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Posted By: Lawrence Herman, MPA, PA-C
October 11, 2019
In July 2018, the FDA announced that a known carcinogen, called N-Nitrosodiumdimethylamine, or NDMA, had been found in valsartan manufactured by Zhejiang Huahai Pharmaceutical Company, one of China's largest generic manufacturers. The FDA has now expanded this notification more than 50 times to include irbesartan, losartan, and H-2 blockers sold over the counter.
How has NDMA tainted so many of the generics sold, and even manufactured, in the United States?
Currently, more than 90% of drugs prescribed in the US are generics. They are inexpensive but reach the market with far less scrutiny. Eighty percent of the generics or active pharmaceutical ingredients (APIs) for all drugs are made in China or India. Right now, the FDA has little to no oversight of manufacturing and importation inspections. Between 2008 and 2014, the FDA had three offices in China—Shanghai, Guangzhou, and Beijing—to facilitate regular inspections. As of 2014, only the Beijing office remained. In a May 2017 inspection of Huahai, FDA personnel found a plethora of problems including, but not limited to, aging, rusty equipment, testing anomalies, and signs of product contamination. The FDA didn't stop production or reprimand Huahai; they simply expected them to fix the problems. But Huahai didn't.
Of course, generics and APIs continue to be manufactured and shipped, and the APIs are incorporated into other generics—some manufactured within the US. The FDA admits that at our borders, only 1% of products coming from overseas are inspected for impurities or potency before being released into this country. Only now are we discovering how widespread the contamination may be. I would argue that we haven't even gotten to the bottom of things, which is scary.
While some would argue that this isn't such a big deal, the data say that for every 8,000 people who took the highest dose of the most contaminated valsartan daily for four years, there would be a single additional occurrence of cancer. Well, I certainly don't want that unnecessary cancer diagnosis to be in one of my patients.
But this results in another consequence that is not trivial: if a medicine I prescribe isn't perceived to be safe, it adds one more reason for my patient not to take it. We already have enough trouble with medication adherence without adding yet another barrier.
- Edney A, Befield S, Yu E. Carcinogens have infiltrated the generic drug supply in the US. www.bloomberg.com/news/features/2019-09-12/how-carcinogen-tainted-generic-drug-valsartan-got-past-the-fda. Accessed Oct 10, 2019.