One valsartan tablet with a little liquid is a typical morning hypertension. According to the Ministry of Health, valsartan is the seventh most prescribed drug for high blood pressure. The medication protects against stroke or heart problems, and also prolongs the life of hypertensive patients. In 2018, a substance capable of causing cancer was discovered in products with valsartan.
What substance was found in preparations with valsartan?
In August 2018, Germany retired valsartan from 17 pharmaceutical manufacturers. Laboratory studies have revealed a high level of toxic substances to health. If this suspicion is confirmed, Europe may face one of the largest pharmaceutical scandals in recent years.
It all started with the Chinese company Zhejiang Huahai Pharmaceutical, which supplies most of valsartan to Europe and Russia.
A Spanish pharmaceutical manufacturer asked to study a medicine with valsartan from Zhejiang Huahai Pharmaceutical. From there, the information was sent to the Federal Administration for Medicines and Medical Devices (BfArM). At this time, it was already clear that preparations containing valsartan contained a horse dose of N-nitrosodimethylamine (NDMA).
What is NDMA and why is it dangerous?
NDMA is nitrosamine found in canned meat or fish products, as well as in alcoholic products. Many nitrosamines are chemicals that alter the human genome.
Adverse effects on cells have been proven only in studies on rabbits and mice.
However, the chemical compound is so carcinogenic that there is no threshold below which it is harmless.
Official agencies are still studying the composition of drugs containing valsartan. According to BfArM spokesman Mike Pommer, the evaluation process for Ema is still ongoing. How long the investigation will continue depends on the cooperation of pharmaceutical manufacturers and government agencies in China.
In tablets, up to 0.2 mg of NDMA was detected. Scientists explain that this is a relatively high dose.
Russians take an average of 0.2-0.4 micrograms of nitrosamines with food per day. One valsartan tablet may contain 80 times more NDMA than the average European or Russian consumes.
1 kilogram of smoked ham contains 3 micrograms of nitrosamine, which is only 1/10 of what was found in some tablets.
When smoking a cigarette, about 40-50 nanograms of nitrosamine are formed, which is 1/1000.
Are there any risks for patients from Russia?
Valsartan from Chinese manufacturers is also supplied to the Russian Federation, so there is a risk for the Russians.
The real problem is Russia's great dependence on China when it comes to drugs.
Russian doctors doubt the quality and, above all, the safety control of drugs. They hope that pharmaceutical manufacturers will learn from mistakes.
Do not stop taking drugs!
Doctors recommend that you do not stop taking medications until the results of the study of products with valsartan are announced. The degree of cancer risk from NDMA is still not fully understood. The carcinogenic effect was confirmed only in animal experiments. According to FDA experts, of the 8,000 patients who took valsartan for 4 years (320 mg per day), 1 got cancer.
If in doubt, it is better to talk with a pharmacist or ask your local GP for another medicine.
Valsartan approved drugs in Russia may be withdrawn from the pharmaceutical market in 2019.
The European Medicines Quality Authority (EDQM) and national regulatory authorities have begun testing other medicines.
There are about 40 suppliers of valsartan in the world — most in India, China, Japan, and some in Mexico and Italy.
Further research will show which firms also neglected the safety and quality guidelines.
