Drug regulatory bureau revises the national standard of valsartan, a high blood pressure drug substance, with toxic substances no more than 3 / 10 million

[policies and regulations of chinapharma.com] in early July, a pharmaceutical company announced that in the process of optimizing and evaluating the production process of valsartan API, it found and identified a kind of impurity containing genotoxicity -- nitrosodimethylamine (NDMA), with a very small content After finding out the situation, the pharmaceutical company immediately informed relevant customers and regulatory agencies, and recalled relevant products The author has learned that valsartan is an antihypertensive drug of angiotension II receptor antagonist, which mainly plays the role of vasodilation and lowering blood pressure In the United States, valsartan is a drug used to treat hypertension, congestive heart failure and post myocardial infarction In China, it is mainly used for mild to moderate primary hypertension, especially for secondary hypertension caused by kidney damage NDMA, also known as dimethylnitrosamine, is a very dangerous carcinogen to animals After the incident, the society and relevant regulatory departments have attached great importance to it On August 20, the State Food and Drug Administration publicized the revised version of valsartan national standard issued by the State Pharmacopoeia Commission, and updated the production requirements of valsartan: the production process must be evaluated to determine the possibility of NDMA formation If necessary, the production process shall be verified to show that the content of NDMA in the finished product meets the requirements The limit should not exceed three tens of millions For drugs, rigorous pharmaceutical production process is an important condition for quality assurance and safety assurance According to the industry, each link of drug development and production is closely related, and changes in one aspect of production process may have a comprehensive impact on drug safety, effectiveness and quality controllability When the results of in vitro study can not accurately determine the impact of changes on the product, further in-depth study and comprehensive evaluation of the impact of production process changes on drug safety, effectiveness and quality controllability are needed So, how to judge whether the antihypertensive drugs contain the problem "valsartan" for the patients taking the drugs? Technical personnel of a pharmaceutical company said that they could first contact the pharmaceutical company to inquire about the source of the drug and whether it was included in the recall return refund At present, the pharmaceutical companies with problems have decided to join hands with domestic customers for recall On the premise that the announcement has been made, the downstream pharmaceutical companies should hold the recall plan It is difficult for patients to identify the drug safety, so they can consult the pharmaceutical companies by phone Patients who are afraid of using related products may consider "changing the door" to use drugs from other manufacturers, but the doctor's order shall prevail Some patients are also worried about what to do if they have already taken some antihypertensive drugs containing the trace toxin? According to the person in charge, if the daily intake of genotoxic impurities is controlled within 1.5 micrograms, even if it is safe, the risk of taking large doses will increase sharply However, at present, valsartan of the problematic drug company still measures a small amount If the patient does not take it for a long time, they need not worry too much In addition, a spokesman of the State Food and Drug Administration reminded that patients taking valsartan drugs must not stop taking the drugs without permission The blood pressure can rise significantly in a short period of time, or even exceed the level before treatment, resulting in high blood pressure crisis symptoms such as dizziness, headache, blurred vision, etc If the drug is stopped or changed, it must be carried out under the guidance of the doctor You can contact the doctor to replace other drugs containing valsartan that do not involve the recall or choose other drugs for alternative treatment.