Valsartan recalled in 22 countries due to failed quality standards

Valsartan is commonly used to control patients blood pressure and helps to prevent heart failure. However, the drug is now being recalled in 22 countries around the world as it’s been discovered that it contains chemicals that could pose a cancer risk. Valsartan was originally developed by the company Novartis, who say that Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled, due to the fact that they “do not meet our high quality standards.”

The risk was initially discovered during tests of the drugs active pharmaceutical ingredient, which is produced by an external supplier – Zhejiang Huahai Pharmaceuticals in Linhai, China. It was found that some of the batches contain an impurity. The European Medicines Agency reviewed medicines say this is “a result of a change in the manufacturing process.”

The impurity that’s been found is N-Nitrosodimethylamine (NDMA). In animal studies, it’s been shown that NDMA can be toxic and it could cause tumours in the kidney, liver and respiratory tract. Studies have also shown that in large quantities it can be harmful for humans and high exposure can lead to liver damage.

According to the US Department of Health and Human Services: “The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA. 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.”

The recall affects an estimated 2,300 batches. These batches 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. Additionally, pharmacies in the UK has been advised to recall batches that were produced by Dexcel Pharma Ltd or Accord Healthcare.

Eric Althoff, a Novartis spokesman said that products in the US aren’t affected by the recall. Sandy Walsh, a spokeswoman for the US Food and Drug Administration said the agency “has no comment at this time,” adding that the FDA is “committed to informing the public in a timely manner when the agency identifies safety issues. Generally, the agency does not comment on third-party announcements, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

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