Not again! Another nitrosamine scare has just been announced for one of the most popular drugs in the pharmacy. Metformin is the number one most prescribed diabetes drugs in the U.S., if not in the world. At last count, 18 million citizens filled 89 million prescriptions for metformin last year. But word from abroad, and now from the FDA, suggests that there is a concern about metformin and nitrosamines.
What Are Nitrosamines?
For the last year and a half, you have been reading about blood pressure medicines that have been contaminated with nitrosamines. Millions, perhaps tens of millions, of pills have been recalled. We’re talking about drugs like irbesartan, losartan and valsartan. Then there was the ranitidine (Zantac) recall. That was also because of nitrosamines. We have lost count of how many recalls have occurred over the last year or so.
Nitrosamines are potent cancer causing chemicals. In recent news stories journalists have taken to calling compounds like NDMA “probable carcinogens.” We think that is way too cautious. Here is what the American Chemical Society stated about nitrosamines in 1979:
“Among carcinogens the N-nitroso compounds are the most broadly acting and among the most potent.”
N-nitroso compounds include nitrosamines. Animal studies demonstrate that most nitrosamines induce tumors in rodents. We have no reason to suspect that humans are immune.
The FDA keeps reassuring the public that the levels of nitrosamines in drugs like ranitidine or metformin are low and not worrisome. The trouble is that there have been no well-controlled human trials to determine if that is really the case. Such studies would cost hundreds of millions of dollars and take decades to complete. We may never know how many people were harmed by nitrosamines in losartan, valsartan or ranitidine. Most people would prefer not to swallow any dose of nitrosamines with their medicine every day for years.
Metformin and Nitrosamines?
The breaking news about metformin and nitrosamines came in just as we were completing an article about how the FDA Embraces Generic Drugs from India Despite Quality Problems. We have provided detailed information about the metformin and nitrosamines controversy in that article. Rather than repeating everything here, we suggest you go to that article in the newsletter for all the details. Here is a link.
The executive summary is as follows:
Valisure, a pharmacy in New Haven, CT. has been testing all the pharmaceuticals it sells for quality, purity and nitrosamines. It was Valisure that notified the FDA there was a problem with ranitidine. We spoke with the CEO this afternoon and he alerted us to the fact that his testing lab detected nitrosamines in samples of metformin from abroad.
In addition, the FDA put out a statement Thursday evening that:
“While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time.”
Are you reassured? Once again the FDA seems to be moving very cautiously, just as it did with the ranitidine and valsartan nitrosamine recalls. You can read more about that process at this link:
We would not be surprised to learn in a week or two or three that the FDA has discovered metformin and nitrosamines are a concern. The Food and Drug Administration has a very hard time admitting that it ever makes mistakes. If drugs are found to be contaminated with impurities, it reflects badly on the agency. We keep being reassured that the United States has the best and safest drugs in the world. After so many recalls, we are beginning to wonder if the FDA really has its monitoring act together.
Read more about the latest breaking health news regarding metformin and nitrosamines at this link. You will learn about how you can have your pills tested. You will get an overview of the FDA position on metformin and nitrosamines. Do not stop taking metformin suddenly! Controlling blood sugar is essential.
Are you getting fed up with all the recalls? Share your thoughts in the comment section below.