Months after the U.S. Food and Drug Administration issued a recall on 3 blood pressure medications, the federal regulatory organization is investigating factories that may have tainted the drugs with carcinogens. According to recent reports, FDA inspections of plants in India and China where the drugs were manufactured show issues going back years.
Blood pressure and heart medications valsartan, losartan, and irbesartan were among the dozens of drugs recalled by pharmaceutical companies, after tests detected trace amounts of cancer-causing impurities. Although the FDA is continuing to investigate the cause of these impurities, their initial inspection has already revealed issues at a Zhejiang Huahai Pharmaceutical factory in China and at Hetero Labs factory in India.
Upon visiting the Zhejiang Huahai Pharmaceutical factory in Linhai, FDA inspectors reported that workers consistently either forgot or chose not to examine testing abnormalities. Equipment at the factories was also found to be frayed, rusty, and missing parts. Despite reporting these findings, the factory remained open until June, when the carcinogen nitrosodimethylamine, or NDM was detected, leading to July’s blood pressure medication recall. Subsequent tests also revealed the presence of carcinogen nitrosodiethylamine, or NDEA, in selections of valsartan. In September, the FDA issued an order to block products from the Huahai Pharmaceutical plant from entering the country.
Meanwhile, the Hetero Labs factory has been under suspicion by the FDA since 2016, when they were found shredding batches of documents before inspectors arrived for an oversight visit. Hetero also failed to require a defective batch of finasteride until inspectors discovered a customer complaint. Although the FDA did not attempt to block imports from entering the U.S., it did issue warning letters to Hetero Labs in 2017, stating that the manufacturer was not properly handing equipment, and suggesting it hire a consultant to oversee discrepancies.
This recall comes as the FDA continues to experience difficulty in providing oversight for the global parametrical market. As much as 80% of drug ingredients and 40% of finished drugs supplied in the U.S. are imported from over 3,000 overseas plants. As of 2017, about 1,000 of these plants had never been inspected by the FDA. Although the FDA has gotten better about appointing offshore inspectors, the Government Accountability Office reports that the FDA is still about 15% under target for these positions. As the agency has struggled to keep up with the demands of the global market, 300 products on average have been recalled by 65 plants within one year of inspection.
While it is still unknown how many Americans on valsartan have been impacted by the recall, roughly 103 million adults in the U.S. have high blood pressure, according to the American College of Cardiology, the American Heart Association, and other researchers. These reports are based on new guidelines for diagnosing hypertension, which speculate that 36% of adults require blood pressure medication.
According to the FDA database, 2,695 patients taking valsartan reported “adverse events” in the first 9 months of 2018, the most reported by valsartan patients in over 2 decades. This was also twice the number of adverse events reported to the FDA in 2017, which was just 1,382.
Making the issue more difficult for patients taking blood pressure medication is the fact that it is generally considered medically unadvisable to stop taking these drugs abruptly, as this can also cause potential health problems. Patients are often on blood pressure medication for years at a time, leaving many in a difficult position where they cannot stop taking the drugs, but now face a chance of exposure to carcinogens as a result of their condition. As a result of these issues and their connection to the global drug, many in the U.S. have begun to advocate for more domestic drug manufacturing at home.
Although the FDA has not finished its investigations, multiple lawsuits have already been brought against the Zhejiang Huahai Pharmaceutical and Hetero Labs plants and their U.S. subsidiaries for failing to detect the carcinogenic elements in their blood pressure drugs.
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At Bertram & Graf, L.L.C., our Kansas City dangerous drug attorneys are committed to holding all relevant parties responsible for negligent manufacturing and distribution practices. We have represented clients affected by multiple defective medications, and are committed to fighting pharmaceutical companies and the medical establishment in court if necessary. From product liability to medical malpractice cases the individuals and entities entrusted with your healthcare should never be allowed to take advantage of you. Contact Bertram & Graf, L.L.C. today for a personal injury firm with a history of getting results, and start fighting for the compensation you deserve.
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