated with information technology companies and launched the code scanning inquiry function at 22: 00 on July 26, 2018. The product traceability code can be scanned through the mobile APP to realize instant inquiry.
National Medical Products Administration spokesman stressed that besides the above five preparation manufacturers, other valsartan preparation products are not included in the recall.
At present, European Union and other multinational drug regulatory agencies believe that N- nitrosodimethylamine belongs to Class 2A carcinogen (that is, there is sufficient evidence in animal experiments, but the evidence is limited), and it may be exposed to this substance in daily life (such as preserved food). Analysis of the drugs involved this time will not cause serious health risks to patients, but for safety reasons, risk control measures such as stopping sales and recalling should be taken.
On July 27th, FDA issued a notice that patients taking recalled valsartan should continue to take the current drugs until doctors or pharmacists provide alternative drugs or different treatment schemes.
A spokesman for National Medical Products Administration reminded that patients who are taking valsartan drugs must not stop taking them without authorization, because the risk of stopping taking them without authorization is more direct and serious for patients with hypertension. Whether to stop taking medicine or change medicine must be carried out under the guidance of a doctor. You can contact a doctor to replace other drugs containing valsartan that are not involved in the recall or choose other drugs for alternative treatment.
National Medical Products Administration requires the relevant provincial food and drug supervision and management departments to continue to follow the relevant provisions of the Measures for the Administration of Drug Recall, urge enterprises to do a good job in product recall and protect people’s drug safety.