Common heart drug recalled from Malta and 21 other countries for possible cancer link

Sunday 08 July 2018 02:35 PM


A common drug used to control blood pressure and help prevent heart failure is being recalled in Malta and in 21 other countries because it contains a chemical that poses a potential cancer risk.

Valsartan is off-patent and is used as a component of other generic medicines. 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."

Pharmacies in the UK have been advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

The recall involves about 2,300 batches that were sent to Malta, Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina and Bahrain.

Novartis spokesman Eric Althoff said that products sold in the United States are not affected by this recall. The US Food and Drug Administration says it is looking to see whether it "has any information to share at this time" and directed questions to the manufacturer, as it is "the best source of information about their product."

The problem was discovered during tests of batches of valsartan's active pharmaceutical ingredient (API), as those from an external supplier contained an impurity. The European Medicines Agency reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is "a result of a change in the manufacturing process."