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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 off-patent and is used as a component of other generic drugs.
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 off-patent and is used as a component of other drugs. generic medicines. Novartis, the company behind the drug, said that Sandoz valsartan and valsartan / HCT film-coated tablets are recalled because 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 involves approximately 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 products sold in the United States are not affected by 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 " Undertakes to inform the public in a timely manner problems.As a rule, the agency does not comment on the third-party ads, but evaluates them as part of the overall set of evidence to better understand a particular problem and contribute to our mission of protection of public health. "
batch tests of the active pharmaceutical ingredient (API) of valsartan, because 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 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. "There is no certainty as to how much this contaminant can potentially increase the risk of cancer in humans, so the amount of NDMA found in the Valsartan API would not pose a significantly increased risk to patients." taking coated tablets Sandoz Valsartan and Sandoz Valsartan HCT. "
The European Medicines Agency and European 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 Inspection Division , the application and standards of the Agency for the Regulation of Drugs 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 is vital that they contact their doctors "as soon as possible . " Alternative medications that are not affected by the recall are available.
"They are essential with this, patients should not stop taking their medi cation abruptly, this can certainly be dangerous," said Dr. Mary Ann Bauman, a representative of the American Heart Association. "You do not want to make any conclusions about this medicine or any other medicine yourself, so discuss it with your doctor first."
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