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Valsartan: Again, recalled blood pressure due to contamination



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11/27/2018

Contaminants in active ingredient
Valsartan: recalled blood pressure

Blood pressure in the review: Again, valsartan, a substance in antihypertensive drugs, recovers. What you should think about now and why the consultation with the doctor is so important.

Photo: iStock / digicomphoto

Blood pressure in the review: Again, valsartan, a substance in antihypertensive drugs, recovers. What you should think about now and why the consultation with the doctor is so important.

The blood pressure drug valsartan is again in criticism – again, a manufacturer's drug was withdrawn due to contamination found. Which parties are concerned and what patients should be aware of now.

The previous revocation since July 2018 was not enough. Now a drug was recalled by a drug manufacturer. It's about once more valsartan recallBut this time, the drug comes from another manufacturer. Batches of Mylan Laboratories Limited are affected this time – the drug from this manufacturer may not be manufactured until further production for valsartan medicines.


Valsartan recall: These rates are affected


Valsartan is a hypotensive agent used in a variety of high blood pressure medicine. It is produced by different manufacturers all over the world. The contaminants have now been found in some traceable rates from Mylan Laboratories Limited of India.


It is N-nitrosodiethylamine (NDEA), a substance that can cause cancer. The fabric may be formed in the preparation of valsartan if it has not worked well enough.



In a statement, the company mentions the products and parties concerned:


  • Valsartan dura: 40 mg, 80 mg, 160 mg and 320 mg; 28, 56 and 98 film-coated tablets; PZN 09239582, 09239599, 09239607, 09239613, 09239636, 09333803 and 09333826
  • Valsartan / HCT (Valsartan, Hydrochlorothiazide) Mylan: 80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg, 320 mg / 12.5 mg, 320 mg / 25 mg; 6 and 98 film-coated tablets; PZN 10054959, 10054965, 10054971, 10054988, 10054994, 10055002, 10055019, 10055025, 10055031 and 10055048

What patients should do now: do not just stop therapy!


important: Anyone who discovers these medicines and respective lots with the specified PZN (central drug number) should never stop treatment!


Talk to your doctor. Cancer risk, according to the company's announcement, is not offset by the risk that occurs when blood pressure medication is stopped suddenly. Because the effects of untreated hypertension are more immediate.


Already, reminders of Sartanen increased


The withdrawal of the hypotensive drug is not the first. It was not until early July that batches of Valsartan were recalled due to contamination, and the number of messages is slowly increasing. At that time there were valsartan-containing drugs from the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, where carcinogens were found. In September, there was a report that even antihypertensive agents from the Indian manufacturer Hetero Labs were infected and therefore recalled.


In addition, rates of the drug Irbesartan Heumann 300 mg, as reported by the German hypertension member, are withdrawn.


Despite recalls and possible cancer risk: do not stop medication only!


Sartans are among the agents used to treat high blood pressure and heart failure and to help with various cardiovascular diseases. Even after heart attacks, preparations are often used.


Sartane is not alone in the criticism. Recently, a study has shown that blood pressure medication with ACE inhibitors can cause lung cancer. Cardiologists are skeptical.


However, as with the contaminated sartans, blood pressure lowering medication should never be interrupted, so it is absolutely necessary to consult a doctor or pharmacist. Because the risk arising from unauthorized discontinuation, according to the German hypertonic league, is many times higher than the potential risk of outgoing cancer. Doctors advise if you belong to a risk group and identify with you if a replacement drug is needed.


Here is a list of all recalled Sartan drugs including PZN. To date, drugs from Novartis and TAD Pharma and Aurobindo should not be affected. However, the German Pharmacy's newspaper confirmed that packages would no longer be found in pharmacies already affected. Consult your doctor, you should be unsure!


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