The U.S. Food and Drug Administration is being accused of not doing enough to ensure carcinogens aren’t contaminating drugs during the manufacturing process.

Valsartan was recalled worldwide in 2018 following studies that found the blood pressure medication contained unacceptable amounts of toxins. The drug is taken by about 3 million Americans every year. Now an independent lab is taking the FDA to task with claims it needs to make a greater effort to ensure the drug-making process doesn’t create unwanted impurities.

Petition Filed by Valisure

A citizens petition filed by Connecticut-based independent laboratory Valisure in June 2019 claims that the FDA has not created acceptable limits for harmful solvents like Dimethylformamide, or DMF, that are used in the drug-making process. 

DMF has been linked to kidney and liver damage as well as reproductive harm, according to the New Jersey Department of Health. Valisure believes the use of DMF as a solvent in the manufacturing industry could be responsible for impurities in the nation’s drug supply. 

The FDA has established acceptable limits for certain impurities like NDMA and NDEA. Both chemicals are cancer-causing carcinogens and can be a by-product of the manufacturing process. Both were also found in valsartan in 2018, sparking recalls. The levels of impurities were trace amounts, but that was still deemed unacceptable. 

There are several active lawsuits following the global recall of valsartan in 2018 and the discovery of cancer-causing chemicals in the drug. As of June 2023, there haven’t been any trials scheduled or settlements. More than 1,200 cases are still pending in court. Since valsartan is a generic medication, the ongoing lawsuits include 20 drug manufacturing companies and distributors.

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FDA Investigates Chinese Manufacturer

In August 2018, the FDA spent two weeks investigating the plant in China where valsartan is made after finding impurities in the drug. The agency discovered that Zhejiang Huahai Pharmaceutical had made changes to the manufacturing process that created the impurities in the drugs. 

The FDA said ZHP made changes at the plant in 2011 without thorough tests. That led to the FDA reprimanding the drug maker. ZHP also didn’t conduct or document a formal risk assessment following the changes. It used an outside firm to conduct research, which led to the decision to make manufacturing changes. The FDA said more investigation is needed. 

Valsartan Renal Failure Risk

According to an April 2023 article from the online medical news journal Healio, a slight risk of renal failure can exist for some people switching to valsartan. Those with heart failure who are transitioning from ARBs, ACE-inhibitors or direct renin inhibitors could also experience declines in renal function.

Dr. Scott D. Solomon, professor of medicine at Harvard Medical School and senior physician at Brigham and Women’s Hospital, wrote in the Journal of the American College of Cardiology that the risk is “highly variable, usually mild, and partially recoverable in most patients.”