Sartan case: Aurobindo, Walmart sued; Teva recalls drugs made with Mylan’s API

By PharmaCompass

2018-12-06

Impressions: 70 Article

There is more to report on the sartan case. In the US, litigation over the tainted blood pressure medications continued to grow with a class-action lawsuit filed in Florida against Walmart and three drug companies — Indian drugmaker Aurobindo Pharma, US drugmaker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals.

The class action suit has been filed against the four over the sale of irbesartan since the drug contained the impurity, N-nitrosodiethylamine (NDEA).

In October, the FDA had reported that Aurobindo was recalling 22 batches of its irbesartan API because it was found to contain NDEA. Days later, ScieGen and its distributor Westminster initiated a nationwide voluntary recall to the consumer level of all lots of unexpired irbesartan tablets because they had been made with the Aurobindo API and then shipped to Walmart.

The Florida litigation is just one in the growing list of lawsuits filed since the global recall of a host of high blood pressure drugs began this summer when both the FDA and regulators in Europe learned that the valsartan API made by China’s Zhejiang Huahai Pharmaceuticals contained NDEA and NDMA (N-Nitrosodimethylamine) impurities.

Last week, Mylan and Teva Pharmaceuticals began recalling valsartan products after Mylan reported that the NDEA impurity was found in some of the API made at one of its Indian plants and Teva had used that API to manufacture its products. Teva said it is recalling to the patient level all lots, 49 in all, of its valsartan products in the US. They include its amlodipine and valsartan combination tablets and amlodipine, valsartan and hydrochlorothiazide combination tablets.

The FDA said there is very little risk of the impurities causing problems and no adverse reactions have been seen. Yet, they continue to ask drugmakers to pull their products off the market when impurities are detected. There are still lots of blood pressure medications that have been unaffected by the recalls.

FDA is alerting patients and healthcare professionals to Teva’s voluntary recall of valsartan-containing products manufactured using API from Mylan, which voluntarily recalled valsartan-containing products on November 20.

Mylan NV said on Tuesday it was expanding a nationwide recall of blood pressure medicine valsartan, recalling 104 additional lots “out of an abundance of caution” after the valsartan-containing products were found to contain traces of a probable cancer-causing impurity.

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