Patient Q&A regarding Valsartan-Hydrochlorothiazide Dispersible Tablets
Published Time:
2018-07-25
Company Anmingsong strictly follows the requirements of the "Good Manufacturing Practice for Pharmaceutical Products" (2010 edition) in its production. Huahai Pharmaceutical is one of the company's three valsartan raw material suppliers. The valsartan raw materials purchased from Huahai Pharmaceutical are subject to comprehensive inspection according to the YBH01882012 standard provided by Huahai Pharmaceutical and the 2015 edition of the Chinese Pharmacopoeia, Part II. Only after meeting the original statutory standards are they released for production.
Q&A regarding patients using Anmingsong (valsartan hydrochlorothiazide dispersible tablets)
1. Can I return or exchange the product?
Returns and exchanges are absolutely possible. Our company has three qualified valsartan raw material suppliers. First, you need to contact our company to confirm whether your Anmingsong was produced using valsartan raw materials from Huahai Pharmaceutical. If so, you can return it to our company for a return or exchange. Please use a prepaid shipping method to send it to our company.
2. Does Anmingsong have quality issues?
Anmingsong is produced in strict accordance with the "Good Manufacturing Practice for Drugs" (2010 edition). Huahai Pharmaceutical is one of our three valsartan raw material suppliers. The valsartan raw materials purchased from Huahai Pharmaceutical are subject to comprehensive testing according to the standards provided by Huahai Pharmaceutical (YBH01882012) and the 2015 edition of the Chinese Pharmacopoeia, Part II. Only after meeting the original statutory standards are they released for production.
The recent NDMA issue mainly involved the unexpected discovery of trace amounts of impurities in valsartan raw materials sold by Huahai to overseas markets. This impurity is actually widely present in everyday food, beverages, tobacco, rubber products, and even air, water, and soil. Beer, smoked foods, fish, food processing plants, and cosmetics factories are also major potential sources.
All our products meet national quality standards and have no quality problems. Previously, our country, the United States, and the European Union did not test for or control this impurity in valsartan. Following this incident, we have added this test to Anmingsong's internal control standards. Every batch of newly produced products is entrusted to the Changzhou Food and Drug Supervision and Testing Center for NDMA testing before being released for sale. Please rest assured.
3. Is this NDMA impurity carcinogenic as reported online?
The International Agency for Research on Cancer (IARC), a specialized agency of the World Health Organization, classifies carcinogenic substances. According to information on the IARC website, Group 1 carcinogens are substances that are definitively carcinogenic, including smoking, secondhand smoke, and salted fish (Chinese style). NDMA is classified as a Group 2A carcinogen. Group 2A carcinogens are substances for which there is supporting data from high-dose animal experiments, but no conclusive evidence of carcinogenicity in humans. Other substances in Group 2A include hot drinks above 65 degrees Celsius, red meat, and shift work with disrupted circadian rhythms. To date, international research on the carcinogenicity of NDMA is limited to animal experiments, and there is no human data indicating definite carcinogenicity in humans. Therefore, the International Cancer Research Institute classifies this substance as a probable carcinogen.
4. I have been using Anmingsong for a while. Should I stop taking it?
Announcements from Germany and the European Medicines Agency (EMA) mention that this recall is based on risk prevention and responsibility towards patients to minimize risks. Unless your doctor advises you to stop taking it, it is recommended that you do not discontinue treatment. If you experience any adverse reactions or have any questions, please consult your doctor before making a decision.
Anmingsong is a very effective antihypertensive drug with good safety and rare side effects. It is recommended by numerous international and domestic hypertension guidelines and is currently a mainstream product for antihypertensive treatment. If impurity testing confirms that the content is within the newly established national standards, it is recommended not to change medications easily.
First, you should not suddenly stop taking the medication. Patients who have been taking antihypertensive drugs for a long time may experience rebound hypertension and withdrawal syndrome if they suddenly stop taking the medication. This is mainly manifested as a sudden increase in blood pressure, headache, dizziness, fatigue, etc. Sometimes, a sudden increase in blood pressure can lead to cerebrovascular accidents. This is because long-term medication leads to the body's dependence on the drug, and sudden cessation can cause a reflex reaction; second, do not take medication indiscriminately. There are many types of antihypertensive drugs, with different sites of action, effects, side effects, indications, and contraindications. Therefore, it is best not to use or change medications on your own. Any adjustments to medication should be made under the guidance of a doctor.
5. For Anmingsong that our company is recalling, if you wish to exchange or return it, all costs will be borne by our company. We have opened a dedicated hotline with a dedicated person in charge of this matter. As long as you confirm the quantity of Anmingsong you have, we will immediately express deliver the latest batch of products that have passed the NDMA special test to you. You can send the old product back after receiving the new one.
Company hotline: 0513-82116300 82190509 82190521.
Company contact email: wangaoyaoye@wangao.com.cn
Contact address: No. 688, Dinghai Road, Haimen Economic and Technological Development Zone, Jiangsu Province, Jiangsu Wangao Pharmaceutical Co., Ltd., Shen Lingling (recipient), 0513-82190509, Postcode: 226100
Attachment
Introduction to N-Nitrosodimethylamine Impurities
According to news reports interviewing a former senior pharmacotoxicology reviewer from the US FDA regarding the valsartan impurity incident, the trace amounts of N-Nitrosodimethylamine (NDMA) found in valsartan raw materials are actually widely present in everyday food, beverages, tobacco, rubber products, and even air, water, and soil. Beer, smoked foods, fish, food processing plants, and cosmetics factories are also major potential sources.
The International Agency for Research on Cancer (IARC), a specialized agency of the World Health Organization, classifies carcinogenic substances. According to information on the IARC website, Group 1 carcinogens are substances that are definitively carcinogenic, including smoking, secondhand smoke, and salted fish (Chinese style). NDMA is classified as a Group 2A carcinogen. Group 2A carcinogens are substances for which there is supporting data from high-dose animal experiments, but no conclusive evidence of carcinogenicity in humans. Other substances in Group 2A include hot drinks above 65 degrees Celsius, red meat, and shift work with disrupted circadian rhythms. To date, international research on the carcinogenicity of NDMA is limited to animal experiments, and there is no human data indicating definite carcinogenicity in humans. Therefore, the International Cancer Research Institute classifies this substance as a probable carcinogen. Also, tumor development in rodents is influenced by both dose and time.
Announcements from Germany and the European Medicines Agency (EMA) mention that while further assessment is needed, there is no acute patient risk, and patients should not be overly concerned. This recall is based on risk prevention and responsibility towards patients to minimize risks. Unless your doctor advises you to stop taking it, it is recommended that you do not discontinue treatment. If you experience any adverse reactions or have any questions, please consult your doctor before making a decision.
References on Overseas Recalls
1. The EU's progress announcement on valsartan impurities states:
While further assessment is needed, there is no immediate risk, and patients taking valsartan are advised not to stop their treatment unless advised to do so by their pharmacist or doctor. Healthcare professionals should follow specific advice from national authorities regarding medicines in their country.
Although further assessment is needed, there is no immediate risk. Patients taking valsartan are advised not to stop treatment unless instructed to do so by their pharmacist or doctor. Healthcare professionals should also follow the specific advice of national authorities regarding medications in their country.
2. The German official announcement states:
Patients taking medications containing valsartan should not stop taking them without consulting a doctor, as the risks of stopping are far greater than the potential risks associated with the impurity. There is no acute risk to patients.
3. International Agency for Research on Cancer classification of carcinogens:
https://www.cancer.org/cancer/cancer-causes/general-info/known-and-probable-human-carcinogens.html
4. According to an email from Novartis spokesperson Eric Althoff on July 6th: "The levels of NDMA found in the valsartan API are far below the cumulative endogenous levels and typical external exposures of this substance in the body." The extent to which this substance might increase the risk of cancer in humans is uncertain. Therefore, the amount of NDMA found in the valsartan API is not expected to significantly increase the risk for patients taking the medication.
Next Page
Next Page:
Recommended News
Email: marcos.yuan@wangao.com.cn
Address: No. 688, Dinghai Road, Haimen City, Jiangsu Province
Mobile Version QR Code
Whatsapp Account
Copyright © 2025 Jiangsu Wangao Pharmaceutical Co., Ltd.