Articles Posted in Drug Recall

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If you or a loved one has been taking the drug, Valsartan, you may have a claim against pharmaceutical companies for the distribution and sale of Valsartan medication that has been contaminated with toxic, cancer-causing substances.

On July 13, 2018, the FDA recalled the drug, Valsartan.  Valsartan is the generic form of Diovan, which is used to treat high blood pressure and heart conditions.  Because it costs less, the active pharmaceutical ingredient (API) for Valsartan is manufactured in countries outside of the United States.  Several of the foreign API manufacturers changed the manufacturing process in 2012, and this change is believed to have caused unintended byproducts, which contaminated the drug with impurities, including N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and/or N-Methylnitrosobutyric acid (NMBA). These toxic substances are classified as probable human carcinogens, meaning that they are more likely than not to cause cancer in humans.  Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs Limited (Hetero) in India are two of the API manufacturers that used the altered manufacturing process. ZHP has an estimated 45% of the US market share of the Valsartan API production. 

The APIs from ZHP and Hetero are used in finished pills, which are sold in the United States.  Many American pharmaceutical companies have made, distributed, marketed and/or sold Valsartan products containing the API containing toxic substances. It is believed that the contaminated pills have been sold in the United States since 2014 and that there have been millions of contaminated pills taken in the United States.  Based on tests, the API manufacturers were aware that Valsartan contained high levels of the toxic substances. The manufacturers minimized the information, citing testing inaccuracies. Eventually, after additional testing, the European Medicines Agency (EMA) issued recalls for Valsartan and the FDA followed.  The FDA initially issued a report that 1 in 8,000 people taking Valsartan may develop cancer, but scientific evidence show that the number of cancer cases is likely significantly higher.