safety concerns

The Food and Drug Administration has expanded its recall of the blood pressure drug valsartan for the third time. On July 5th the European Medicines Agency issued an alert that Chinese-made valsartan contained a probable carcinogen called NDMA. At that time 22 European countries were impacted by the valsartan recall. Over the last month, the valsartan recall disaster has spread around the world.

FDA Warns, Then Updates and Updates Again:

A week later on July 13th the FDA announced a recall of several drug products containing the contaminated valsartan. The FDA updated its recall notification on July 17th and again on July 27th and again on August 2nd and again on August 9th that additional companies were involved.

The latest addition to the list was just announced by the FDA on Thursday, August 9th:

“Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals.

“Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang…

“Recalled valsartan products labeled as Camber may be repackaged by other companies. FDA will provide updates as more information becomes available.”

Valsartan Drug Shortages!

Do you get the sense that this evolving valsartan recall disaster keeps evolving? Now we see that the FDA has added valsartan to its Drug Shortages list on August 3, 2018!

We’re not surprised. The generic industry has consolidated. That means there are fewer manufacturers making raw ingredients and finished products. A great many of them are located abroad.

If a large company in China or India develops a problem, that can affect the supply of your medicines at a local Walgreens or CVS. We suspect that quite a few pharmacists are calling around looking for safe valsartan.

What Companies Are Involved in the Valsartan Recall Disaster?

According to the FDA, here are some of the companies affected:

  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC.
  • Teva Pharmaceuticals USA labeled as Actavis
  • AvKARE
  • Remedy Repack
  • A-S Medication Solutions LLC
  • Bryant Ranch Prepack Inc.
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • NuCare Pharmaceuticals Inc.
  • Northwind Pharmaceuticals
  • H J Harkins Company
  • Proficient Rx LP
  • Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.

Here is a list of the actual products affected. The FDA updated this list on August 8, 2018.

We wrote about the worrisome implications of the valsartan recall disaster at this link. We fear that the FDA’s ability to monitor generic drug manufacturing in countries like China and India leaves a lot to be desired.

The FDA itself admits that:

“The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years.”

That’s right…”as long as four years.”

How Are Americans affected by the valsartan recall disaster?

Hundreds of thousands of patients are likely impacted by this recall mess. Pharmacists will be trying to find people uncontaminated valsartan. Others will likely be switched to drugs in the same class. They include:

Irbesartan

Losartan

Olmesartan

Telmisartan

Take Home Questions:

We find this whole valsartan recall disaster worrisome for several reasons. How did this problem persist for four years without the FDA detecting it? Are there other ticking time bombs out there that the FDA hasn’t even considered?

Will people exposed to NDMA in contaminated valsartan be at greater risk of developing cancer? Will anyone bother to find out? We suspect that neither the FDA nor the Chinese drug company that is responsible for the contaminated valsartan will ever do the research necessary to answer that question. It could take decades and cost tens of millions of dollars.

How can Americans trust the Food and Drug Administration to protect them from foreign-made pharmaceuticals? The FDA’s inspection process is very different in other countries. For one thing, the agency has to notify the governments and the companies well in advance of inspections. In the U.S., FDA inspections are unannounced.

Learn more about these and other concerns by listening to our recent podcast. You can listen to the streaming audio or download the mp3 file for free at this link.

Show 1131: Was Your Medicine Made in China?

Share your own thoughts about the valsartan recall disaster in the comment section below.

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  1. Lucy
    Brooklyn, ny
    Reply

    I read the book China RX. Everyone who takes any meds should read this book. You can borrow it at your local library. It tells us how our big drug companies sold out to China and the unsanitary conditions in which drugs are manufactured, where workers relieve themselves in a bucket. Where there is little access for inspections. You will have nightmares. I am so scared for my husband who takes Sotalol, a heart med that has so many serious sides effects and is made by Tera lab. A few years ago they were recalled, but it was the120 mg dose he is on 80 mgs I can,t afford the brand name, and who knows if that is safe. I also, when reordering. The pharmacist says it is on back order. What can we as consumers do?

  2. chris
    san francisco
    Reply

    With generics in general it is buyer beware–we just do not know what is in them and again we see the failure of the FDA to properly police them and protect the public. Generally, manufacturers of generics cannot be sued for illnesses that result from them that the brands did not warn of (https://www.bowmanandbrooke.com/insights/supreme-court-rules-makers-of-generic-drugs-cannot-be-sued-for-failure-to-warn-06-23-2011). However for those of us seeking to avoid them altogether, the are limited. In California and Massachusetts the discount coupons that companies offer for brand name drugs will, for the most part, not be honored (https://www.lexology.com/library/detail.aspx?g=5bad7782-3316-4a19-8b56-c94b5d0ede99). Other states may follow suit. What is a consumer to do when the FDA does not protect us from poison and insurance companies care only about profits themselves?

  3. Hermine
    Columbus, OH
    Reply

    I took a 300 mg tablet of Irbesartan one time for high blood pressure and it almost killed me. Dizzy, lost my balance and breathing problems followed. I had a EPI-Pen available for my allergic reaction towards bee stings. I immediately used it and breathing returned to normal. I will use Dyazide 37.5/25mg Non-Generic to control my high blood pressure. Before was eating too much salt (Sodium Chloride) and now have eliminated from my diet

  4. Bobbi
    Texas
    Reply

    I’m concerned about what type of cancer this could cause. Should we do regular testing in certain parts of the body? My pharmasist just brushed my questions about this aside saying lots of products have carcinogens in them. My point is, if I know that I don’t use the product, and I have used Valsartin for years.

    • Mitch
      Boca Raton
      Reply

      Bobbi – you need to find another pharmacy. The only way this will change is if consumers refuse to buy generic drugs made in China. There simply are not the same protections in China as in other countries. Plus, China has a long history of selling bad products to the U.S. (Chinese drywall, lead-based paint, tainted pet food). I can’t ask you enough to write your congress person about this. Write your senator about this. In my case I was buying the tainted valsartan for years. I had no idea it was coming from China. Now I refuse to accept any medication if the pharmacist cannot show me where it was made, or if it came from China. The fact that this went on for “as long as four years,” as the FDA says, indicates that the oversight of this company was woefully inadequate. It really is buyer beware. You have to look out for yourself.

      • Helen
        Kansas
        Reply

        I had no choice from my employer but to get medications by mail order pharmacy (Optium RX) OR I would have no coverage and would have to pay full price for all medications. Of course the employer (yup an insurance company!!) wanted to get the cheapest possible so I ended up with the contaminated Valsartan at least back to March 2013 confirmed so far. I have absolutely NO family history of ANY cancer as we all die from some cardiovascular related event/disease, hence the reason I was taking Valsartan for elevated BP. Sure enough I came down with not one but TWO independent/separate cancers that were diagnosed while working up another medical issue. How does one person come down with two separate cancers in a NO cancer family history? Just take the cheap, contaminated Valsartan from China!! Problem is the rats studied only found liver and kidney cancer yet mine was Uterine and Ovarian. Remember these were accidently found while being worked up for another benign medical issue. Who knows how long it would have taken for me to show signs of these cancers.

  5. Nancy
    New York
    Reply

    My husband has been on this for YEARS. He is in Memorial Sloan Kettering with a brain tumor.

    This is a slow response to Valsartan. We trust that our drugs will be safe. So did VALSARTAN cause my husband’s cancer. His drugs cam tainted.

  6. Verbgram
    AR
    Reply

    Follow the money. FDA is a legal killer with government’s blessing. To believe they have a person’s health interests v. Big Bucks is sheer nonsense. It’s disgusting and shameful.

    • Doug
      Lincoln, Ca
      Reply

      I agree, the FDA is slowly killing us and we are being brainwashed by the commercials
      that try to make everyone think they need a certain drug because they MIGHT
      develop a certain condition. and the doctors are all behind this-doctors are not happy
      unless they prescribe a drug- all of this is total insanity

      • Dot
        Seattle
        Reply

        Absolutely right Doug. I need to add that you won’t hear about it on any main stream media news because of the big bucks given to them to run RX ads. What a racket.

  7. Larry
    North Carolina
    Reply

    Who is checking to make sure that Irbesartan, Losartan, Olmesartan, and Telmisartan don’t use raw ingredients from the same source Valsartan manufacturers use?

    • Gloria
      Maryland
      Reply

      My thoughts exactly, Larry. I was diagnosed with cancer last year. I have been on irbesartan for years. Hetero Labs makes my medication for Camber.

    • Mitch
      Boca Raton
      Reply

      Larry – I did. I got losartan. I verified the NDC number on the internet and was able to view the label from the manufacturer on the internet and the bottle (only if you get 90 day supply) that showed it was made in India, and not by any of the companies that produced the tainted valsartan. Unless the consumers educate themselves and ask the pharmacy about the origin, the pharmacy will keep buying the cheap tainted junk and selling it to us.

  8. Victor Butschek, R.Ph.
    TEXAS
    Reply

    The valsartan recall is remarkable to me in that no actual harm from either the contaminant or Valsartan has been documented. At least per the Apha/fda emails I have been getting. It seems to all be theoretical. How that has developed into a major recall is a subject in itself.

    As to the “problem” about foreign manufacturers, that has been going on for decades and is how most of the drugs we use daily are done. It is very expensive to set up to manufacture a specific ingredient so it is much more efficient to just buy that component. That is a common practice in many industries, not just drugs. And the chemists in India or China or Germany or Switzerland are at least equal to those in the US in education and ability. And regulatory oversights occur in every country including the US.

    At our pharmacy we receive recalls for various reasons pretty much every week. My opinion is the USA pharmaceutical manufacturers are behind much of the doubt created by labeling a chemical made elsewhere to support the mark ups here in the US. As an example a broadly used inhalant is manufactured in India and retails there for about $5. The same product with a US label wholesales here for over $300. And yet there is discussion and cautioning about “foreign made drugs” being somehow questionable. With pharmaceuticals it is sometimes difficult to separate good science and marketing. Seems to me that marketing sometimes trumps science.

  9. Jane
    CO
    Reply

    I wonder if drugs and their ingredients will be subject to the strong new tariffs imposed on China??? I’m betting not… too much lost revenue for those in power. If taxes and tariffs got too high, big pharma might not be incentivized to keep outsourcing and higher costs could mean lower profits right? Nah… you could just keep raising the prices

  10. Bob
    Georgia
    Reply

    I’ve been on Valsartan for years, never had any problems. When I reported the recall to my doctor, he immediately changed me to Losartan. No problem with this either.

    • Helen
      Kansas
      Reply

      Bob congrats if you don’t “have” or later “get” cancer BUT you didn’t given enough details. Did your Valsartan from from the China? Did you have scans, CA125 or ANY tests to show you don’t have cancer and just haven’t yet had symptoms? I had been on Valsartan (from China) for years and had NO PROBLEMS AND NO SYMPTOMS OF CANCER. Then while investigating another medical issue was diagnosed with TWO separate/independent Primary cancers at the same time. I come from a NO cancer of any type family history we all have cardiovascular issues hence my need for Valsartan in the first place. Again hope you were one of the lucky ones, I was not.

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