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In Europe, a reminder of high blood pressure medications containing valsartan started as some batches of a Chinese manufacturer are contaminated with a carcinogen. With the reminder, the authorities want to play security.
Valsartan is present in several antihypertensive drugs. Now, production-related impurities have become known to Chinese manufacturer Zhejiang Huahai Pharmaceutical with N-nitrosodimethylamine. This substance is considered by the International Agency for Research on Cancer of the WHO and EU as likely to be carcinogenic to humans. Drug regulatory authorities reacted and ordered a recall of medicines containing the drug produced in China. The recall by pharmaceutical companies, which use the active ingredient of the Chinese manufacturer, is under way in 22 countries since July 4, including Canada and Bahrain. The US Agency of Medicines (FDA), however, sees no need for action.
BfARM sees no acute danger to patients
There is no acute danger to patients, said the Federal Institute of Drugs and Medical Devices (BfArM). "Patients taking drugs containing valsartan should not stop taking medications without consulting their doctor, as the health risk of being seduced is many times greater than the potential risk of contamination," BfArM said.
According to the German Medicines Agency, all batches concerned are recalled "as a precautionary measure". It is currently clarified throughout Europe whether and at what concentrations the carcinogenic substance is contained in the drugs that are derived therefrom. An initial scientific badessment of the danger potential had already taken place at European level, further investigations would continue, said the drug administration. The limit values for N-nitrosodimethylamine do not yet exist. The substance is also found in salted meat and alcoholic beverages.
Which drugs are concerned
Currently, the BfArM badumes that examinations can be completed in a short time. Lists of affected lots will then be available for pharmacies, among others. Since Thursday, pharmacies receive new messages, packets that they are no longer allowed to sell. Large pharmaceutical companies such as Ratiopharm, Hexal and Stada have already recalled their products. In addition to the original manufacturer Novartis, there are only three companies out of a dozen that are not affected.
There is no official list of drugs that are affected. This makes it difficult for doctors and patients to badess the risk potential. Some manufacturers have posted information on their websites, such as Novartis. What is certain is that all drugs containing valsatan are not affected. Because the active ingredient is produced by about 40 different companies, of which 20 are in India.
New drug scandal?
According to Apotheke Adhoc, the contaminated goods have been on the market for years. Behind this could hide one of the biggest drug scandals in recent history, writes the industry service. Zhejiang Huahai Pharmaceutical changed production in 2012 to make more profit. Thus, the blood pressure medication could already contain the carcinogenic substance for six years.
Valsartan is an antihypertensive drug and an angiotensin II receptor antagonist. Angiotensin II is an endogenous substance that narrows blood vessels and raises blood pressure. Valsartan counteracts this effect by dilating blood vessels and lowering blood pressure. Drugs containing valsartan are used for high blood pressure, heart failure or after a heart attack.
Photo: © redaktion93 – Fotolia.com
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