Tainted drugs: Ex-FDA inspector warns of dangers in US meds made in China, India
The notice arrived at the home of Denise Schreck, a New Jersey woman who suffers from high blood pressure, last July.The blood pressure medication used by Schreck and millions of other Americans was tainted. The culprit? A chemical with the potential to cause cancer.
The shift has contributed to a flood of recent recalls and fueled escalating concerns about the safety of medicines consumed in the U.S. With U.S. inspectors scrambling to review a sprawling network of overseas drug production plants, the FDA is often left to rely on the word of the facility managers, Motamed said.
"The same is not true of a foreign facility. I've had inspections where I really could have benefited from the extra time and I knew there were problems to be uncovered, but I had to leave the country." But three months later, he was overruled by FDA management. The FDA decided to allow Zhejiang Huahai to voluntarily fix the problems on its own, the agency wrote in an official document obtained by NBC News, citing the firm's compliance history and mostly"adequate responses" to impurities in their testing.
In a statement to NBC News, Zhejiang Huahai said it's"working closely with regulators here and abroad to evaluate the source of the impurities that resulted in the recall" and is determining if"any modifications to its manufacturing processes are necessary." "Almost from prescription to prescription, I would find significant changes in my blood pressure," said Grybb, 68, of Michigan.
Experts said the contaminants are still powerful at low levels."This is well beyond the risk that government agencies typically deem acceptable," said Lisa Lefferts, senior scientist at the Center for Science in the Public Interest."While most people won't get cancer from the contaminants in these pills, it's an unacceptable risk, and avoidable."of medications free of the probable carcinogens and says it has been working to mitigate and prevent shortages.
The Association for Accessible Medicines, the trade group for generic drug manufacturers, said its"member companies with affected products voluntarily recalled their medicines containing valsartan and have worked closely" with the FDA.
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