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BP Drug Irbesartan Recall Reveals Contaminant Catastrophes

Carcinogenic contaminants keep showing up in BP drugs like losartan and valsartan. The latest scandal involves an irbesartan recall. HELP!
BP Drug Irbesartan Recall Reveals Contaminant Catastrophes
Recall stamp illustration isolated on white background.

Not again! The FDA recently announced the recall of the blood pressure medication irbesartan. All batches of this BP medicine made by the Indian drug company Lupin are being pulled off pharmacy shelves. That also includes its irbesartan plus hydrochlorothiazide pills. This irbesartan recall is just the latest in a very long string of scandals involving medications for hypertension, heartburn, diabetes and smoking cessation. Will it never end?

The ARB Impurity Nightmare:

Irbesartan is referred to as an angiotensin receptor blocker or ARB for short. In the latest irbesartan recall, the problem involves a contaminant called N-nitrosoirbesartan. Nitroso compounds are considered probable carcinogens.

This is not the first time ARBs have been recalled because of contamination. Blood pressure medications such as valsartan and losartan have been recalled because of other nitrosamine impurities such as N-nitrosodimethylamine or NDMA. The irbesartan recall is just the latest fiasco. No one wants to swallow a likely carcinogen every day as part of a medication regimen.

Many Other Recalls:

We were among the first to report on the ARB contamination debacle. Here is a link to our take on the immensity of the problem just a few years ago:

Valsartan Recall Update: How Big Is The Problem?
You have doubtless read about the valsartan recall because of contamination. Could it be the biggest consumer recall in history? Will some people develop cancer as a result?

We consulted several experts about this scandal. One believed that the valsartan mess might have been the biggest pharmaceutical recall in history. We suspect that tens of millions of pills had to be destroyed because of carcinogen contamination. Sadly, the FDA never actually reveals how many pills are “voluntarily” recalled.

Last summer Health Canada recalled batches of valsartan, losartan and irbesartan because of azido impurities. Generic drug companies caught up in the recall included Teva, Sandoz and Sanofi. These have been major players in the generic drug marketplace.

The Chantix Recall:

Drug recalls have not been limited to blood pressure medications. Lest you think the irbesartan recall is unique, here is another recent contaminant controversy. Over the summer Pfizer announced that it was suspending world-wide distribution of the stop-smoking drug Chantix (varenicline). That was because of high levels of nitrosamine contamination.

All lots of Chantix distributed between May 2019 and September 2021 are now being recalled. The FDA is not advising patients to stop taking Chantix, however. Instead, the agency advises people taking the stop-smoking medication to consult their healthcare provider and ask about alternative approaches for quitting smoking.

Here is the company announcement from the FDA. Do you find it reassuring?

“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.”

The Zantac Disaster:

Another medication that has disappeared from pharmacy shelves because of contamination with a probable carcinogen is ranitidine. It was once sold under the brand name Zantac.

Ranitidine was found to have excess levels of NDMA, the same nitrosamine found in tainted blood pressure medications such as valsartan and losartan. When ranitidine was stored at high temperature or left for a long time in warehouses or on shelves, NDMA formed. You can read about the ranitidine recall at this link.

The Metformin Mess:

Batches of another medication, metformin, were also found to contain NDMA. It’s the most widely prescribed diabetes drug in the world. In theory, most metformin being sold today is no longer contaminated. You can learn more about the metformin recalls at this link:

More Metformin Recalls Distress Diabetes Patients
Have you lost count of metformin recalls? We have! Contaminated drugs continue to be pulled from the market during the pandemic. It’s a lot!

Zantac has been reformulated with a different acid-suppressing drug. Zantac 360 now contains famotidine instead of ranitidine. Want to learn more about this switcheroo and the big recall? Here is a link to the back story.

Readers React to Irbesartan Recall and other Contamination Catastrophes:

Bob describes a previous irbesartan recall challenge:

“After reading that irbesartan had also been found to be contaminated, I called my health care provider and prescription drug provider for more information. While discussing the specific lot numbers of the irbesartan/HCTZ bottles in my medicine cabinet, I was advised that none were among the recalled lots.

“Weeks later, my health care provider sent a letter stating that irbesartan distributed by the same pharmaceutical company which supplied my prescription had been recalled, so I phoned the distributor and discovered that one of the bottles containing the last 15 of the original 90 tablets was among the recalled lot numbers. Thank you very much!

“I had already taken 83% of the possibly contaminated pills, and they were offering to replace the remainder!!??? I’m pretty fed up with pharmaceutical companies enhancing their own profits by purchasing garbage when they should be manufacturing the drugs in the U.S., where FDA regulations and inspectors provide at least a semblance of safety for us.

“The CEOs earn (?) millions per year in many cases, while we struggle to pay for necessary prescription drugs manufactured under contaminated conditions. They should be in jail, or better yet, forced to swallow the same contamination found in their products. Shame!”

Nurse Ann is worried about cancer:

“I was switched from brand name Cozaar to valsartan. Mine was one of the ones on the recall list. Recently my uterine biospy showed hyperplasia and my gyn/oncologist recommended a complete hysterectomy, including ovaries and tubes. They are also telling me that just because the biopsy did not show a malignancy does not mean I don’t have cancer and they won’t know till they remove the organs and examine them. As a nurse for 30 years, who leads a healthy lifestyle, I could not be more upset. I blame the valsartan and find it to be more than a coincidence.”

Susan too is worried about cancer:

“I’ve been on valsartan for seven years and was diagnosed with kidney cancer in May. I underwent a partial nephrectomy in June. I’m very worried that 1) this drug caused this cancer as I do not have a family history of cancer and/or kidney cancer and 2) that another cancer may be developing due to this drug. How dare they change the manufacturing process without testing the product!”

Mitch on old irbesartan recall:

“I took the generic of valsartan from the Zhejiang Huahai Pharmaceutical Co., Ltd. for several years. I took it because that’s what my pharmacy stocked. And this was a major chain. I trusted them. This was my first mistake.

“Since that time, I have become a reluctant expert in Indian and Chinese generics, thanks in part to People’s Pharmacy, Katherine Eban’s book (Bottle of Lies), and my own research. What I have found is shocking. I was prescribed a replacement – irbesartan, and went to pick it up and found it was also made by Zhejiang Huahai. Yep, after all the news was out, including the ban on imports, several major pharmacy chains were selling their remaining supply from this company.

“The Irbesartan was recalled about a month or two later. Shocker. But I was aware it was made by them only after insisting to see the supplier’s bottle with the manufacturer on it. I refused it.

“I have tried to find the ‘cleanest’ generic out there for an ARB, but they keep getting recalled. I have called the FDA and spoken to their pharmacists. I have asked why one year later they still haven’t finished testing these drugs for ‘impurities.’ I have learned that there are now five (5) known impurities in the ARBs.

“We’re in trouble here. Doctors don’t seem to be concerned about this. Or, if they are concerned, they aren’t taking action. It baffles me. Hey AMA, get on it and make a difference by getting out ahead of this. I predict it will get worse before it gets better. Please everyone, learn how to research your drug manufacturers. Read their FDA warning letters. Ask yourself whether your pharmacy is working for you, or for your insurance company. Do it like your life depends on it.”

Share Your Thoughts:

Have you ever experienced a drug recall? What was it? Do you have confidence in the FDA’s ability to monitor the quality of your medications? We would love to get your perspective in the comment section below.

If you would like to learn more about “authorized” generics and reputable online Canadian pharmacies you may want to consider our eGuide to Saving Money on Medicine. It is available under the Health eGuides tab at this link.

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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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