The People's Perspective on Medicine

Physicians Finally Fed Up With the FDA and ARB Recalls!

The ARB recalls have generated surprisingly little outrage from physicians and pharmacists. But a perspective in the NEJM reveals that some docs are upset!

Week after week, month after month, we have been learning about ARB recalls. These angiotensin receptor blockers have been taken by at least two million Americans to control blood pressure or treat heart failure. According to our latest count (subject to change at any moment), over 750 different lots of valsartan, losartan and irbesartan have been recalled. Given that some of these lots involve bottles with 1000 tablets, this likely involves millions and millions of pills. At long last some physicians are speaking up!

Doctors Speak Our Minds!

We’ve been waiting for some time to see some outrage from mainstream medicine. We often feel like we are talking to ourselves when we complain about problems with pharmaceuticals made in foreign countries. Doctors and pharmacists have been strangely silent on this topic.

Now, though, there is an article in the New England Journal of Medicine (March 13, 2019) titled:

“Hypertension Hot Potato — Anatomy of the Angiotensin-Receptor Blocker Recalls”

These physicians point out that three “impurities” have been identified in ARB products. These nitrosamine impurities are not supposed to be in medicines that millions of people swallow daily. They have led to the ongoing ARB recalls. The authors state:

“These recalls are of growing concern to patients, clinicians, and organizations delivering primary care or complex, multidisciplinary health care, and they highlight several issues related to the readiness of our health systems to respond to drug recalls, trust between patients and providers, uncertain drug-dose equivalences, and the regulation of drug manufacturing in the global marketplace.”

They go on to note in the New England Journal of Medicine (NEJM):

“FDA officials believe that U.S. patients have been ingesting ARBs containing carcinogenic impurities for approximately 4 years…”

Really? “Approximately” four years! So, millions of Americans have been swallowing nitrosamines from their pills every day for at least four years and the FDA did not know about it. We find that unacceptable!

How Would You Know About ARB Recalls?

There is NO organized system in the U.S. to notify patients about recalled pharmaceuticals. The FDA doesn’t do it. The prescribing physician doesn’t do it. The manufacturer doesn’t do it. It’s left up to the pharmacy. But this is far more complicated and confusing than you would imagine. Many people learn about ARB recalls from the news media, newsletters like The People’s Pharmacy, social media or friends.

Once you hear that there has been a problem with certain lot numbers of valsartan or losartan you might think you could check to see if your pills are involved in the ARB recalls. You would likely be out of luck.

If your pharmacist took pills out of a big bottle and put them in a small amber bottle and stuck a label on it, you would have NO WAY of knowing the lot number. Pharmacists rarely, if ever, put lot numbers on the bottles they dispense. Only the original manufacture’s bottle has a lot number.

Let’s say your doctor prescribed valsartan to control your blood pressure or treat your heart failure. Your chain pharmacy may have purchased its valsartan from the Indian company Aurobindo. If you go to the FDA website you might discover that 80 mg valsartan tablets were recalled on March 1, 2019. Here are the lot numbers.

471170015A
471180004A
471180005A

If you were taking 160 mg of valsartan, the following lot numbers were recalled:


472180001A
472180002A
472180003A
472180004A
72180007A
472180008A
472180009A
472180010A
472180013A
472180014A

What Good Are Lot Numbers with ARB Recalls?

Sadly, this information may do you no good because your amber bottle won’t have lot numbers on the label. Even if you call your pharmacy and ask about your lot number, the pharmacy has no way of actually tracking what it dispensed in your bottle of pills.

In theory, the corporate office of your chain will guestimate that if your valsartan was dispensed in February, 2019 then it might have been in one of those bottles. You will likely get a letter that says something like this:

“This recall was issued because an unexpected impurity was found in these products that may cause health risks that may represent a potential health hazard or safety risk to patients who may be using product affected by this recall.

“Our records show you may have received a prescription for this product recently through your local XXX/pharmacy.”

Please note that the word “may” was used four times in those two sentences. They have no way of knowing the precise lot number you received if the pills were taken out of a big bottle and placed in one of their smaller amber bottles. Don’t believe us? Just check your amber pill bottles and let us know if you can find a lot number anywhere on the label.

Disappointed Docs:

The physicians writing in the New England Journal of Medicine go on to point out that:

“The burden of response has fallen to clinicians, pharmacies, and health care systems, most of which lack the infrastructure or resources to respond promptly to patients’ concerns.”

They also note that if a physician switches a patient from one kind of ARB, like valsartan or losartan to a different ARB like candesartan, olmesartan or telmisartan, there will be issues about dosing and side effects. The switch will require extra lab tests and/or visits to the doctor. As the number of ARB recalls mounts, patients keep being notified that they have to switch to another medicine yet again. The NEJM article points out that:

“the requisite additional switches have further undermined patients’ confidence in their clinician, their health care system, the drug supply chain, or all of the above.”

The ARB Recalls have led to Shortages:

So many lots of valsartan, irbesartan and losartan have been removed from the market that there are serious shortages. You can read more about this crisis at this link:

A New Carcinogen Found in BP Meds | More ARB Recalls!

To cope with this growing problem, the FDA has expedited the review of additional ARB products.

This week the agency announced that it had approved a new generic valsartan from Alkem Laboratories Ltd in India. The FDA reports that its evaluation of Alkem’s manufacturing process does not indicate a likelihood of contamination with nitrosamine carcinogens.

It may take weeks for the new valsartan to make it to your pharmacy. In the meantime, what are you doing about the ARB recalls? Share your experience in the comment section below. Have you lost faith in your pharmacy, the FDA or foreign manufacturers? We value your opinion.

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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 get all of my medicines from the VA and I was assured that there is nothing to worry about my Losartan blood pressure pills and I trust them unconditionally.

Just to let you know, I just went to my pharmacy to get new ARB ordered for me, Edarbi. Well, guess what, it has certain lot #’s just recalled also. A manufacturing process! I feel if one lot is recalled most likely they all should be recalled because they are all most likely contaminated!

If I did want to go ahead and get it (which I didn’t) it is not covered by insurance and would have cost about $250.

I’m thru trying ARB’s for high blood pressure and would appreciate any info on controlling by natural substances.

What a ridiculous situation. I agree with the suggestion that all prescriptions should be clearly marked with the actual manufacturer, country of origin, and lot number. Also that the FDA should mandate that if this situation occurs again – there be brand-name substitutions available at low/no cost to patients.

One last comment – I’ve been told by doctors and pharmacists that there is no difference in generics of the same drug (one manufacturer vs another). That is total BS. Anyone who has taken these types of drugs knows how their body responds (or doesn’t) to the proper formulation and dosage. There needs to be standardization of not only the active ingredient(s) – but also the inert ingredients as well. Only then can we be reasonably assured that we’re getting a comparable prescription when the pharmacies switch their purchase from one manufacturer to another…

FDA dragging their feet: Makes you wonder about all meds. Whoever heard of medications made in China and India. How did that nightmare ever happen? Plus their vitamins? Stopped because of side effects before recall.

Why does competition from generic versions NOT seem to lower the price of the name brand original?

I am on Telmisartan which comes in child proof blister packs and I usually get my prescription filled in the original manufacturer’s box. There are lot numbers and expiration dates on each blister pak and on the box. The company is Torrent and the box says the company is in India, yet this company has had many lots of other ARBs recalled…so this company in India must import from China???
I regularly get email notices on food,medical devices and drug recalls from the FDA. You can sign up for these emails on the FDA website.

I had an incident, and Teva wanted to know the lot number on my meds. It is not on our bottles. The pharmacy told me there was no way to know what the lot number is. This has to change. Lot numbers need to be on patients’ bottles that their meds come in.

I saw a photo of a massive pile of Warfarin sitting outside a building in India. It’s anyone’s guess as to what it could be contaminated with before it was packaged and sent all over the world. I have lots of problems with consistency, and our doctor told me many of his patients taking Warfarin do, too. I have to take a blood thinner, and ideally it should be under the same circumstances every day and I DO, but there are so many differences in my INR readings. I remember when it was Coumadin, and I didn’t have this problem then. But then Coumadin was made in the U.S.

I contacted my doctor regarding the first recall of Valsartan and he stated “there was no recall if there was we would have been notified and in turn notify you”. I replied “There was a recall and I was not notified”. I then stated I wanted another drug but not the Valsartan, so he switched me to Losartan. That was fine till I read on People’s Pharmacy of yet ANOTHER RECALL on Losartan.
I was livid and called his office, spoke with the manager and told her my story. Also call my pharmacy who confirmed I had the contaminated pills of Losartan and offered to switch me to another manufacture pills. Thanks to People’s Pharmacy I can keep up with all of these changes & have since DUMPED MY LYING DOCTOR, and now have a new very caring doctor who watches out for my health.

The FDA continues to prove itself not merely incompetent, but dangerous as well. The appear to be unable and/or unwilling to deal with RX, food, cosmetics and personal cares industries. It almost requires an act of Congress to get them to do anything. Sadly, I’m afraid nothing will change until several powerful politicians have close family members adversely impacted by FDA ‘s continued willful refusal to act. Shameful.

How can you lose something you never had?

yes

Yesterday I received a letter from Walgreen’s with “urgent product recall information” regarding my Losartan prescription. Due to my insurance plan, I have not had prescriptions filled at Walgreen’s for over two years! So what am I supposed to do now? Obviously I took my medication…can’t bring it back. I can keep the letter for future reference if I have any problems, though it states that the contaminated substance “occurs naturally in certain foods, drinking water, air pollution and industrial processes” so it sounds like a CYA against future lawsuits….just another example of a broken system.

I take Telmisartan (Micardis) for hypertension…haven’t yet seen it on the contaminated ARB list, but am going to research it’s origen.
Thank you for keeping us informed!
Nancy

I do not understand why all generic meds of this type are not required by the FDA to be switched to Brand name pharmaceuticals at the insurance companies expense until this is sorted out. If the brand name meds are manufactured in the USA then they should be safe for consumption. Insurance companies are complicit in this situation because they will not easily allow or cover the cost of Brand name medications.
I too have contacted my pharmacy and doctor to no avail – I seemed to have more information about the recalls than they did.

The bottom line seems to be, that the joke is really on the American consumer when it comes to the price of pharmaceuticals. The collusion between U.S. Congress, the FDA and Big Pharma insures that the are no price controls, and costs are influenced by the marketplace, meaning drug manufacturers can raise or lower prices of their brands as they see fit, while many foreign countries including Canada control the price of drugs. Adding insult, Americans are then told they shouldn’t buy from Canadian pharmacies because they can’t be sure of the quality of drugs which may come from nearly anywhere in the world. Wake up America, we’ve been had! What a disgrace! Corporate welfare needs to be eliminated.

Amazingly, I learned that my doctor wasn’t even aware of the problem (indicated via his nurse, plus that if I could identify what alternate Rx I wanted him to prescribe for me…to let him know!). His attitude didn’t seem to be at all concerned as well as indicating (incredibly) that doctors don’t generally get alerted or get involved with rx drugs being recalled, and that such issues are totally handled by the drug companies, the dispensing pharmacists, and by the FDA (can you believe?).

Oh well, since my Dr doesn’t seem to care, I’ll be continuing my own efforts to research for some decision-enabling quantification of the problem, as well as acting as my own doctor to determine what to do next, if anything. What a world we live in! And if I find out anything useful to this discussion, I’ll plan on returning to share it.

Joe Graedon – these meds are sent to the UK too. Alongside safety concerns re stents that people are already walking around with – it is not surprising that people refuse medical intervention. This is what happens when money is the driving force and not the moral (and safety) imperative.

I was on losartan for any years and was changed to candesartan a few months ago. Shortly thereafter I was diagnosed with bladder cancer, one cancer I was not at risk of getting unlike two others. I will no longer take anything from China to put in my mouth or my pets. To top it off Trump just cut a bunch of funds to the FDA. Doesn’t help much, does it?

Now that we know about the recalls, what IS a safe blood pressure medicine?

I think pharmacies purchasing these drugs should be testing them for safety before selling them to us. Maybe they need to be reminded that they are probably legally responsible for the safety of the product they sell. Obviously the govt isn’t feeling responsible.

So glad I went on blood type diet and my B/P dropped to normal range & I lost 10 pounds, dropping to the dress size I wore 50 years ago. Never thought that eating the wrong foods could make one as ill as I have been over many decades, having illnesses from severe indigestion to a near-death bleeding ulcer and gall bladder removal. After taking a number of the suspect B/P drugs over the years–none of which worked well and most of which made me feel bad, I’m so lucky that eating the right foods saved me from the fear of an Rx drug induced illness/death . With a good vitamin/mineral regimen and careful attention to what foods I eat, I’m better than I ever have been. I can only wish such a good result for others…but many won’t even consider giving up the foods that hurt them and that create the need for medications. Popping a pill is easier than changing eating habits, I guess. A pity, that.

I just talked to my good Vons pharmacist. Re:Losartan 100 mg, manufacturer is Auro. She said they check the lot numbers on Big bottles to make sure they are not in recall. She said my pills were okay to take. Lot numbers were not in recall. So I will continue taking and checking in with Peoples Pharmacy. At this point I feel I have to trust someone and I do. My pharmacist.

The drug companies should be responsible for the purity of the drugs that they sell. They should send THEIR people to inspect the drug companies that produce their medications. If they can’t prove their meds are not contaminated they shouldn’t be allowed to sell them by the FDA.

As I understand it, the drug companies cannot be sued, thanks to laws passed in Washington.
We need to know who voted on this law and publish their names, so maybe they will be voted out of office

Thanks for the alert on Losartan….I had been taking the 50mg dose and my doctor recently increased it to the 100mg dose…so I was taking 2 until the Rx. would run out, which happened within that same week… but when this alert came I checked with my Walmart pharmacy and there the pharmacist DID KNOW the lot number and company….indeed it was immediately known my rx. was on the affected list…. My pharmacist was most concerned and had already ordered another company’s safe brand coming in a couple days….she gave me a safe brand in my increased dosage for a couple days until the new order arrived…and this was before I had received the letter a week later from my local pharmacy about the recall. So thank you Peoples Pharmacy for writing about this recall as I checked at once with my local Pharmacy to correct this problem…..

Last I knew, the FDA is funded by the Federal govt which is a watchdog for its citizens.

We pay taxes to the federal govt. therefore they work for us.

Strong case for derelict of duty. Isn’t that punishable by law?

I am appalled that pharmaceuticals are not traced by batch and lot after they leave the pharmacy. It should be required to be put on every prescription label that is ever printed. My husband and I both take Losartan and received a letter about the recall. After checking our bottles and calling the pharmacy I found out first hand that you can’t trace them. And of course a pharmacy is not going to buy such a popular medication in smaller quanties so asking for them in the original container is not going to work either. And going without is not an option. What a screwed up mess!

We are in a damned if you do and damned if you don’t situation. I have done everything in my power to find out if the valsartan I take is from a good lot. I check the “FDA Not Recalled lists”,
I have the pharmacist pull out the big bottle on the pharmacy shelf to verify the lot number, I even called customer service at the pharmaceutical company and spoke to them. They swore up and down that the lot was ok. And guess what? Just received a letter from CVS saying that my valsartan might be tainted and to return the pills. I had already taken a majority of the pills. I mean, so what’s going to happen? A lot of older people like myself, try to stay healthy. We eat organically, exercise, take supplements and for what? The pharmaceutical customer service rep went on to tell me (in a round about way) that this was due to a wholesaler selling these tainted materials. So who knows who has the right info? Sounds like passing the buck, but to our expense.

well, another reason people are prescribed meds to reduce BP is that the docs themselves changed the definition of hypertension!! Made more of us being told we are hypertensive and need a pill! More Interesting that efforts are underway to let American consumes purchase medicines from Canadian pharmacies!! Fraud and racketeering IMO.

I have sent my doctor two messages, one written, one a phone message, that I received a letter from my pharmacy about my Losarten. The Lot numbers are on the recall list. Two weeks and no response. What do I do now? So frustrating!!
Rebecca, Mebane, NC

Are these recalled meds made in places like India and China? Is it noted on labels (like on clothing) where they’re manufactured? Why not….??? Could that be part of the problem..???

This news is a disgrace; my faith is no longer rock solid.

I stopped my losartan for 3 days but my pressure soared and I got scared. So I have to take a chance and I do;

Seems at lest a partial solution would be to require lot numbers linked to prescription numbers. Better yet, require manufacturer and lot number on all prescription labels. It then empowers purchasers to check if their item is recalled and provides an easy means for recall notifications. We do this with our food after all.

Thank you for all that you report on. We will only purchase brand name drugs for our blood pressure medications. My husband has had two strokes and we are not using meds made in China. I wouldn’t give my cat…….. food made in China. We pay dearly for brand name drugs and are thankful we are able to pay for them.

Paula

The FDA has recently approved a generic of valsartan from Alkem Laboratories Ltd. (India) after determining that the manufacturing process did not contain the nitrosoamine impurities. I do not know when/if their product will be available in the US.

I am very concerned. I can’t find out answers. On the first recall I was put on losartin which also seems to be affected. My pressure was really screwed up by this change. I’m back on valsartin but I have no confidence that it is good to take. Diovan the brand is so expensive that I can not afford to take it. Do I die from cancer or heart attack or stroke?

And they wonder why we go online, research and try to treat ourselves with natural things.

Perhaps a tiny bright spot in this horror is that hopefully many more patients will start asking questions, educating themselves, and advocating on their own behalf, instead of meekly following any and all recommendations under the false assumption that their best interest is always at heart and the medical machine is running smoothly and flawlessly. Maybe there should be a “less is more” approach in the world of ‘no such thing as too many drugs” health care.

When a recall as large as this one and as ongoing as the ARB recall is I think the government should step in and allow the Brand to be substituted at no additional cost to the patient. As an affected patient it is so frustrating to be bounced around when there is an alternative. Maybe the PBM should have to eat the cost difference. Or maybe the brand should be distributed to affected patients through their physician for free.

I have not heard anything from my pharmacy or doctor concerning this serious recall problem. Wa going to contact my pharmacy until you reported that they have no way of knowing what batch they have given you. I take 100 mg. If Losartan daily. Scary! Thank you for alerting us.

Very disappointed in this day and age that something as simple as having lot codes on pill bottles is not required.
Also manufacturers have placed consumers at risk by moving manufacturing to China and India. Disgraceful.

Thank you for reporting the Recall on Valsartan…..This has been going on too long … It is a disgrace that people have been exposed to carcinogens while trying to control their blood pressure / heart issues . Thank you for diligence in continuing alerts .

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