Amid Increasing Drug Recalls, FDA Focuses on 2 Factories

Agency: Factories in China, India that made blood pressure drugs have equipment, process problems
By Jenn Gidman,  Newser Staff
Posted Jan 15, 2019 8:00 AM CST
FDA Eyes Foreign Plants That Made Drugs With Carcinogens
Check the FDA site to see if drugs you take have been recalled—then check with your doctor.   (Getty Images/digicomphoto)

With the significant number of drugs and drug ingredients made overseas, it's hard for the FDA to provide airtight oversight. But two plants in China and India that pump out oft-prescribed blood pressure and heart medications are now on the agency's radar after FDA tests revealed trace amounts of carcinogens in drugs made there, USA Today reports. The drugs in question, many of which have been recalled: valsartan, losartan, and irbesartan, all a class of drug called angiotensin II receptor blockers, or ARBs. The plants in question: China's Zhejiang Huahai Pharmaceutical and India's Hetero Labs, where FDA investigations have unearthed concerning equipment and procedural issues, including rusting and frayed gear (Zhejiang Huahai), equipment that wasn't regularly cleaned and sterilized (Hetero), and a failure to look into eyebrow-raising test results (both plants).

The FDA has been overwhelmed by how many inspections it has to do, and so has had to pick which sites require immediate attention and which have to wait. While it used to check factories (both domestic and overseas) at least once every two years, now it prioritizes plants considered riskiest to US consumers. Meanwhile, ARB recalls have been expanding. "The last thing you'd expect when you are taking a drug of this nature is, 'I may have been exposing myself to a carcinogen for years,'" a Philly attorney representing patients who've taken drugs from the two plants tells USA Today. The paper warns, however, that patients who use these recalled products should consult with their doctors before ceasing to take the meds, as abruptly stopping could cause more immediate harm. Check the FDA site for updates on the recalls. (Teva Pharmaceuticals recently pulled back two drugs.)

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