Last time (August-September 2018), questions and consultations were often asked where the most popular among our citizens were preparations based on valsartan – Walz, Valsartan, including the combination of these drugs with the diuretic component hydrochlorothiazide.
At first, reliable information about this problem was not available even to the medical community until the European Medicines Agency (EMA) published its press release. It turns out that for most manufacturers, including those from Europe, the active substance or substance for the production of these drugs was produced at one Chinese factory by Zhejiang Huahai Pharmaceuticals (Linhai, China). The problem is that EMA research showed that a potentially dangerous impurity of N-nitrosodimethylamine (NDMA) was found in the substance of this factory. Most likely this was caused by a change in the production technology of valsartan in a Chinese factory, when particles of a potentially dangerous carcinogen began to fall into the finished mixture.
As a result, large batches of drugs had to be removed from sales and disposed of. The distribution included mainly product lines popular in Europe, and not in Russia, of the following companies: Generic Arrow, Biogaran, Cristers, EG Labo, Evolupharm, Ranbaxy generic pharmacy, Sandoz, Zentiva, Zydus. The Russian buyer of drugs based on valsartan will not find manufacturers in their names for these firms. This is more of a European problem. In France, doctors were advised to temporarily suspend the prescription of valsartan-based drugs to eliminate the deficiency and to write out analogues from other groups of antihypertensive drugs to lower high blood pressure.
Following ANSM (French National Agency for the Safety of Drugs) published information that the discovered defect does not put patients at acute risk. That is, the carcinogenic effect from the use of low-quality products can manifest itself only with the systematic and prolonged use of these drugs. Cancer from a single use of low-quality drugs quickly get sick. It seems that a person gets far more carcinogens with fried food than with a pill, and nothing continues to live and be healthy.
Why, then, did the drug Walz, which is produced by the Bulgarian company of Balkanpharm concern, disappear from the Russian market? At the moment there were no official statements from the company or domestic officials, but I think the reason is obvious. If, on a potentially more monetary and expensive European market, significant batches of drugs based on valsartan are removed from the sale and there is a shortage of these drugs, then this drug by the Bulgarian company is based on the principle of European solidarity and financial gain (short transport route to European consumers, solvent market) priority comes to the expensive European, not Russian market. So only market mechanisms intervened, not policies, sanctions and other possible causes.
I want to believe, as soon as the deficit in Europe is eliminated, the Chinese will start production of pure valsartan, without harmful impurities, the medicines that are familiar to the citizens of our country will return to the pharmacy counters.
Panic is canceled. In many pharmacies in Moscow, Walz has already appeared on the market, and in some it has not disappeared, and at a price no more expensive than it was before the Euro-Chinese panic with Valsartan.
I would like to believe drugs with low-quality valsartan will not appear later in our market under various, including domestic brands. In this regard, responsible officials of the Ministry of Health should keep their ears open and check more carefully the possible batches and substances for the production of medicines imported into the country. And for the first time I can advise consumers to pay attention to the appearance of their usual pills so that the labeling of such pills you are used to is not changed to the incomprehensible, which may indirectly serve as a fact of selling fake, let it be European fake based on discarded lots goods released from the Chinese hazardous substance. For the pharmaceutical market and dealers there are no preconceptions on it, we could be convinced of this many times, so consumers should not relax.
So summarize. The Chinese made a manufacturing defect by releasing a poor-quality substance based on valsartan onto the European market. The European regulator noticed this and banned the sale of medicines based on this component. There was a shortage that began to be eliminated by manufacturers using components of their own production or receiving components from places other than guilty manufacturers. The echo of this shortage affected the shipment of drugs based on valsartan to the Russian market, which caused our people to panic because of the lack of information from officials and manufacturers. I want to believe, the shortage will soon be eliminated and the medications familiar to our consumers will be returned to the shelves of pharmacies (somewhere this has already happened).
According to the State Register of Medicines of the Ministry of Health of Russia (
Valsakor – KRKA,
Although it is easier to list only one drug, which was produced in Russia on the basis of the substance of this Chinese company and according to the registry, it was Disartan, a combination drug based on amlodipine and valsartan, although according to the registry it is impossible to establish unequivocally that Zhejiang Huahai was the manufacturer of Valsartan, not any other. Yes, and I have not seen Disartan for a long time on sale. So, in principle, as was mentioned above, drugs with a carcinogenic component in valsartan did not fall into Russia, because the suppliers of these drugs are different.
List of withdrawn drugs