Valsartan Drug May Have Contained Cancer-Linked Impurity Since 2012
According to a statement made by European regulators earlier this week, valsartan, common blood pressure, and heart medication, may have contained an impurity that has been linked to cancer since 2012.
The European Medicines Agency and the U.S. Food and Drug Administration are currently recalling valsartan products affected by an impurity known as NDMA (N-nitrosodimethylamine), which lab tests indicate may cause cancer in humans after long-term use.
Affected valsartan drugs were manufactured in bulk by a Chinese company at Zhejiang Huahai Pharmaceutical, where manufacturing processes changed back in 2012. According to EMA, the changes in the manufacturing of valsartan likely led to the NDMA impurity which was not detected by the tests routinely performed by Zhejiang Huahai.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement, “We have carefully assessed the valsartan-containing medications sold in the United States, 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.”
EMA, who initiated the concerns over the drug on July 5, is working to determine which patients have been exposed and to what extent.
If you or a loved one developed cancer or suffered from health complications after using valsartan, it is important to speak with an attorney who specializes in dangerous drug litigation.
When represented by The Potts Law Firm, your case will be examined both legally and medically. Our experienced medical team will examine your medical records, while our legal professionals assist you through the entire litigation process.