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Just How Did Cancer-causing Nitrosamines End Up in Our Medications?

If you take medication for blood pressure or heart failure, chances are you have been affected by, or at least heard of, the recent recall of over 75 different generics of valsartan, losartan, and irbesartan and their combinations.

75 different generics? But how can so many different manufacturers be affected when the FDA strictly oversees good manufacturing practices?

Well the FDA, by their own admission, is slightly embarrassed. They pride themselves on their robust policies and procedures to guard against this kind of thing happening. But, in their defense, even a routine current good manufacturing practice inspection wouldn’t have picked up this issue. Instead, new guidance for manufacturers about how to evaluate the presence of genotoxic impurities issued in March 2018 uncovered what turned out to be a widespread problem. They’re still trying to uncover the root cause, but a bit of digging so far has suggested inadequate supervision leading to compromised quality control procedures were to blame.

Nitrosamines are chemical compounds that are produced when nitrites and amines combine in acidic place. This can be the human stomach; during heating or preserving; or, in this case, a laboratory during the manufacture of a drug. Historically, nitrosamines have been used as preservatives, fertilizers, to increase the shelf life of processed foods, or in the transport of fresh fish. Significant levels can be found in beer, fish, non-fat powdered milk, cured meats (primarily bacon and hot dogs) and preserved cheese. Both frying and high temperatures increase the formation of these compounds, most of which are carcinogenic. The nitrosamines found in the recalled drugs were N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) or N-Nitroso N-Methyl 4-aminobutyric acid (NMBA).

But if they are common in foods then what is the big issue with them being in drugs? The FDA believes their presence in drugs products is unacceptable, particularly when steps can be taken to ensure that they do not contaminate the manufacturing process at all. All the drugs recalled contained NDMA, NDEA, or NMBA levels above the acceptable intake limit. But reassuringly, the actual overall risk to individual patients is small, with an estimated 1 additional cancer case likely if 8000 people took the maximum dose of a contaminated valsartan product for four years.

Last week, the FDA approved a new generic valsartan to try and alleviate the current severe shortage of this medicine as a result of all the recent recalls. This one is guaranteed to be nitrosamines-free!

Posted: March 2019

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