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Thursday, September 12, 2019

Those Taking Valsartan Or Irbesartan Blood Pressure Medication Should Read This

Please follow the link shown below, to understand the extent of the problem discovered.  Blooomberg's article is extensive in coverage but deserves to be read by those affected directly or indirectly.  Check with your friends and relatives, who may take these drugs, and forward this article, along with the web-link.

Personally, my generic pills (Enalapril) are made in India, instead of China but I don't feel any better about that.  We often hear criticism about drugs fabricated in Canada, personally, I trust these Canadian drug companies more than all the others combined.  Unfortunately, some of these off-shore companies have branches in the US, and probably Canada, therefore, these drugs can still be bad, no matter where they were made.  It stands to reason, when the parent company is corrupt, their divisions located elsewhere will likely not be anymore ethical.

As Blomberg's article amply demonstrates, our regulators and the FDA inspection process are less than stellar; why did it take so long to discover this very serious problem, discussed below.  The manufacturer involved made cost-saving changes to its process in 2011, with serious adverse consequences for patients, using this drug.  Only in 2018 did the FDA go public, per the article referenced below.

"In July 2018 the FDA announced that NDMA had been found in the widely used blood-pressure medicine valsartan and started overseeing a recall of drugs from three companies. They’d all bought the active ingredient for their valsartan from Zhejiang Huahai Pharmaceutical Co., one of China’s biggest generic companies. The recall has since been expanded 51 times, to include two related drugs, irbesartan and losartan, made by at least 10 companies—some since 2014. Drugs sold to millions of people in 30 countries could be tainted.
Some of the contaminated valsartan contains as much as 17 micrograms of NDMA in a single pill. That’s equivalent to eating 48 pounds of bacon. The FDA estimates that for every 8,000 people who took the highest dose of contaminated valsartan daily for four years, there would be one additional occurrence of cancer. “We had to be honest about that, but it’s not a great message for the consumer,” says Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. “Throw a couple of lamb chops on the barbecue and you’d find nitrosamine after a good grilling. You have to put this in perspective.”You’d find nitrosamine—a category of carcinogen that includes NDMA—but you wouldn’t find 17 micrograms of it. European health regulators put the cancer risk from contaminated blood pressure medicines higher: They estimate that one out of every 3,390 people could become sick."

https://www.bloomberg.com/news/features/2019-09-12/how-carcinogen-tainted-generic-drug-valsartan-got-past-the-fda

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