Earlier this month, the European Medicines Agency (EMA) announced that it was reviewing medicine containing valsartan and had advised national authorities to recall medicine containing the active ingredient.
The US Food and Drug Administration (FDA) has now taken the same step, after Zhejiang Hauhai had alerted authorities that it had discovered impurities in the ingredient that it produces.
The impurity is the ‘probable carcinogen’ N-nitrosodimethylamine; in regards to how this was introduced into the active ingredient, both the EMA and FDA suggested it had been introduced during a change in the manufacturing process.
When we approached the EMA to ascertain exactly what had changed and why this would see the impurity introduced, an EMA spokesperson stated that whilst the review is ongoing, the Agency could not provide further information.
The spokesperson clarified that once the review has been completed, the findings will be made public.
The FDA has named the companies which will engage in a voluntary recall of their products – it includes Teva Pharmaceuticals, Major Pharmaceuticals and Solco Healthcare for their valsartan medicine, and Teva and Solco for their valsartan/hydrochlorothiazide (HCTZ) medicine.
“We have carefully assessed the valsartan-containing medications sold in the US, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.