Issues with valsartan continue despite investigations and recalls

On Behalf of | Mar 15, 2020 | Pharmaceutical Litigation

High blood pressure and heart failure threaten the lives of numerous people here in Ohio and across the country. Unfortunately, some of the most prescribed medications for these conditions include valsartan as an ingredient, which became the subject of recalls in 2018 after it was discovered it contained an impurity identified as a probable human carcinogen. After more than a year since manufacturers began recalling medication containing this ingredient, the Food and Drug Administration is still discovering faulty manufacturing processes.

Amid growing concerns about the presence of NDMA in medications containing valsartan and other ingredients, the public may have trouble trusting in the prescription and over the counter drugs out there, and it appears the FDA may agree. The investigation into the presence of this impurity in high blood pressure ad heart failure medications remained ongoing by the FDA as of Nov. 2019. In fact, the agency’s investigation even crosses oceans.

On Nov. 13, 2019, the FDA issued a warning letter to an overseas manufacturer. According to the agency, the valsartan manufacturer fails to follow many of the required current good manufacturing processes. The letter specifically mentions the lack of written procedures outlining the “receipt, identification and handling of raw materials” at the facility. It also failed to follow procedures for the cleaning of utensils and equipment.

While the FDA continues its investigation and more manufacturers receive warnings, more patients worry they may receive a diagnosis of some form of cancer. Some of those patients could live here in Ohio. If one of them believes they now suffer from cancer due to the use of a medication containing valsartan or another ingredient or medication recalled due to the presence of NDMA, it may be worthwhile to discuss the situation with an attorney to determine what would be the appropriate action going forward.


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