[ad_1]
(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.
Related: More reports | More news about health
Valsartan is not the subject of a patent and is 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 since they "do not meet our high quality standards." British pharmacies are advised to recall batches of valsartan containing medicines manufactured by Dexcel Pharma Ltd and Accord Healthcare.
The recall concerns about 2,300 batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland. Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
Novartis spokesman Eric Althoff said that the products sold in the United States are not affected this recall. Sandy Walsh, spokeswoman for the US Food and Drug Administration, said the agency was aware of the situation and that she had "no comment to make," adding that the FDA " Commits to inform the public in a timely manner Generally, the agency does not comment on third-party ads, but evaluates them as evidence to better understand a particular issue and to contribute to our mission of protecting public health. "
The problem was discovered during batch testing of the active pharmaceutical ingredient (API) of valsartan, as those from an external vendor 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 is part of 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 pesticide manufacturing, rubber tire manufacturing or fish processing.
Animal studies have shown that NDMA can be toxic and cause tumors in the liver. leaflet. 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 quantities of NDMA found in 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 does not represent a significantly increased risk for patients treated with Sandoz Valsartan and Sandoz Valsartan HCT Film Tablets."
The European Medicines Agency and the 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 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 undertake an urgent review of all these products that may pose a low risk to public health" said Dr. Sam Atkinson, Director of the United Kingdom Division of Inspection , the application and standards of the Regulatory Agency for Medicines and Health Care Products
. Patients should discuss with their 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's vital that they touch with their doctors "as soon as possible." Alternative medications that are not affected by the recall are available.
"They are essential because patients should not stop taking their medication abruptly, which can be harmful," said Dr. Mary Ann Bauman, representative of the American Heart Association. . "You do not want to make any conclusions about this medicine or any other medicine yourself, first talk to your doctor."
The-CNN-Wire
™ & 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved.
Source link
