Common medication recalled for possible link to cancer
Blood pressure medication may poses a potential cancer risk.
Valsartan is a medication used to treat high blood pressure and congestive heart failure and to extend the lives of those who've suffered heart attacks, but now the life-saving drug may carry a death sentence, revealed Edition.com on the 6th of July 2018.
Novartis, the company that originally developed Valsartan has declared that the medication which is now off-patent is being used as a component in other generic medicines with uncertain quality and safety.
Sandoz valsartan and valsartan/HCT film-coated tablets are now being recalled in pharmacies throughout the UK since they "do not meet our high-quality standards."
Pharmacies are also being advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare
" They key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful,"
Dr. Mary Ann Bauman, American Heart Association, Edition.com, 6th of July 2018.
This recall affects 2,300 batches that were 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.
Eric Althoff, the Novartis spokesman in the US has assured the public that the products sold in the United States are not affected by this recall.
The spokeswoman for the US Food and Drug Administration, Sandy Walsh, has confirmed that the agency is aware of the situation and "has no comment at this time."
Walsh declared that the FDA is "committed to informing the public in a timely manner when the agency identifies safety issues", and will not comment on third-party issues or regarding events taking place in areas outside their jurisdiction.
The European Medicines Agency discovered the problem with the medication while reviewing medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency explained that the impurity is "a result of a change in the manufacturing process."
A blood pressure drug taken by tens of thousands of people in Britain is being withdrawn over fears that some supplies are contaminated with a chemical that causes cancer https://t.co/trqlHkaEsP— The Times (@thetimes) July 6, 2018
The contaminant found present in valsartan is N-Nitrosodimethylamine (NDMA), an organic chemical that is a potent carcinogen.
Animal studies have shown that NDMA can cause tumors in the liver, kidney and respiratory tract. Exposure to high levels can cause liver damage and is a probable human carcinogen.
The European Medicines Agency and EU regulators are working to determine what impact this might have on patients and whether other drugs will be affected.
The Finnish Medicines Agency has called on pharmacies and hospitals to stop distributing some varieties of Valsartan. It is estimated that over 20,000 people in Finland use the drug.
Fimea has recommended that patients who use it contact their local pharmacy for substitutes but should not stop taking their medications without consulting their doctors.
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