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Valsatran drugs are often administered to control high blood pressure and prevent heart failure. The drug is currently being recalled in 22 countries after the discovery of traces of a carcinogenic chemical during tests. ( Charles Thompson | Pixabay )
A commonly prescribed drug is now being recalled after tests have detected traces of a chemical that could potentially cause tumors and cancer. How did it happen?
Valsartan Recall
On July 5, the European Medicines Agency announced that it was reviewing batches of valsartan after a test revealing that they contained an impurity that may pose cancer risks .
the agency is studying valsartan provided by Zhejiang Huahai Pharmaceuticals in Linhai, China. It has been found to contain N-nitrosodimethylamine or NDMA, a substance considered to be a probable carcinogen for humans by the US Department of Health and Human Services.
According to EMA, the presence of NDMA in valsartan was unexpected and perhaps due to changes made in the way it is made. Still, while investigations are ongoing, pharmacies are being asked to recall medications with the active ingredient valsartan.
Although the products in the United States are not affected by the recall, 2,300 lots of valsartan sent to Austria, Belgium, Bulgaria, Bahrain, Bosnia and Herzegovina, Canada, Croatia, France, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Sweden and Spain are involved.
] In light of this recall, patients are advised not to stop taking valsartan medications abruptly. Instead, they should contact their health care providers if they have any concerns or questions regarding the recall. It is worth noting that all Valsartan drugs are not affected by the recall, but only some that have been sent to Europe
That said, patients may be prescribed with different medications on their next prescription while the investigations are in class. The EMA is assessing whether the discovered impurity poses a risk to patients and will provide new information as soon as it is available. The review will focus on Zhejiang Huahai Pharmaceuticals' valsartan, but may also cover other Valsartan drugs that may have been affected.
"Our highest priority is to make sure that the medications you are taking are safe," said Dr. Sam Atkinson of the Medicines Regulatory Agency and Health Care Products.
Valsartan and NDMA
Valsartan is an active ingredient in many drugs for the treatment of high blood pressure, heart failure and recent heart attacks. It is available as a standalone drug or as an active ingredient in combination with other active substances.
NDMA, on the other hand, is a semi-volatile organic component that is part of a family of potent carcinogens. It was formerly used in the production of rocket fuel and antioxidants and can be unintentionally produced from chemical reactions in industrial settings.
In previous animal studies using various species, it was found that exposure to NDMA caused tumor growth in the liver. , blood vessels, and the respiratory tract.
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