EMA – A heart drug that might lead cancer

The heart drug Valsartan is off-patent and it is being recalled in 22 countries. It is a common drug used to control blood pressure and prevent heart failure. The reason it has been recalled off is its chemical ingredient that is being looked down as a potential cancer risk.

Originally developed by Novartis, the company explains that the Valsartan coated tablets are being recalled because they do not meet the high quality standards of the company. Valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare have been recalled. The recall involves around 2,300 batches 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.

Tests were conducted upon the batches of Valsartan’s active pharmaceutical ingredient (API) by European Medicines Agency (EMA). The results suggested that the medicines reviewed from external supplier Zhejiang Huahai Pharmaceuticals in Linhai, China contained an impurity. As per the agency, the impurity was caused due to change in manufacturing process. The impurity is N-Nitrosodimethylamine (NDMA), an organic chemical that is in a family of potent carcinogens. The chemical is being used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

Animal studies have shown that NDMA can be toxic and potentially harmful to human in certain quantities. Exposure to high level may lead to human carcinogen said 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”, wrote Althoff in an email.

The EMA is still working on it to find the potential risk to the patients and whether other drugs are affected. Dr. Sam Atkinson, the director of the UK Medicines and Healthcare products said that “We continue to undertake an urgent review of all these products that may pose a low risk to public health.” Novartis said that although the amount of the NDMA in the drug isn’t considered a “significantly increased risk to the patients,” patients should talk with their doctors to discuss treatment options as a precaution.

Patients shouldn’t stop taking their medicine, but the Medicines and Healthcare products Regulatory Agency said it is vital that they get in touch with their doctors “as soon as possible. Alternative medicines that are unaffected by the recall are available.”

“The key is patients should not stop taking their medication abruptly, that definitely can be harmful. You don’t want to jump to any conclusions on your own about this medication, or any medication. Definitely talk with your doctor first”, said Dr. Mary Ann Bauman a representative for the American Heart Association.

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