The People's Perspective on Medicine

Another ARB Recall Translates into Bad BP Control

Have you lost count of all the blood pressure medicine recalls? Sorry, here is yet another ARB recall. This time it is for losartan from Legacy. Enough!

Yup, you guessed it. The FDA has issued another ARB recall. This time it is for losartan…again. On March 15, 2019 and again on March 19, 2019 the FDA announced that Legacy Pharmaceutical Packaging, LLC, was recalling 25 mg, 50 mg and 100 mg lots of losartan because of the impurity NMBA (N-Nitroso N-Methyl 4-amino butyric acid). This probable carcinogen is just the latest nitrosamine that has been found in angiotensin receptor blockers (ARBs) that treat high blood pressure. Other drugs in this class include valsartan and Irbesartan. One reader has shared his problems with yet another ARB recall.

ARB Recall Makes it Harder to Control Blood Pressure:

Q. I am very concerned about all the recalls of blood pressure pills. When valsartan was first recalled, my doctor put me on losartan. Before long, that was also recalled. In the meantime, my blood pressure was not well controlled.

I’m back on valsartan now, but I have no confidence that it is safe to take it. I can’t afford the brand name, Diovan, because it is so expensive. I guess I have an unacceptable choice: Do I die from cancer or a heart attack or stroke?

An Unpleasant Choice:

A. Since July millions of blood pressure pills have been recalled because of nitrosamine impurities. The drugs include irbesartan, losartan and valsartan. We are not totally convinced that there won’t be a different ARB recall down the road.

According to the FDA, the risk of cancer is very low even though the recalled medicines have been contaminated with suspected carcinogens for four years or longer. The company announcement posted on the FDA’s website states:

“NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.”

Right. How would anyone even know whether a particular cancer was related to a particular recall, especially since it can take many years for cancer to develop. The FDA says the risk is low. That may be true, but most people would prefer to avoid potential cancer-causing chemicals in their medicines. We will likely never know how many people developed cancer as a result of the widespread contamination.

Doctors Weigh In on the ARB Recall:

A perspective published in the New England Journal of Medicine (March 13, 2019) points out that doctors may find it challenging to switch patients from one medication such as valsartan to another, such as losartan.  There aren’t good studies to guide them on how to adjust the dosages.

The average retail price for a month’s supply of brand name Diovan (160 mg) is $320, according to GoodRx.com. That organization offers coupons that can lower the price to $260.

Canadian online pharmacies offer Diovan at around $45 for a four-week supply. There have been no reports of contamination with this brand. You can learn more about Canadian online pharmacies in our eGuide to Saving Money on Medicines.

Are you fed up with another ARB recall. Share your thoughts 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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Cipro and Levaquin have destroyed my quality of life. Feet are numb yet frozen. Can’t sleep without a heating pad. Have fallen twice :Absolutely MUST pay attention to every step. Terrible pain in legs and shooting pains at night. Have to walk the floor – haven’t had a good night’s sleep since I can remember. Originally took the drugs for repeated bouts of pneumonia. I’ll take pneumonia any day before I’ll stoop to these killer drugs. Just sayin’.

Sorry, what is an ARB?

What are we to do, die ?

There are no lot numbers and no ID on my meds. Like most people, mine arrive at the pharmacy and are repackaged. My pharmacist told that makes it impossible to know exactly the manufacturer or lot number. I asked why can’t they get programming that adds a scan of the original bottle and is stored in my information. It wouldn’t be necessary to have it on the bottle given to me, but it should be readily available if I call. If you have meds coming from everywhere, then tracking becomes even more important. A frozen peas recall resulted in a call to my house because my shopper card indicated I had bought the affected brand – but you can’t track where and when my drugs are made? Funny, telling me “You should be OK” does NOT fill me with confidence. Our system is broken, completely.

I was also told by my pharmacist that my Losartan was not on the recall list. However, the pharmacist cannot know that: how can they remember which bottle they filled your particular prescription from? The pharmacist does NOT know what lot number your prescriptions were filled from. It would be so simple to put the lot numbers back on our prescription bottles as they did in the past. Is that too much trouble to keep their customers safe ??????????

I have had two drug reactions since I have been on first, Valsartan, and second, Olmesartan. The first drug I reacted to was Cipro which I have taken a number of times with no side effects. The second reaction was to a cortisone shot in my foot for arthritis pain which resulted in a swollen and painful foot. I am wondering if the “sartan” drugs are the problem. Do you have any knowledge of the “sartan” drugs causing reactions. I have had many cortisone injections through the years and no reactions. The two blood pressure meds are the only new drugs I have taken in the last year.

Is losartan from Canada also contaminated ?

I just got some with a batch# not in the list. However, all in the list expire in 2019-20. This bottle has a 2021 date. Does that make it safe, or did they just not get around to checking it yet? Has Legacy figured out how to make a safe batch and is this newer batch likely to be OK?

How do we get the FDA to do it’s job? Write your congressperson, senator and the President. They are supposed to be considering right now how to get compromise legislation to lower drug prices. If you read the current ARB story here, you will see an outrageous price difference between brand and generic. Price is related to ingredients, because Pharma’s big excuse for high prices is that they have significant research and development costs. Doubt that, and why would R&D make a difference if they can’t manage to get the ingredients that are harmful out of the drugs. I saw an article a couple of years ago that said that brand name ARBs have lesser adverse side effects than the generic ARBs. But now can’t find brand name Micardis (not recalled), so I can drop generic (Telimartasen).

I say we consult our doctor and arrange to purchase Diovan from Canada. Switch to plant based diet as much as possible, but it gets boring.

Is there a place on your website with a comprehensive list of the ARB’s that have been recalled? If not, would you consider posting one? For those of us who are trying to keep up with the recalls and cannot find any other medication that works, this would be helpful.

Thank you.

Until recently, I had high blood pressure, was on BP medication (including a recalled drug) and was overweight. Then I saw the documentary “Forks over Knives” and started eating a whole-foods plant-based diet. Now I’m off my medication, have normal BP and am a healthy weight.

I made the transition after finding a doctor on board with this plant-based plan and had my BP monitored daily. (If you continue taking your meds while reducing your BP through this diet, you could get light-headed and faint. A fall could injure or kill you, so monitoring your BP is a must.) For many people this way of eating also has also reversed type 2 diabetes and inflammatory diseases. The best way to avoid drug side effects is to eliminate the need for the drugs in the first place.

I am concerned about a dear friend on blood pressure meds who got a recall notice because, apparently, her pharmacy tracks lots, and the number appears on her bottle–or they say they do.

We have become our own doctors by default. We can’t always trust our doctors anymore, and maybe we never should have and just didn’t know it.

Now, with access to more information online, we can do our own research, and it often leads us in opposite directions than our doctors’ advice. The problem of course is that most of us are not doctors or scientists and cannot always decipher study results or know if they are slanted or funded by corporate interests. That’s the truly sad part of being a patient in this new world of too much information, too much misinformation, and few definitive answers.

At least those of us with enough time to track studies concerning our own or friends’ health/medial issues are aware of controversies. Those without the time or technical access don’t even know they may be at risk.

Unfortunately, sometimes ignorance is bliss, and partial knowledge incredibly depressing when it comes to health and our corporate medical complex.

I found out recently that many important drugs, including blood pressure medications and penicillin, are manufactured in China and other places rather than the United States. You may want to find out where the drugs you take are manufactured. This may be a risky situation.

Mine was finally recalled. So now I take 5 mg of my husband’s lisinopril and hope the cough I got two years ago on 10 mg doesn’t plague me. How many people are now becoming their own doctors? I might ask my doctor to replace my Losartan with Diovan and justify the prescription to my insurance company by saying everything else has the cancer content.

If food producers can list all of their ingredients on the label I have yet to understand why fillers and no essential ingredients cannot be listed on pill bottles. If the US can track where a specific head of lettuce was sold why can’t they also track where the API ingredient was sold. If the citizens of the US where told months or years later about contamination in a fruit of vegetable maybe then the outrage against the FDA and these drug companies would come to the forefront.All the money the drug companies receive and they can’t track where anything comes from is frightening.

I called my pharmacy about my losartan, and I was told the lot from which my drug came was not involved. I suspected they had no idea if that was true, that I was simply being told this to get me off the phone. And this is not my job anyway. This is the job of the FDA. Either they demand that drugs be safe, effective, and free of contaminants, or they don’t. How do we demand that they do their job?

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