Another batch of blood pressure drugs recalled over traces of cancer-causing chemical 

Another batch of blood pressure drugs recalled over traces of cancer-causing chemical

  • Last summer, it emerged valsartan produced in China was contaminated with a carcinogen called NDEA, prompting a global recall
  • Now, the same has happened with an Indian manufacturer
  • More than two-thirds of all active drug ingredients originate in China and India 

Another batch of blood pressure drugs have been recalled over fears they contain traces of a cancer-causing chemical.  

Valsartan was originally developed by Novartis, marketed as Diovan, but it is now off patent and US patients can instead use generic versions from various companies around the world. 

However, last summer it emerged some produced in China had been contaminated with a carcinogen called NDEA, prompting a global recall. 

And now, US regulators say an Indian generic drugmaker, Aurobindo Pharma Ltd, will recall 80 lots of medicines containing the blood pressure drug for the same reason.

In 2018, it emerged valsartan produced in China was contaminated with a carcinogen called NDEA, prompting a global recall. Now, the same has happened with an Indian manufacturer

In addition to tackling high blood pressure, it is also prescribed to treat heart failure. 

The impurity NDEA (N-Nitrosodiethylamine) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.

The announcement comes a month after Mylan NV said it will recall all lots of its blood pressure medicines containing valsartan after global health authorities clamped down on the drug.

The FDA said it will continue to investigate and test all blood pressure drugs for the presence of NDEA and another probable carcinogens.

In October last year, the FDA halted imports of drug ingredients or medicines containing ingredients produced at Zhejiang Huahai Pharmaceuticals, a Chinese factory which bulk manufactures valsartan.

More than two-thirds of all active drug ingredients originate in China and India, industry experts estimate.

This case shows, yet again, how heavily consumers around the world rely on medicines made in India and China.

While regulators are intensifying their inspections, they warn there is far more to be done.  

‘We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,’ said the European Medicines Agency’s Executive Director Guido Rasi, writing recently in the agency’s annual report.

 

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