The People's Perspective on Medicine

A New Carcinogen Found in BP Meds | More ARB Recalls!

There are new ARB recalls. Camber and Torrent Pharma companies are recalling large lots of losartan. How did this happen? A new carcinogen rears its head!
Recall stamp illustration isolated on white background.

How many times have we said, Not Again? We are, sadly, referring to ARB recalls. ARBs are short for angiotensin receptor blockers. They treat high blood pressure. Basically, it boils down to another week, another drug recall. This time there were two companies involved and a LOT of lots! The FDA reported on March 1, 2019 that 87 lots of losartan from Camber Pharmaceuticals had a new impurity, NMBA. It is a “potential human carcinogen.”

On the same day, the FDA also announced that Torrent pharmaceuticals Limited is recalling 60 lots of losartan and 54 lots of losartan plus hydrochlorothiazide.

How Many Pills Are Involved in the ARB Recalls?

When we write that 87 lots from Camber and 114 lots from Torrent are being recalled, we don’t mean bottles. Goodness knows how many bottles are involved. There may be hundreds, or even thousands of bottles involved in this recent recall.

It’s even more mysterious how many pills are included in these ARB recalls. Many of the Camber and Torrent lots contain bottles with 1000 pills.

How Long Has This Been Going On?

Many lots of ARB blood pressure drugs including losartan, valsartan and irbesartan have been recalled over the past eight months. These medicines were contaminated with potential carcinogens known as NDMA and NDEA.

The recent ARB recalls involve an entirely new contaminant just identified as N-nitroso-N-methyl-4-aminobutyric acid, or NMBA. It too is a suspected carcinogen. All three of these nitrosamine contaminants are apparently created as a result of the manufacturing process.

How Did This Happen?

Companies have made changes to the process and the reagents used. Some people have speculated this has been as a result of an effort to increase the yield of the pharmaceuticals. FDA Commissioner Gottlieb stated:

“The FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API [active pharmaceutical ingredient], and may also result from the reuse of materials, such as solvents.

“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable.

“We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products. The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future.”

Did You Miss a Key Sentence?

FDA Commissioner, Scott Gottlieb, said something quite scary:

“…and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products.”

The FDA rarely raises a concern unless they suspect some bad news coming down the road. Usually the FDA tries its best to reassure patients, physicians and pharmacists.

At the risk of sounding a premature alarm, we fear another shoe is likely to drop for ARBs other than irbesartan, losartan and valsartan. That could mean an entire class of BP drugs could be affected by these manufacturing “glitches.” It could mean more ARB recalls.

Should We Learn to Love Carcinogens?

One reader of our articles about ARB Recalls spanked us for scaring people:

“Dear Joe Graedon:

1. Carcinogens are everywhere. We are exposed daily. Mostly our body takes care of them.

2. In what is presented, there is no mention of dose level. The dose makes the poison.

3. Analytical chemistry can easily detect very low levels, ppb; levels that are well within the body’s capacity to deal with.

4. Chemistry and production is science and technology. The same sorts of problems (if there really is a problem) can happen anywhere. China, US, Israel, etc. If essentially all production has moved to China, then it is no wonder that problems (if there are problems) will show up there.

5. IARC [International Agency for Research on Cancer] calls every think [sic] a carcinogen of one sort or another. They do not take dose into account. They are fear mongers.

6. The FDA and others with knowledge need to take some responsibility for separating the reality from the fear mongering.

I think your article could have been more helpful.”

Should you wish to read the article this gentleman is referring to, here is a link.

Irbesartan Is Contaminated with Probable Cancer-Causing Compound!

What do you think About ARB Recalls?

Not worried about exposure to nitrosamine carcinogens, share your perspective below in the comment section. If you agree with FDA Commissioner Gottlieb that the “presence of such impurities in drug products is not acceptable” we would also like to hear from you.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Have the name brand versions been recalled? Are they still available?

I do not feel that you are fear mongering in your comments. I am very fearful about drugs made in China and India. I have a friend who worked for a chemical company had to go to many other countries where his companies drugs were made. He was either there to check on the process or solve a problem. Needless to say, problems were many. I take a thyroid medication and believe that different lots ,though the same stated strength, are not. Drugs made outside the oversight of the FDA, are suspect.

It seems to me that the FDA is often a day late in reporting problems. But I disagree with the writer who seems to think you are being an alarmist for bringing this to our attention. Yes, there are carcinogens in the environment to which we are exposed on a regular basis, but that is not the same as popping a pill (that may surely be cancer-causing) daily for months or years. I do not want to knowingly take such a drug to help another condition. Thank you for alerting us to the recall.

After my husband had a slight heart attack in June and needed a stent they put him on Losartan. After reading about Valsartan I knew that it would eventually affect all of them so I asked his cardiologist to change it. First he didn’t even know about any of the recalls and second he said there is no way they are going to ever correlate cancer and the drug so he suggested he stay on it.

I suggested to my husband to change doctors!

I have been notified that my losartin has been recalled and given a phone no. to call. Every time I call ‘the voice’ tells me lines are full and call back late afternoon or early evening. I try every afternoon and evening and get the same message. What else do I do and what are they going to tell me IF I ever get through?

Can I get a list of the BP medicines
That are recalls and my have carcinogen

These recalls are very worrisome to me because I have been On Telmisartan for several years and have been on Torrent brand. Is there a way to find out if the FDAis testing Telmisartan? On my Rx drug box it says Torrent pharmaceuticals is in India.

As regards the reader who criticized you for scaring people….

He states “Carcinogens are everywhere. We are exposed daily. Mostly our body takes care of them. … In what is presented, there is no mention of dose level. The dose makes the poison.”

This raises the question: Are there safe dose thresholds for carcinogens?

To answer this question, your readers may be interested in one perspective on this issue, an article titled “Thresholds of Genotoxic and Non-Genotoxic Carcinogens.” (Takehiko Nohmi, Toxicol Res. 2018 Oct; 34(4): 281–290).

From the Abstract….

“Exposure to chemical agents is an inevitable consequence of modern society; some of these agents are hazardous to human health. The effects of chemical carcinogens are of great concern in many countries, and international organizations, such as the World Health Organization, have established guidelines for the regulation of these chemicals.

“Carcinogens are currently categorized into two classes, genotoxic and non-genotoxic carcinogens, which are subject to different regulatory policies. Genotoxic carcinogens are chemicals that exert carcinogenicity via the induction of mutations. Owing to their DNA interaction properties, there is thought to be no safe exposure threshold or dose. Genotoxic carcinogens are regulated under the assumption that they pose a cancer risk for humans, even at very low doses.

“In contrast, non-genotoxic carcinogens, which induce cancer through mechanisms other than mutations, such as hormonal effects, cytotoxicity, cell proliferation, or epigenetic changes, are thought to have a safe exposure threshold or dose; thus, their use in society is permitted unless the exposure or intake level would exceed the threshold.”

From the Introduction…

“Genotoxic chemicals are substances that interact with DNA and may subsequently induce mutations. Owing to their DNA interaction properties, genotoxic chemicals are not considered to have a safe threshold or dose. Therefore, they are expected to impose genotoxic and carcinogenic risks on humans, even at very low concentrations.”

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