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(CNN) – A drug commonly used to control blood pressure and help prevent heart failure is being recalled in 22 countries because it contains a chemical that presents a potential risk of cancer.
Valsartan is an off-patent product used as a component of other generic drugs. Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan / HCT film-coated tablets are being recalled because they "do not meet our quality standards." British pharmacies are advised to recall batches of valsartan containing medicines manufactured by Dexcel Pharma Ltd and Accord Healthcare.
The recall concerns approximately 2,300 consignments sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria and Ireland. Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
Novartis spokesman Eric Althoff said that products sold in the United States are not affected this recall. The US Food and Drug Administration says it's looking into whether it "has information to share right now" and has questions to the manufacturer because it's "the best source of information on his product ".
was discovered during batch testing of the active pharmaceutical ingredient (API) of valsartan, as those from an external supplier contained an impurity. The European Medicines Agency has reviewed the supplier's medicines, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is "the result of a change in the manufacturing process."
The impurity is N-nitrosodimethylamine (NDMA), an organic chemical that belongs to a family of potent carcinogens. The chemical has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced by certain chemical reactions and is a by-product of the manufacture of certain pesticides, the manufacture of rubber tires or the processing of fish.
Animal studies have shown that NDMA can be toxic tract. It can also be potentially dangerous for humans in certain quantities. According to the US Department of Health and Human Services, exposure to high levels can cause liver damage and is probably carcinogenic to humans. "The amounts 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 email. "The amount of NDMA found in the Valsartan API would not represent a significantly increased risk for patients treated with Sandoz Valsartan and Sandoz Valsartan HCT. […]
Tablets The European Agency for Drugs and Medicines EU regulators are working to determine what impact this could have on patients and if any other drugs will be affected.The external provider is also used by other pharmaceutical companies, according to the Novartis statement, but the spokesman said that he could not comment on these companies.The company says that no other Sandoz or Novartis product, even those that may contain valsartan, is affected by the recall.
"We continue to urgently review all of these products that may pose a low risk to public health," said Dr. Sam Atkinson, Director of the Health and Safety Division. 9, inspection, enforcement and standards of the UK Regulatory Agency for Medicines and Health Products
although the amount of NDMA in the drug is not considered "Patients should discuss with your doctor to discuss treatment options as a precautionary measure.
Patients should not stop taking their medications, but the Medicines and Health Products Regulatory Agency has stated that it is vital that they communicate with them. as soon as possible. "Alternative medications not affected by the recall are available.
" They should not stop taking their medication abruptly, it can certainly be dangerous, "said Dr. Mary Ann Bauman, Representative from the American Heart Association .. "You do not want to draw any conclusions about this drug or any other medication, talk to your doctor first." [19659002] The-CNN-Wire ™ & © 2018 Cable News Network, Inc., a Time Warner Company, All Rights Reserved
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