(CNN) – A common drug is being recalled in 22 countries to control blood pressure and prevent heart failure, as it contains a chemical that poses a potential cancer risk.
Valsartan is patent-free and is used as part of other generics. Novartis, the company that originally developed the drug, said that Sandoz Valsartan and Valsartan / HCT film-coated tablets are recalled because they "do not meet our high quality standards." Pharmacies in the UK are advised to recall valsartan batches containing medicines from Dexcel Pharma Ltd and Accord Healthcare.
The recall includes about 2,300 batches that are to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia were sent and Herzegovina, Bahrain and Malta.
Novartis spokesman Eric Althoff said that products sold in the United States are not affected by this recall. The US Food and Drug Administration (FDA) wants to find out if it has "information to share at the time" and ask questions to the manufacturer as it is "the best source of information for their product."
The problem was discovered in tests on batches of Valsartan's Pharmaceutical Ingredient (API), as those from an external supplier contained an impurity. The European Medicines Agency reviewed pharmaceuticals from supplier Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the contamination is "a consequence of a change in the manufacturing process".
The contaminant is N-nitrosodimethylamine (NDMA), an organic chemical that is in a family of strong carcinogens. The chemical has been used to produce, among other things, liquid rocket fuel, plasticizers and lubricants. It can also be produced unintentionally by certain chemical reactions and is a by-product in the manufacture of pesticides, the production of rubber tires or fish processing.
Animal studies have shown that NDMA can be toxic and can cause tumors in the liver, kidneys and respiratory tract. It can also be potentially harmful to people in certain amounts. Exposure to high concentrations may cause liver damage, according to the US Department of Health, and is likely a human carcinogen.
"The levels of NDMA found in the Valsartan API are much lower than the cumulative endogenous production and the usual external exposure of NDMA," Althoff wrote in an e-mail. "There is no certainty about how much this pollutant could potentially increase human cancer risk, so the amount of NDMA found in the Valsartan API would not significantly increase the risk for patients taking Sandoz Valsartan and Sandoz Valsartan HCT film. " Dragees. "
The European Medicines Agency and EU regulators are working to identify what impact this might have on patients and whether other medicines will be affected. The outside vendor will also be used by other drug companies, according to Novartis, but the spokesman said he could not comment on these companies. The company says no other Sandoz or Novartis products, even those that might contain valsartan, are affected by the recall.
"We will continue to undertake an urgent review of all these products, which may pose a low risk to public health," said Drs. Sam Atkinson, Head of Inspection, Enforcement and Standardization of the Regulatory Authority of UK Medicines and Health Products.
Novartis said that although the amount of NDMA in the drug is not considered a "significantly increased risk to patients," patients should talk with their doctors to discuss treatment options as a precautionary measure.
Patients should not discontinue their medication, but the Regulatory Authority for Medicines and Health Products said it was important that they get in touch with their doctors as soon as possible. Alternative medicines that are not affected by the recall are available.
"The key to this is that patients should not stop taking their medication abruptly, which can definitely be harmful," Dr. Mary Ann Bauman, a representative of the American Heart Association. "You do not want to draw your own conclusions about this medicine or any medications – talk to your doctor first."
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