Valsartan, containing a carcinogen, has been recalled. Is your blood pressure medication safe?
Published Time:
2018-07-27
The recent discovery of toxic impurities in valsartan, a raw material for antihypertensive drugs, has sparked ongoing public concern.
Recently, the European Medicines Agency (EMA) issued an announcement stating that valsartan raw materials produced by a Chinese pharmaceutical company were found to contain N-nitrosodimethylamine (NDMA), a carcinogenic impurity. The EMA has decided to conduct an assessment and investigation of the raw material and has requested a recall of valsartan preparations produced using this raw material.
As the incident continues to escalate, recalls are underway both overseas and domestically! Huahai Pharmaceutical, the company involved, announced that the impurity is an inherent impurity generated during the production process, with extremely low levels, but it was found to be genotoxic. Yesterday, Huahai Pharmaceutical issued another announcement stating that it has jointly decided with its domestic clients to proactively recall valsartan preparations marketed domestically that were produced using Huahai Pharmaceutical's valsartan raw materials.
"Does my blood pressure medication contain toxic valsartan?" For patients without the ability to identify this, it is recommended to contact the pharmaceutical company to inquire about the source of their medication or follow their doctor's advice to switch to another medication.
Huahai Pharmaceutical Recalls Valsartan-Containing Antihypertensive Drugs in China
Recently, Huahai Pharmaceutical conducted recalls in the European and US markets. In addition, Japan is also recalling preparations containing valsartan raw materials supplied by Huahai Pharmaceutical.
Yesterday, Huahai Pharmaceutical issued an announcement that it is simultaneously recalling products domestically. The announcement stated that given the discovery of trace amounts of genotoxic impurities (NDMA) in the unknown impurities of the company's valsartan raw materials, and after testing revealed the presence of NDMA impurities in the company's domestically sold valsartan raw materials, the company decided to proactively recall valsartan raw materials marketed domestically and internationally as a risk prevention measure. The company has also informed domestic clients using Huahai Pharmaceutical's valsartan raw materials, urging them to fully assess the risks of NDMA and promptly develop corresponding risk control plans. The company stated that it will implement the recall in accordance with the requirements of the national "Drug Recall Management Measures".
Downstream pharmaceutical companies had already taken action earlier. On the evening of the 15th, Harbin Sanlian Pharmaceutical, which uses Huahai Pharmaceutical's valsartan raw materials, issued an announcement stating that it had decided to proactively recall valsartan dispersible tablets produced using Huahai Pharmaceutical's valsartan raw materials, but because it does not solely use Huahai's raw materials, finished products not using Huahai's raw materials will not be recalled.
Harbin Sanlian also stated its intention to seek compensation, saying that it has the right to take corresponding legal measures in accordance with relevant laws, regulations, and contract agreements due to economic losses caused by the supplier, including the scrapping of relevant inventory and product recalls.
Other Pharmaceutical Companies Supplying Valsartan Have Not Found Any Problems
What exactly is valsartan? Wang Jiansong, Vice President of Technology at Baiyunshan Pharmaceutical Factory, introduced that valsartan is a mainstream antihypertensive drug, a classic drug that has been on the market for many years, and no particularly unusual adverse reactions have been found. Valsartan can inhibit vasoconstriction and aldosterone release, thereby producing an antihypertensive effect. The main raw material of this drug is valsartan compound (also known as ambroxol hydrochloride impurity D), which is a white crystal or white powder, hygroscopic but insoluble in water. This drug is mainly in capsule form, with the characteristics of long-lasting and stable blood pressure lowering effect and low side effects, so it is widely used.
Currently, other companies in China hold 10 production approval numbers for domestically produced valsartan raw materials. In terms of preparations, there are 6 approval numbers for valsartan tablets, 13 for capsules, and 6 for dispersible tablets. Apart from Huahai Pharmaceutical, no similar problems have been reported for valsartan raw materials supplied by other pharmaceutical companies.
"This drug has a very wide range of indications and can be used for various types of hypertension, and it has a good protective effect on the heart, brain, and kidneys. It can be used routinely for hypertensive patients with myocardial infarction, heart failure, proteinuria, and diabetes, and can be used in combination with diuretics. This includes antihypertension, mild to moderate primary hypertension, especially in patients with secondary hypertension caused by kidney damage." said Wang Jiansong.
Some pharmaceutical companies have proactively declared that their antihypertensive drugs do not use raw materials from Huahai Pharmaceutical to reassure patients. Qianjin Pharmaceutical, a listed pharmaceutical company, stated that its valsartan capsules do not use raw materials from Huahai Pharmaceutical.
Focus
The problematic valsartan incident continues to ferment, causing concern among hypertensive patients who take antihypertensive drugs daily. "Is the blood pressure medication I'm taking valsartan?" "Can valsartan still be taken? "
What is the impurity in the problematic valsartan?
Valsartan belongs to the angiotensin II receptor blocker. "Angiotensin II" causes the constriction of small arteries throughout the body, leading to increased blood pressure. It also reduces the excretion of sodium and water by the kidneys through a series of actions, leading to an increase in total blood volume, further exacerbating high blood pressure. Valsartan can counteract "angiotensin II", thus controlling blood pressure.
In addition to its direct blood pressure control effect, valsartan can also provide long-term protection for important organs such as the heart, brain vessels, and kidneys. Therefore, it can be used not only alone but also in combination with antihypertensive drugs with different mechanisms of action. Valsartan can be found in many antihypertensive drug formulations.
According to the announcement issued by the European Medicines Agency, the generic valsartan produced by Huahai Pharmaceutical was found to contain an impurity called "N-nitrosodimethylamine" (NDMA). On October 27, 2017, NDMA was classified as a Group 2A carcinogen in the list of carcinogens published by the International Agency for Research on Cancer of the World Health Organization. According to data from animal experiments in relevant scientific literature, this impurity is genotoxic.
According to Huahai Pharmaceutical's announcement, the NDMA detected in its valsartan is an inherent impurity generated in the valsartan production process it employs.
How to determine if a blood pressure medication has problematic valsartan?
How can hypertensive patients determine if their blood pressure medication contains problematic valsartan?
"Those who have blood pressure medication and have concerns can temporarily stop taking it and contact the pharmaceutical company in the next couple of days to inquire about the source of the medication and whether it is subject to recall, return, and refund." A technical manager from a pharmaceutical company in Guangzhou told reporters that since Huahai Pharmaceutical has decided to jointly recall products with its domestic clients, and given that the announcement has been made, downstream pharmaceutical companies should have recall plans in place. Patients themselves have difficulty discerning the safety of the medication and can contact the pharmaceutical company by phone. Patients who are afraid of using the affected products can consider switching to products from other manufacturers, but this should be done under the guidance of a doctor.
What if someone has already taken some of the antihypertensive drug containing this trace toxin? In response, the person in charge stated that it is considered safe for a person to ingest up to 1.5 micrograms of genotoxic impurities per day. Large doses would certainly increase the risk, but the amount of valsartan detected in Huahai's product was still trace, and the patient did not take it long-term, so there is no need to worry too much. The harm to human health may not necessarily occur; it's just a matter of being cautious and preventing problems before they arise.
Editor: Xu Zhiqiang
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