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27/11/2018
Impurities in the active ingredient
Valsartan: reminder of blood pressure
Photo: iStock / digicomphoto
Blood pressure in the review: Once again, valsartan, a substance contained in antihypertensives, was recalled. What you should consider now and why consultation with the doctor is so important.
The valsartan, blood pressure agent, is again subject to criticism – the drug from a manufacturer has been recalled because impurities have been found. Which lots are involved and which patients should be informed now.
The previous recall since July 2018 was not enough. Again, a drug from a drug manufacturer was recalled. It's pretty much a reminder valsartanBut this time, the drug comes from another manufacturer. Mylan Laboratories Limited lots are concerned this time – the drug from this manufacturer can not be manufactured without notice for the production of drugs containing valsartan.
Valsartan Recall: These lots are affected
Valsartan is a hypotensive agent used in a variety of drugs for hypertension. It is produced by different manufacturers around the world. Impurities have now been found in some traceable lots from Mylan Laboratories Limited of India.
It is N-nitrosodiethylamine (NDEA), a substance that can cause cancer. The fabric can form during the production of valsartan if it is not sufficiently worked.
In a statement, the company mentions the products and lots concerned:
- Valsartan lasted: 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 stop treatment!
Important: Anyone who discovers these medicines and the corresponding lots with the PZN numbers listed should never stop the treatment in a hurry!
Talk to your doctor. According to the company's announcement, the risk of cancer is not offset by the risk that occurs when the antihypertensive drug is stopped abruptly. Because the effects of untreated hypertension are more immediate.
Already reminders of Sartanen
The reminder of the hypotensive is not the first. It was not until early July that lots of valsartan were recalled because of impurities and the number of messages accumulates slowly. At the time, it was vsartanhaltige-based drugs from Chinese manufacturer Zhejiang Huahai Pharmaceuticals. Carcinogenic substances have been discovered. In September, it was reported that even the antihypertensives of the Indian manufacturer Hetero Labs were contaminated and were therefore recalled.
In addition, batches of the drug Irbesartan Heumann 300 mg are currently being recalled, as announced by the German League of Hypertension.
Despite the reminders and possible cancer risks: Do not just stop the drugs!
Sartans are among the agents used to treat high blood pressure, heart failure and the treatment of various cardiovascular diseases. Even after a heart attack, the preparations are often used.
Sartane is not alone in criticism. A recent study has shown that hypotensive drugs with ACE inhibitors can cause lung cancer. Cardiologists are skeptical.
The following rules, however, apply to infected sartans: antihypertensive drugs should never be interrupted in this way; consulting a doctor or pharmacist is absolutely necessary. Because the risk, which comes from unauthorized stopping, according to the German League of Hypertension, is several times greater than the potential risk of cancer coming out. Doctors tell you if you belong to a risk group and identify a replacement medication with you.
Here is a list of all the recalled Sartan medications, including the PZN. Until now, drugs from Novartis, TAD Pharma and Aurobindo should not be affected. However, the German Pharmacists confirms that in pharmacies already affected packaging should no longer be found. Consult your pharmacist, you should be uncertain!
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