FDA investigates foreign plants that made drugs with cancer-causing impurities
Wed, 01/16/2019 – 17:05
FDA has launched an investigation of plants in China and India that produced carcinogen-tainted ingredients that led to numerous recalls of blood pressure drugs in recent months. Drug firms recalled many lots of angiotensin II receptor blockers, including the front-line blood pressure and heart medications valsartan, losartan, and irbesartan—alone or in combination with other drugs—after trace amounts of cancer-causing impurities were detected by testing. FDA inspections indicated China’s Zhejiang Huahai Pharmaceutical factory and India’s Hetero Labs were having problems before the discovery of the contaminated drugs. Workers at the Chinese facility, which was the source of the blood pressure drug recalls, frequently failed to probe testing anomalies in drug batches, while fraying gaskets, rusted screws, and missing pieces also were observed. Yet the factory remained in operation despite these findings. A later inspection found intolerable levels of the carcinogen nitrosodimethylamine (NDMA), which prompted FDA investigation in June and a recall in July. Follow-up testing identified another carcinogen, nitrosodiethylamine (NDEA), in batches of valsartan. Problems FDA cited at the Indian plant included failures to check discrepancies in drug batches and infrequent cleaning, sanitization, or sterilization of equipment to prevent drug ingredient contamination.
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Source: Pharmacy Today | www.pharmacist.com