After the big recall in the summer, manufacturers still have blood pressure-lowering with Sartan drugs from the market. In the manufacture of a carcinogenic substance is created. Doctors warn, however, before the immediate Discontinuation of medication: A frenzied blood pressure is much more dangerous for the health.
In the summer of 2018, more than a dozen vendors had to call a lot of your blood pressure medication with the active ingredient Valsartan from wholesalers and pharmacies. Controls of the European medicines Agency (EMA) had shown that in the manufacture of Valsartan, the Chinese manufacturer Zhejiang Tianyu carcinogenic N-nitrosamines in the blood-pressure-lowering active ingredient. The recall of all affected batches was carried out Europe-wide.
Since then, individual smaller batches sartanhaltiger blood were called back pressure (also known as Angiotensin-II receptor blocker), because it contains risky amounts of N-nitroso dimethyl amine (NDMA) or N-nitroso diethyl amine (NDEA).
Again, the recall of high blood pressure
Finally, there were the blood pressure-lowering drug with the active ingredient Irbesartan or Losartan by Heumann. Even with these current recalls are individual smaller batches and not to order a recall of the product in all the dosages and pack sizes.
A list of all the from July 2018 to 19. February 2019 recalled high blood pressure medicine has selected the drug Commission of the German pharmacists. It is on the side of the Federal Union of German associations of Pharmacists (ABDA).
Manufacturing process to blame for the contamination
The risk of contamination has arisen, in all probability, by a change in the method of production of Sartans. The modification of the production took place without informing the European medicines Agency.
The cancer risk due to N-nitrosamines has been proven only in animal studies. The WHO classifies the substances but as the possible cancer risk to humans. The FDA has concluded in a theoretical calculation based on an additional cancer case in 8000 patients, if these four years, the maximum dose of 320 milligrams daily to contaminated valsartan-containing blood pressure.
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Sudden withdrawal is more risky than the risk of cancer in the pills
As in the case of the major product recall in the summer, warn doctors all patients, the controversial drug without consulting with your doctor sell. The risk of sudden and uncontrolled blood pressure spikes is many times higher than a contamination. There is also no need to opened packages back.
Patients the pressure-lowering drug are, nevertheless, due to the risk of cancer in your blood Provide could first of all ask the pharmacist whether your medication is one of the critical batches and with your doctor about switching to another blood pressure medication to speak. This would then have to issue a new prescription for the prescription drugs.
Most Sartans are clean – at least until now
Sartans, which are due to their good tolerability and low side effects popular, for example, through ACE-inhibitors and that have a similar mode of action. The German high pressure League advises.
Also for the most prescribed Sartan, Candesartan, so far there is no reason for a recall. In General, impurities for the vast majority of the sartanhaltigen medicines either not detectable, or only in very low amounts.
The pharmaceutical companies must now pay attention to clean production
The Committee for medicinal products for human use (CHMP) of the EMA is now calling for all pharmaceutical companies, the sartanhaltige blood pressure to review their manufacturing methods. After a transitional period of two years, you must prove that your blood pressure medicines have no measurable contaminants before they can be used in the EU.