safety concerns

We are getting very tired of saying “Not Again!” Sadly, though, this has become a surprisingly familiar refrain here at The People’s Pharmacy. This time it is another ARB (angiotensin receptor blocker). Some irbesartan is contaminated. We don’t know how many pills are affected. It almost doesn’t matter. We are fed up with foreign-made drugs showing up with carcinogen contamination. What about you?

First Valsartan Now Irbesartan is Contaminated:

It all started around July 5, 2018. We discovered that the European Medicines Agency (EMA) announced that a Chinese-made version of the blood pressure drug valsartan (Diovan) was contaminated with N-nitrosodimethylamine or NDMA. This probable carcinogen was found in a number of valsartan products. Read our special health alert here.

On July 13, 2018 the FDA took action too. Since then there have been frequent announcements of additional valsartan products that were contaminated. Find the list of affected products here.

The total number of contaminated pills is mind blowing. Here is a link to many of the manufacturers that got into trouble with their valsartan. Now we have learned that a related drug, Irbesartan is contaminated too.

Irbesartan is Contaminated: How Ironical

Like valsartan, irbesartan (Avapro) is an ARB (angiotensin receptor blocker). Many people taking valsartan to control their blood pressure were switched to irbesartan when the FDA announced that valsartan from several different companies had been contaminated with a carcinogen.

The New FDA Announcement that Irbesartan is Contaminated:

“ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API [active pharmaceutical ingredient] Irbesartan, USP manufactured by Aurobindo Pharma Limited.”

Companies that sold irbesartan include Westminster Pharmaceuticals and Golden State Medical Supply, Inc. Consumers are urged to examine their tablets and consult their pharmacists to determine if their irbesartan is among the lots being recalled.

Are you Getting Tired of Drug Recalls?

It’s bad enough when a car company issues a recall because of a problem with ignition switches or air bags. We are even more alarmed when we are told that millions of people may have been exposed to a carcinogen in their medicines. Swallowing a potentially cancer-causing chemical for years is unforgivable.

It will be virtually impossible to tell whether exposure to one of the recalled drugs is responsible for cancer. Many patients will wonder as this reader did.

Nancy in Georgia would like to know if this is a coincidence:

“I have been on (the recalled) valsartan for several years. I had to call my pharmacy about the recall. I knew before they did. They had to check. They exchanged my pills for ones made in the US. And, now I have pre-cancerous cells in my breast and will be having a lumpectomy. Coincidence?”

What About Other Recalls?

Shari in North Carolina reports a concern about hydrochlorothiazide:

“I took my husband’s prescription for hydrochlorothiazide in to the Walgreen’s where I purchased it. The pharmacist said his was in the recalled batch according to this information put out by the FDA. She gave me the number to call for Accord.

“When I called, the person I talked with said ours was not the pill that was recalled-so the FDA information was incorrect. She said the recalled pill is yellow and has an AB on it. This is very confusing and does not make us trust the information that is coming from the FDA-nor from the pharmacist!”

Mary is also confused:

“I too called that number, and the lady was adamant that my lot was safe and that the recall was the yellow one, which does not fit the description of the recall. This sounds dangerous enough to confer with a physician for an alternative or nothing.”

People’s Pharmacy Perspective:

Making medicines is not like making widgets. If a potato peeler or a tennis ball is imperfect it is not life threatening. If a medicine is contaminated or contains the wrong dose, it can be life threatening.

Perhaps it is time for the FDA to tighten its monitoring process. If a drug company makes a mistake, we think the executives should be held accountable.

What do you think about all these recalls? Share your thoughts in the comment section below.

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  1. Daniel J.
    Hartford, CT
    Reply

    I too read the book ‘China RX’. Required reading for all Americans. China has often blocked U.S. pharma reps and U.S. inspectors from getting into many of the plants in China that make these drugs, per the book. How did this happen? Well, politicians for the past 20 years have been getting elected by telling the public that drug prices are too high. In response to this pressure, the drug companies moved almost all production offshore, mostly to China. The quality has suffered. China now has the upper hand and can literally shut off our drug supply if we don’t submit to their demands, i.e., back off on on-site inspections. Big Pharma has no choice but to back down, as they no longer have fall-back USA production facilities.

  2. Mary
    Little Elm, TXE
    Reply

    I wrote on November 9th that I felt that the best way to fight this problem is to contact our Congressmen. Since I was a nurse for over 30 years, I feel that contacting Congressmen who are physicians might be a good way to start. There are 15 of them. If you google, Congressmen who are Physicians in the 115th Congress, you will get a list of them and the state they are from.

    If we could get some of them interested in passing a law that holds the drug companies financally responsible for impurities found in their products it would a game-changer. The FDA could be held accountable for assuring that the drug companies’ results are accurate. I don’t believe it is possible to stop getting the drug ingredients from China, India or other countries. It saves the drug companies a lot of money.
    I suspect that the reason the drug companies are not held accountable now is because they got someone in Congress to pass a law not holding them accountable. I hope some of you will follow up on this. It is just too important to ignore.

  3. Emily
    New Mexico. USA
    Reply

    And the FDA !! Listed that Reumofan Plus !! Mfg in MEXICO was dangerous!! This pill does wonders for ostoarthritis pain!! There are three ingredients in the pill ( which I have a separate RX for all ) from my GP !! I do not take those three pills pills together !! I take Reumofan Plus ! One pill about twice a week ! To help control OA pain !! Reumofan also has other natural ingredients!! Lots of info on the WWW !! About the product !!

  4. Gail
    Virginia
    Reply

    I got a prescription from a new pharmacy for a drug unrelated to the recalled drugs, but when I discovered that it was made by the same Chinese manufacturer, I went back to the store and told them that I would not take anything made in China and to pass that information on whoever orders the drugs. Then I got it filled at my old pharmacy even though it costs more. I could have been risking my health for $14 a month!

  5. Sea
    New Hampshire
    Reply

    If you think “ironical” is a word, I worry about the accuracy of ALL of your info!

  6. Regina
    Georgia
    Reply

    So many of our drugs are being made overseas in India and other countries! How can we keep letting this happen? We need to make all of them here so they will be regulated!

  7. Dot
    North Carolina
    Reply

    I, too, like Nancy from Georgia (above) had been taking valsartan for several years. When I received notice in the People’s Pharmacy newsletter that this medicine was being recalled, I went to my druggist at Walgreen’s and they had just received their notice; was given a phone number of their US supplier of this drug. I called them & got no satisfactory response other than their taking my phone number, name, etc. I was told I would be contacted later which has not been done as of 11/9/18. My doctor then prescribed another medication for me (losartan). Then when I went for my annual mammogram in August, I was diagnosed again (after being clear for 32 years & lumpectomy & a quadral mastectomy in1986 for a previous diagnosis of DCIS) with a malignant carcinoma in situ & had another lumpectomy & node mapping on October 16th. Path reports were good news–nodes negative and CIS removed. Now having to be very vigilant about medications and discussions with doctors during checkups!! We also as consumers need to hold the FDA and drug companies accountable to make sure the medications we used are safe.

  8. Mary
    Little Elm, TX
    Reply

    It’s time to take some action regarding all the contaminated drugs we have probably been getting for a long time, both from foreign countries and ones made in the US, if any. I suspect that the ingredients are from other countries and then the drug companies here put them into pill, capsule or IM or IV form. We need to bombard our congressman with protests. The FDA and drug companies seem to have too cozy of a relationship. It seems most of the European countries were told of the Valsartan problem long before the FDA acknowledged it in the US.
    I believe the drug companies should be held accountable (financially) for their drug impurities first of all, then the FDA needs to check the results of their findings to make sure they are as pure as possible. If we could get a list of the many congressmen who are doctors, we can start by bombarding them with our concerns. They or their loved ones will likely be using meds at some point and would be concerned about them. I am also wondering if the cargo ships that they are sending the drug ingredients over to the drug companies on may be part of the problem. Could The Peoples Pharmacy draft a letter that we could use as a guideline to send to our congressmen?

  9. B
    USA
    Reply

    Today I get a recall notice for Losartan HCTZ, it’s never ending seems like

  10. Sandy
    Reply

    Why don’t we stop getting our medications from China and make them here in the USA, get them from Europe or Canada. If a tariff on China is needed on other goods, one on Chinese medications is needed or even a total restriction.

  11. john kassen
    WA
    Reply

    Drug company’s can’t be trusted on their own.All they care about is their bottom line,enough please. FDA do your job,now.

  12. Sylvia
    CA
    Reply

    Since having a terrible experience with Levaquin I am frightened of all medications and try to be extra careful, but I am constantly blind sided by doctors and pharmacists ignorant of new developments and recalls. In a sane world Pharma TV commercials would be banned and MDs would not be allowed to receive any emoluments.

  13. carolyn
    st petersburg,florida
    Reply

    I think it is horrible.I thank IRBESARTAN.What do i do now.The pharmacy says it is fine. How do i know.?China is so bad.People in the u.s. better wake up.

  14. Delores Danzine
    FL
    Reply

    What about Losartan

  15. skillinge
    WA
    Reply

    What about Losartan, which I have just started taking? It does not really reduce blood pressure anyway.

  16. jane
    CO
    Reply

    I’m wondering why the FDA allowed the outsourcing of drugs and ingredients in the first place. They have little enough oversight right here in this country and virtually none in other countries. Could it be pressure from big pharma? Could it be financial reward from big pharma(i.e bribery)? Could it be pressure from the “hill” where many are no doubt reaping huge financial rewards from their investments in big pharma? Hmmmm….. I DO wonder.

  17. Laurie
    Chicago
    Reply

    I wonder if Losartin will be next. Does anyone know if this is in the same class as these these other two?

  18. phyll consentino
    MA
    Reply

    which irbersartan pills have been reported unsafe

  19. Frank S.
    Florida
    Reply

    The bottom line is we need to get a handle on drug pricing and manufacture all of our pharmaceuticals right here in the U.S. Whatever else we import is of secondary importance.

    • Mary Reynolds
      TX
      Reply

      I just watched a show about all these generic drugs being made in China. A woman wrote a book about it called China Rx. It really scares me, since I have chronic health problems and am on a lot of meds.

      How can I find out where they are made? Are the brand names made in the USA?

      Yikes!

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