What is NDMA?
NDMA stands for N-NITROSODIMETHYLAMINE. It’s a nitrosamine that’s made as a by-product when we use chloramines as disinfectants of drinking water, manufacturing rubber and tire, tinning of meat and fish, among other processes.
When foods contain nitrites (such as bacon), which are added to prevent overgrowth of botulism toxin and to also add the pink color in meat, they form into NDMA in our bodies. The concentration of NDMA in the air is also dramatically elevated during grilling of these meats.
Exposure to NDMA can also be from inhaling cigarette smoke (a reason why second-hand smoke can be considered worse than smoking), eating cured meat, and drinking beer. When a person is exposed to NDMA, it can lead to liver damage, kidney damage, and cancer in lungs, pancreas, kidney….
At levels of 5 parts per million (ppm) or higher, NMDA can cause these side effects in animals.
And how much was the level of NDMA in valsartan that was found?
As much as 60 ppm.
China plays a major hand in manufacturing drugs for the US, among other countries. Being so far away, the FDA has a challenge in overseeing and checking up on ALL oversees manufacturers.
One day though, the FDA overcame the challenge and took a couple of it’s inspectors to Zhejiang Huahai Phamaceuticals, the 2ndbiggest pharmaceutical manufacturer in the world. The inspector was surprised by what he found. With old, rusting machines, and failures to investigate “unknown peaks” in charts that detect impurities.
There is a great arcticle that all pharmacists should read.
Although the FDA is a big agency, oversees drug manufacturing is bigger.
The FDA relies on the people that manufacturers and trusting that they will uphold it’s regulations. In this case, one Chinese pharmaceutical company took advantage of that trust.
Unfortunately, this is an ongoing battle. Here you’ll find a warning letter from the FDA to a Torrent manufacturing facility in India, dated October 8, 2019.
We’ve all run into that customer.
“ I only want the white one”
“ I only want MYLAN with my drugs”
“ I don’t want anything made in china”.
When the blood pressure medications started being recalled, I couldn’t help but feel guilty about how picky I though all these customers were. But maybe they were picky for a good reason.