The continuing barrage of recalls of losartan and other ARBs is causing quite a bit of trouble in the pharmacy world, with millions of dollars in recalled products and untold man-hours dealing with the logistics of a Class One recall. Although the latest round of recalls have been “voluntary” recalls initiated by the manufacturers, each recall that I have seen is being treated as a Class One recall by pharmacies.
In addition to scaring the bejeezus out of patients with letters and phone calls, news alerts, and the inevitable spread of misinformation, which I guess we call “Fake News” now, the recalls continue to roll out. Anyway, I thought I should dig into this. Back when I was fat and ugly, I was on losartan for a time and although I don’t plan on being that fat or ugly again, I still want to know the facts.
The FDA recently unveiled new testing methods for the three nitrosamines of most concern, NMBA, NDEA, and NDMA. The FDA has “acceptable” limits for these three suspected carcinogens set at less than 100 nanograms per day. A nanogram is a billionth of a gram! The FDA states, “The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that approximates a 1:100,000 cancer risk after 70 years exposure.” That’s one cancer for every 100,000 patients exposed for 70 years! Note that most carcinogens take decades to have apparent effect.
The thing is, these nitrosamines are not exclusive to pharmaceuticals. They are in our food, water and air too! For this discussion, I will try to focus on the three N-nitrosamines named above. These are notoriously found in cured meats, notably in super delicious crispy bacon (sigh), beer, (sigh), and even our water supply (double sigh). Before this gets too gloomy, here are some bright spots: Microwave cooking of bacon likely creates fewer nitrosamines, and most beer makers have adopted newer malt drying methods that reduce the amount of nitrosamines in their product.
NMDA has been studied most extensively of the three and has been demonstrated in factory discharges (constraints on which have recently been relaxed by the current administration), and detected in diesel exhaust. My point is that we have been and continue to be exposed to these chemicals. Even the FDA seems to acknowledge reality as it now “is temporarily not objecting to losartan with NMBA below 9.82 ppm remaining on the market,” which is considerably higher than the recall benchmark of 0.96 ppm.
With all that in mind, feel free to make your own decision based on this knowledge and after consulting your health care providers. Our current level of medical knowledge allows us to live longer. For many, that means cancer will appear eventually, if we live long enough. For others, it never appears at all. Until we unravel all the mysteries of life, death, and cancer, we are all left to make our own choices and live with the consequences.
Keep up with drug recalls here at this FDA page.