Everyone likes to save money and especially when you have to pick up the same prescription every month, those medications add up. Doctors like to prescribe generic versions of drugs because it saves the patient money and contains the same active ingredient as the original manufacturer. But other manufacturers use different processes, resulting in different inactive ingredients, which do not have to be the same as the original medication. Generic versions of a drug used to stabilize blood pressure and prevent heart failure are being recalled in 22 countries because one of the ingredients poses a potential cancer risk.
Valsartan, originally developed by Swiss pharmaceutical company Novartis, is off-patent, meaning generics may be manufactured by other companies. Novartis is recalling Sandoz’s Valsartan and Valsartan HCT, which is distributed in 22 countries in Europe, citing “they do not meet our quality standards.” Products sold in the United States are not affected by the recall.
Chinese manufacturer Zhejaiang Huahai Pharmaceuticals discovered the presence of N-nitrosodimethylamine (NDMA) in its Valsartan products. These medications are being recalled across Europe while the European Medicines Agency (EMA) carries out a thorough investigation to determine the impact of this impurity. The impurity was discovered as a “result in the change of the manufacturing process.”
NDMA, a chemical used to make products such as rocket fuel and industrial lubricants, is a potent carcinogen. It can also be unintentionally produced through chemical reactions, resulting as a byproduct of pesticide and rubber tire manufacturing. In animal studies, NDMA can cause tumors in the liver, kidney, and intestinal tract. Exposure to high levels can cause liver damage in humans.
The FDA has no comment at this time and plans to evaluate the evidence itself rather than rely on third party information, however the US Department of Health and Human Services released a statement on the impurity. “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.”
That statement is as unsettling as it is confusing. If you are taking Valsartan, do not stop taking your medication. It would be wise to consult your doctor to discuss treatment options as a precaution. There are alternative medicines available.