The People's Perspective on Medicine

Unbelievable! Yet Another Drug Recall | Amlodipine Plus Valsartan

The FDA has issued yet another drug recall because of contamination with a probable cancer causing chemical. It involves amlodipine plus valsartan. Enough!

OK, we admit it, we’re starting to sound like a cracked record when it comes to drug recalls. We apologize. It is really sad that we have to issue regular reports about FDA oversight and pharmaceutical contamination. A week ago we wrote an article titled “Another Day Another Losartan Recall | Can we Trust the FDA?”  It was about the latest losartan recall. The FDA noted that the drug company, Torrent Pharmaceuticals, recalled the blood pressure medicine losartan. Now, we have the distinct displeasure of reporting another big recall: Aurobindo is “voluntarily” recalling 80 lots of amlodipine plus valsartan tablets. Will it never end?

A LOT of Lots!

The Food and Drug Administration has issued another drug recall because of contamination with a probable carcinogen. This time it is for the combination pill containing amlodipine plus valsartan. This combo is prescribed for hypertension and heart failure.

The company is Aurobindo Pharma USA, Inc, a division of Aurobindo Pharma Limited of India. This recall falls on the heels of another recent recall for a related blood pressure pill called losartan. The recalled losartan was made by Torrent using an active pharmaceutical ingredient made by Hetero Labs, Ltd. Both companies are based in India.

There have been so many recalls of related medications that we have lost count. It all started in July of 2018. Here was our first People’s Pharmacy Health Alert:

Valsartan Blood Pressure Pills Recalled Over Cancer Concerns

The problem is that the manufacturing process for the active pharmaceutical ingredients of losartan, valsartan and irbesartan appears to result in contamination with N-nitroso-di-ethylamine (NDEA) and N-nitroso-di-methylamine (NDMA).

Aurobindo Recall of Amlodipine plus Valsartan

Aurobindo is recalling 80 lots of this combination medication. (That’s a lot of pills.) Here is a link to the FDA’s Dec. 31, 2018 announcement with a list of all the lots that have been recalled.

Please keep in mind that there can be many bottles in a lot. The FDA rarely, if ever, actually acknowledges how many pills are involved in any given recall. It could be hundreds, thousands, tens of thousands or even millions of pills. The FDA does not require manufacturers to be totally transparent with their “voluntary” recalls.

FDA Language Drives Us Nuts!

Here is what the FDA says in its official release about the amlodipine plus valsartan recall:

“Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.”

Let’s analyze the FDA’s message. On the one hand the FDA is saying that the Aurobindo amlodipine plus valsartan pills are contaminated with “trace amounts of an unexpected impurity.” That makes it seem as if there is so little unpleasantness that we should not bother our pretty little heads.

The FDA goes on to say that this “impurity,” though a “probable human carcinogen,” is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The implication is that NDEA is not such a big deal. After all, it’s found in food and water.

Just because thousands of people may have been swallowing a probable carcinogen for days, weeks, months or years is nothing to be too concerned about…even though the drugs are being recalled.

Then the FDA says:

“To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to the recall.”

Again, the FDA’s message seems to be, don’t worry, be happy. Of course no one would report cancer to Aurobindo. For one thing, the recall was just issued. Cancer takes years to develop.

It is unlikely that we will ever find out how the contamination of valsartan, irbesartan or losartan has affected anyone’s risk developing cancer. We would be astonished if the FDA required generic drug companies to do any epidemiology to try and detect a cancer signal.

The FDA seems not to know what to do about drugs that have a potential cancer risk. Here is an article we have written on this topic:

FDA Stance on Drugs & Cancer is Confusing

The Final FDA Message:

The Food and Drug Administration does its best to reassure patients taking amlodipine plus valsartan. The agency tells them that they:

“should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.”

Are there ARB (Angiotensin Receptor Blocker) Shortages?

With lots of lots of valsartan, losartan, irbesartan and combination pills like amlodipine plus valsartan recalled, there may be shortages. Here is the link to FDA Drug Shortages.

You will find a report that many valsartan products are “currently in shortage.” If you have been taking valsartan, you may need to ask your doctor to consider a different blood pressure medication. Check with your pharmacist to see whether there are shortages.

Reader Reactions To Drug Recalls:

Bob in South Carolina is worried about foreign-made drugs:

“When is this country going to wise up and stop buying drugs from foreign countries? I am on losartan. So far my product hasn’t been recalled. Is that because there isn’t a problem or because there aren’t enough resources to check out the company?”

Kathy in Howell, NJ, shared her concerns. We will never be able to answer her implied question.

“I took valsartan for over three years. I currently have lung nodules that have been followed for two years. I’d like to know just what this drug causes, as far as damage to an organ system., etc. I’m not a smoker and never have been. I just hope my nodules aren’t related to having taken this medicine.”

Gale in South Carolina expresses a view we have heard from others:

“This is so disturbing on many levels. As a volunteer provider at a free clinic for the uninsured, our best resource for medications for our patients is an organization that must rely on generics in order to provide the most medication to the most people. As a patient, it is difficult to trust generics, and yet name brand medication is wildly expensive. Profit margin over people’s health is a persistent travesty.”

Share your own thoughts about the recent drug recalls in the comment section below:

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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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I think we need to stop having the drugs made overseas. This is not acceptable to find our drugs being contaminated. You think you are doing good by taking what the doctor prescribes for you but then you end up finding the drugs are contaminated. I personally do not take generics any more. I will pay the full price for the brand name, which is what I am doing. Perhaps going on the cheap side of medications was a big mistake. I would rather pay more if I knew the drug was not contaminated with cancer-causing items. The generic for me did not lower my blood pressure like the brand name did. It also irritated me so I had to stop taking them. Once back on the brand name my blood pressure dropped. Too many bad fillers in the generics, and we have just found that out. It is time to think of safety and not the dollars $$$!

My big chain pharmacy said they have not been notified of this recall.

I have recently lost a significant amount of weight, and my blood pressure has come way down to an almost-normal level, and I am continuing to lose more weight. Since I have already had cancer twice I am choosing to get healthy naturally and to no longer take Amlodipine or any other blood pressure medication.

We need to stop buying drugs manufactured in India and China. My husband and I have done extensive research on drug manufacturers being cited by the FDA. The latest was Aurobindo. They were cited because the drugs had impurities in them, the people handling them didn’t know what they were doing, and they didn’t properly measure the ingredients, The report said they were not properly trained. The same citation showed that the containers were dirty and the facility had rodent and bird droppings. Most people don’t even know where their drugs come from. The pill bottle that we received from the pharmacy does not have the country or origin. The original pharmacy bottle does however. You should ask your pharmacist where the drug was manufactured – not the distributor location.

I have taken Amlodipine Bisolate for over a year. Should I be worried?

No. The problem is not the amlodipine, but rather the valsartan in this combination drug.

This whole scenario on the way drugs are manufacted has been puzzling me for years. Suppossecly, generics were created because brand name drugs cost too much. Seems to me, if the brand name drugs cost less, brand name companies would make more money because there would be no reason for generic drugs.

The way drugs are manufacted is just unbelievable. I think all the government’s in the world should get together and stop this madness.

How did we, the richest nation on the planet, come to this? Why did big pharma have to take their factories to India, China, Mexico, and only God knows where in order to secure huge profit margins?
We can’t even purchase decent medications from our Canadian neighbors at a fair cost.
And who are the politicians who cater to big pharma and underfund the FDA?

I have been taking both generic Amlodipine and Atenolol for years and have suffered from peripheral neuropathy. Had vascular surgery in early October and still suffering with leg pain.
Is it the medication? Who knows? Doctors say, “just keep taking it” and offer more pills to relieve the pain.

I am a Cancer Data Analyst. In the health system data set I work with, I’ve noticed about 84% of 2017 cancer cases are people with hypertension & taking drugs for it.

I know there is a LOT wrong with drawing ANY conclusion on this observation. But it can’t be good for cancer patients to take maintenance medicines that contain carcinogens.

I’ve elected to take the branded Edarbi. It is nearly $200 per month but worth it not to worry.

Your article makes it sound as if it were the FDA that wrote the recall notice. It did not; the wording was Aurobindo’s verbatim.
The FDA’s website that contains the recall notice states:

“When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.”

So your implied criticism of the FDA for the vagueness of the recall notice would seem to be somewhat unfair.

My Pharmacist says my torrent made losartan is not included in the recalled lots.
How can a drug that is made with the same recipe have some contaminated lots and some not?
I’ve been taking losartan and amlodipine for 10 years.

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