A common blood pressure and heart medication containing valsartan has been recalled in 22 countries due to fears the drugs could contain a chemical linked to cancer.
Valsartan is commonly used to treat heart failure and high blood pressure and is used in a variety of generic medications.
A spokesman for Novartis, the company that originally developed valsartan, said Sandoz valsartan and Sandoz valsartan/HCT film-coated tablets were being recalled because they “do not meet our high quality standards,” reports CNN.
The public was warned about the problem last week after tests by supplier Zhejiang Huahai Pharmaceuticals in Linhai, China, found an impurity in valsartan’s active pharmaceutical ingredient, API. The impurity, a chemical called N-nitrosodimethylamine (NDMA), has been classified as a likely human carcinogen and can cause liver damage in individuals exposed to high levels.
The organic chemical has been used in the production of lubricants, softeners and liquid rocket fuel, according to CNN. NDMA is also produced as a by-product from the manufacture of products including pesticides and rubber tires, as well as from fish processing.
After reviewing drugs from the supplier, the European Medicines Agency (EMA) said the impurity is “a result of a change in the manufacturing process,” reports CNN.
According to a Novartis statement, Zhejiang Huahai Pharmaceuticals is used as an external supplier by pharmaceutical companies; however, Novartis noted that it was unable to comment on those companies. EU regulators and the EMA are currently investigating whether other drugs may also be affected.
The recall affects around 2,300 batches of valsartan that were sent to countries including: Austria, Bahrain, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
As a precaution, the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) has urged pharmacies in the UK to recall all batches of medicines containing valsartan made by Dexcel Pharma Ltd and Accord Healthcare.
Experts recommended that people who may be affected by the recall discuss alternative treatment options with their doctors.
“People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise on alternative treatment,” Dr Sam Atkinson, MHRA’s Director of the Inspection, Enforcement and Standards Division, said in a statement published by the UK government.
“We will communicate the outcome of our investigations and ensure that any other affected products are recalled,” he added. “Our highest priority is to ensure that the medicines you take are safe.”
Novartis spokesman Eric Althoff told CNN that there is unlikely to be an elevated cancer risk associated with the amount of NDMA found in the medication.
“The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA,” Althoff wrote in an email to CNN. “There is no certainty as to how much this contaminant may potentially increase cancer risk in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk to the patients taking of Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets.”