The People's Perspective on Medicine

Another Week Another Losartan Recall | Will It Ever End?

After nine months the recall of contaminated generic BP drugs continues. Now it's a losartan recall from Teva. Why hasn't the FDA cleaned up this mess?

OK, we admit that we are beyond fed up. There have been so many blood pressure drug recalls since last July that we have totally lost count. It was only about a week ago that we wrote about a recall of 104 lots of losartan by India’s Torrent Pharmaceutical company. That involved over one million bottles of blood pressure meds. Some of those bottles contained 1,000 pills. This week one of the largest generic drug manufacturers in the world, Teva Pharmaceuticals, also issued a losartan recall. The company announced it is recalling 35 lots of tainted losartan. Many of the bottles in these lots contain 1,000 pills.

The Losartan Recall now totals 368 Lots:

The FDA rarely reveals how many pills are recalled. We estimate that tens of millions of losartan pills have been pulled off the market over the last nine months. And that doesn’t count all the recalls of contaminated irbesartan and valsartan. It is hardly surprising that there are now shortages of these angiogensin receptor blocker (ARB) blood pressure medications.

The original recall of valsartan last July was because the active pharmaceutical ingredient (API) made in China by the Zheijiang Huahai Pharmaceutical Company was contaminated with a nitrosamine compound. It is a probable carcinogen. Since then the FDA has announced that the Indian company, Hetero Labs, made contaminated losartan. It apparently sold the tainted API to both Torrent and Teva.

Are Your Pills In the Latest Losartan Recall?

Many of the lots of losartan sold by both Torrent and Teva involved bottles containing 1000 pills. That means your pharmacist would have to take tablets from a big bottle and put them in a little amber pharmacy bottle.

The FDA issues a notification of “Recalls, Market Withdrawals, & Safety Alerts.” Here is the latest company announcement from Teva Pharmaceuticals USA, Inc about the losartan recall.  If you go to that link published on the FDA’s website on April 29, 2019 you will find all the lot numbers involved in the losartan recall. Will that information do you any good?

We are willing to bet you three People’s Pharmacy bottles of aluminum-free MoM deodorant that you will not find a lot number on the label of your amber pill bottle. That’s because few, if any, pharmacies print lot numbers on pharmacy-dispensed amber bottles. If, on the other hand, you get a bottle of 30 or 90 pills in the manufacturer’s original bottle, you will find a lot number.

Does this make sense? Of course not. Every bottle of pills dispensed in the United States should have a lot number and a true expiration date. Without the lot number on your bottle you have no way of knowing whether your pills are part of the recent losartan recall.

We think it would also be a good idea to include country of origin as well. Where was the API (active pharmaceutical ingredient) made and where were the pills formulated? If the losartan came from China and the pills were made in India, we want to know that information. Don’t you?

How Risky are the Nitrosamines in the ARB Recalls?

According to the ACS Symposium Series from the American Chemical Society (June 20, 1979):

“Among carcinogens the N-nitroso compounds are the most broadly acting and among the most potent. They comprise the directly acting nitrosamides and the systemically acting nitrosamines, which require enzymic activation for their carcinogenic action…More than a hundred N-nitroso compounds have been tested for carcinogenic activity and most of them have induced tumors in rats; a much smaller number has been tested in hamsters, mice or guinea pigs and, again, most of those tested have been carcinogenic.”

The FDA has done its best to downplay the risk. Here is the FDA’s statement about one of the nitrosamine contaminants:

“FDA estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people.”

In its losartan recall announcement, Teva Pharmaceuticals states:

“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.”

Do you find that statement reassuring? In truth, no one really knows how likely the nitrosamine-containing blood pressure pills will cause cancer. This is a gigantic experiment that has gone on for four years.

Generic drug companies often say something like this about the spate of recalls:

“To date, [this drug company] has not received any reports of adverse events related to this recall.”

It can take many years, if not decades, for cancer to develop. We doubt that the FDA or any of the generic drug companies in question will be sponsoring large-scale epidemiological studies to determine the actual number of ARB-related cancers caused by nitrosamine contamination.

Why do the recalls continue? By now, we would have assumed that after nine months the FDA would have cleaned up this mess. The latest losartan recall suggests otherwise.

Share your own thoughts about tainted drugs in the comment section below. And be sure to listen to our live radio show this Saturday (7:00 am from our host station WUNC-FM) or download the podcast on Monday. In it we discuss tainted drugs and quality control. A whistle blower tells his story about an Indian generic drug company and a former FDA medical officer shares his concerns about the agency he used to work for.

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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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Thank you for highlighting the sad truth of our pharmaceutical system. If patients knew the degree of lax oversight, many would stop taking their meds. Most bottles in my pharmacy do not list the country of manufacture.

I just received the 4th Losartan recall letter in 6 months from CVS. Yes, the letter has the lot numbers on it and no, the prescription bottle does not list lot numbers. When you take your bottle back to CVS they have no way of determining whether your prescription is contaminated or not because they keep no records on who got what lot number. All they can do is look at the bottles they have on the shelf to see if the bad lot numbers are there. Of course, they should have gotten rid of those bad lots by the time the letter goes out. So the kid at the counter just looks at you with a blank face and says “sorry”. It is hard to fathom how CVS keeps selling drug from manufacturers they know have a history of selling cancer causing contaminated drugs. Who does one contact at CVS and the FDA about this? They are purposely allowing foreign companies to poison American citizens.

The FDA seems to have lost their concern for the little guy they’re supposed to be protecting. I called my pharmacy and asked how would I know if my losartan script was part of the recalls. They assured me that they contact by phone each customer who might be effected. So I’m relying on my pharmacy.

No way can I afford to pay cash for brand name drugs that my insurance will not cover. My Telmisartan is made by Accord, and the box says the company is from India…but no way of knowing that the drug actually came from China.

The drug is listed on the FDA’s website as having a small amount of NDMA but no lots are listed. I hate to switch drugs because this one works well.

I was taken off losartan, because I developed a rash around my mouth, he thinks due to this drug. From the looks of it, we should be off all scripts.

How can we as consumers make the proper agencies know that we want these foreign entities who manufacture our drugs to come under the same scrutiny as any other USA company. India has long been known as having highly intelligent, educated people who have important positions in drug companies. I take hypertensive medication (although not Losartan) daily and ASSUME it is safe for me to ingest. As an American, and a more mature American I am distressed that daily, my friends are taking lethal drugs that are supposed to help them.
I’ve joined multiple groups over the years who have great intentions, but never manage to get any satisfaction by petitioning or sending complaints.

I have been using Losartan 100 mg for many years and have not heard one peep from my doctor about the recalls. I am 85 so I imagine she is unconcerned about possible cancer. Really pretty scary when u get old.

We pay taxes to finance the FDA. The mission of the FDA is to ensure the efficacy and safety of drugs for us. When we have reached the point, as we apparently have, that we need to backstop the FDA ourselves, the question has to be asked, “When do the congressional oversight hearings begin?”

You know what? I took matters into my own hands two years ago when I got fed up with prescriptions and doctors. I went to the chiropractor, had my atlas nerve adjusted which brought my BP down immediately and unclogged my ear. I have been drug-free, not even an aspirin in over two years and have never felt better in by life. BTW, I’m 75 years old.

Having been made very ill by Lorsartan made by Teva several years ago, I am not surprised by this recall or by the FDA’s failure to clean up this product. It seems to be about the money.

What recourse do we, the general public, have?

I received notification from my Pharmacy long after I had taken all the medication.

Are they responsible for my cancer treatment, if needed, or am I on my on?

How long does it take to have adverse effects?

Are we respected any more than the Lab Rats used in experiments?

Will it ever end? Not as long as we allow most of our generic drugs to be made overseas with ingredients from places like China. Most people won’t give their pets dog treats from China yet they put prescription drugs in their bodies without a second thought. Thanks to the pharmaceutical companies who have pushed drugs for decades, many Americans are taking 6 or more medications daily. And I won’t even get into the statin fiasco where doctors are pushing them on most men over 50 and almost everyone over 60.

Somebody needs to get fired who’s in charge of this at the FDA. They aren’t doing their job.

Is Diovan, the brand, also included in this recall?

My Losartan pills were recalled by Express Scripts, and I had to go to my doctor to get a Rx for a different drug. It seems we cannot trust medications that are made in places like India and China. This should not be allowed. Why can’t our medicine be made in this country?

Last week OptumRx dispensed to me 90 Losartan Tab 50mg made by Aurobindo, Lot# OK5018094-A

It would really be helpful if you would identify all the drugs involved by name.

I get my Rx from a large US mail delivery service. I would like to have the lot & manufacturer on my individual bottles of Rx. This makes sense. Easy to scan the container and have MY label printed with this important information. FDA should make this happen!

This is beyond frustrating and infuriating. My elderly parents take Losartan – their worthless GP took months to change their med after the Valsartan recall, and did so only because I kept pushing my mom about the topic. She no doubt will take months again. Even as bad as she is, my parents, at 83 and 90, will not change doctors. We need more geriatricians.

I think the US needs to increase funding to the FDA with the specific instructions to improve prescription safety and oversight! Yes, I definitely agree with requiring medications to list the lot number, origin country of active pharmaceutical ingredient, country of formulation.

I would appreciate information from you as to how the general public can best put pressure on our government to improve this important system. Letters/calls to our congressman, the FDA (whom?), etc?

For a civilized country with a watchdog FDA to not oversee medications is abominable.

Just wondering if there had been any recalls on the combination Losartan Potassium and Hydrochlorothiazide.

I take 5 prescription medications; 4 are generic. FDA enforcement of generic drug quality standards is ineffective at best and almost fraud-like at worst. I do not trust the quality of my generics, but have limited options, if any. Sad

I was on Valsartan for many years, and my blood pressure was under great control. Since the recalls started I have been switched to Urbesartan and Olmesartan, and neither of those was able to get my blood pressure under control. My doctor has just switched me back to Valsartan this week. He said the pharmaceutical company has corrected the problem with Valsartan. I only hope he is correct. I do not have faith in any meds coming from China or India. So I will keep my fingers crossed and wait for the next recall! I am fortunate that my pharmacy dispenses my 90 day supply in the manufacturer’s bottle so I have the necessary information to check.

I have been taking Losartan-Hctz 100-25 for about ten years. To date I have received two letters from Walgreen’s stating that I was given pills from these recalled lots. However, I have not been refilling my prescriptions at Walgreen’s for at least three years, when my insurance company switched to CVS. Of course that means I’ve taken all these pills! The letter says if I don’t have the pills anymore “there is nothing I need to do.” Really?! I am very concerned and do not trust the pharmaceutical industry or the FDA at all.

There is not time to do a study. All losarton products should be removed. I take it. It scares me to think I could get cancer from this drug. So far, my version has not been recalled. I will have to check if this latest recall involves my brand.

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