Blood pressure meds have been recalled over cancer fears after it was discovered that the widely prescribed drug may contain a carcinogen, Time magazine reported.
Three companies agreed to voluntarily pull the generic drug containing valsartan after the U.S. Food and Drug Administration reported that it may be tainted with the human carcinogen N-nitrosodimethylamine (NDMA).
The medication was manufactured in China by Zhejiang Huahai Pharmaceutical, which supplied the drugs to Major Pharmaceuticals, Teva Pharmaceutical Industries and Solco Healthcare.
The FDA said in a statement that the discovery of the carcinogenic component was unexpected and likely to be linked to changes in how the generic drug's active substance was manufactured.
"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," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Worryingly, because valsartan is used to treat serious medical conditions such as blood pressure, patients taking drugs containing the active component cannot simply stop taking their medication.
Instead, they should to continue taking the drugs until a replacement is found and should contact their health care professional, the FDA advised, according to Time.
The FDA said it would continue to investigate the matter and also assess the effects on patients while establishing measures to reduce the impure component in future batches.
The ordeal has reignited concerns regarding the safety of importing drugs into the U.S.
The FDA previously reported that imported medications and their ingredients may not have been evaluated for safety and effectiveness in the U.S., even if they were legal in foreign countries.
Additionally, the agency said some medication were unsafe when taken without adequate medical supervision and may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.
The Partnership for Safe Medicines added that "just because medicine purports to come from a supposedly safe country doesn't mean that the medicine itself was either manufactured or inspected for safety by the country's regulatory officials."
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