Global recall of heart drug due to potential carcinogen contamination

13 July, 2018, 14:58 | Author: Kara Nash
  • Health Canada

The alert comes after the watchdog issued a recall last week (July 6) for seven batches of valsartan-containing medicines made by Accord Healthcare and Dexcel Pharma Ltd, after an impurity was identified in their manufacturing process which "may have carcinogenic potential".

She continues, explaining that patients should go to the pharmacy and see "if the drugs they're taking are indeed the affected, recalled valsartan products". The drug regulator for the European Union said it would conduct an assessment of the severity of the problem for those who are now taking drugs containing Valsartan.

Pharmacies in 22 countries including 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 have been warned and asked to recall products containing Valsartan as a precaution. First created and sold as Diovan by the Swiss pharmaceutical company Novartis, Valsartan is now present in hundreds of generic drugs after Novartis' patent expired in 2012.

The valsartan used in the products contains an impurity, N-nitrosodimethylamine (NDMA), a chemical that could potentially cause cancer in humans with long-term exposure, according to the government agency. After its announcement on Saturday, the ministry launched on-site investigations of 82 pharmaceutical companies to check whether the drugs contain NDMA. He had been taking a recently banned drug for over two years.


Some of these drugs are also used in patients who have had heart failure or a recent heart attack.

Oh Beom-jo, a professor of family medicine at Dongguk University Medical Center, said, "Patients will be confused about whether their drugs are problematic or not".

Health Canada says patients taking the drug should check with their pharmacists to learn if their medicine is being recalled.

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