angry doctor

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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  1. Dale
    slidell,la.
    Reply

    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.

  2. Mary
    Little Elm, TX
    Reply

    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.

  3. Joe
    Illinois
    Reply

    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…

  4. clara
    Reply

    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.

  5. Richard
    Florida
    Reply

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

  6. Karen
    98802
    Reply

    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.

  7. Debra S.
    The Americas
    Reply

    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.

  8. Ann H.
    Canada
    Reply

    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.

  9. Demetrio Montoya
    CA
    Reply

    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.

  10. Debra
    Reply

    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.

  11. Sally
    WA
    Reply

    How can you lose something you never had?

  12. Walt Lupo
    South Carolina
    Reply

    yes

  13. Marla
    Dallas, TX
    Reply

    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.

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