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Irbesartan Is Contaminated with Probable Cancer-Causing Compound!

Millions of ARB prescriptions are taken each year to control blood pressure. Batches of valsartan were recalled. Now some irbesartan is contaminated. Help!

We are getting very tired of saying “Not Again!” Sadly, though, this has become a surprisingly familiar refrain here at The People’s Pharmacy. This time it is another ARB (angiotensin receptor blocker). Some irbesartan is contaminated. We don’t know how many pills are affected. It almost doesn’t matter. We are fed up with foreign-made drugs showing up with carcinogen contamination. What about you?

First Valsartan Now Irbesartan is Contaminated:

It all started around July 5, 2018. We discovered that the European Medicines Agency (EMA) announced that a Chinese-made version of the blood pressure drug valsartan (Diovan) was contaminated with N-nitrosodimethylamine or NDMA. This probable carcinogen was found in a number of valsartan products. Read our special health alert here.

On July 13, 2018 the FDA took action too. Since then there have been frequent announcements of additional valsartan products that were contaminated. Find the list of affected products here.

The total number of contaminated pills is mind blowing. Here is a link to many of the manufacturers that got into trouble with their valsartan. Now we have learned that a related drug, Irbesartan is contaminated too.

Irbesartan is Contaminated: How Ironical

Like valsartan, irbesartan (Avapro) is an ARB (angiotensin receptor blocker). Many people taking valsartan to control their blood pressure were switched to irbesartan when the FDA announced that valsartan from several different companies had been contaminated with a carcinogen.

The New FDA Announcement that Irbesartan is Contaminated:

“ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API [active pharmaceutical ingredient] Irbesartan, USP manufactured by Aurobindo Pharma Limited.”

Companies that sold irbesartan include Westminster Pharmaceuticals and Golden State Medical Supply, Inc. Consumers are urged to examine their tablets and consult their pharmacists to determine if their irbesartan is among the lots being recalled.

Add Losartan to the List:

The most recent recall (February 2019) involves the blood pressure drug losartan, made by Hetero Laboratories and distributed by Macleods Pharmaceuticals Limited. Both companies are headquartered in India.

Are you Getting Tired of Drug Recalls?

It’s bad enough when a car company issues a recall because of a problem with ignition switches or air bags. We are even more alarmed when we are told that millions of people may have been exposed to a carcinogen in their medicines. Swallowing a potentially cancer-causing chemical for years is unforgivable.

It will be virtually impossible to tell whether exposure to one of the recalled drugs is responsible for cancer. Many patients will wonder as this reader did.

Nancy in Georgia would like to know if this is a coincidence:

“I have been on (the recalled) valsartan for several years. I had to call my pharmacy about the recall. I knew before they did. They had to check. They exchanged my pills for ones made in the US. And, now I have pre-cancerous cells in my breast and will be having a lumpectomy. Coincidence?”

What About Other Recalls?

Shari in North Carolina reports a concern about hydrochlorothiazide:

“I took my husband’s prescription for hydrochlorothiazide in to the Walgreen’s where I purchased it. The pharmacist said his was in the recalled batch according to this information put out by the FDA. She gave me the number to call for Accord.

“When I called, the person I talked with said ours was not the pill that was recalled-so the FDA information was incorrect. She said the recalled pill is yellow and has an AB on it. This is very confusing and does not make us trust the information that is coming from the FDA-nor from the pharmacist!”

Mary is also confused:

“I too called that number, and the lady was adamant that my lot was safe and that the recall was the yellow one, which does not fit the description of the recall. This sounds dangerous enough to confer with a physician for an alternative or nothing.”

People’s Pharmacy Perspective:

Making medicines is not like making widgets. If a potato peeler or a tennis ball is imperfect it is not life threatening. If a medicine is contaminated or contains the wrong dose, it can be life threatening.

Perhaps it is time for the FDA to tighten its monitoring process. If a drug company makes a mistake, we think the executives should be held accountable.

What do you think about all these recalls? Share your thoughts in the comment section below.

Updated 2/28/19

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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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