safety concerns

On July 15, 2018 we issued a People’s Pharmacy Health Alert: Valsartan Blood Pressure Pills Recalled Over Cancer Concerns. We tried to provide you, our faithful readers, the story behind the headlines. In a nutshell, the FDA followed the lead of drug regulators in Europe, Canada, Japan, Hong Kong and Taiwan by encouraging the recall of certain generic forms of valsartan. This heart and high blood pressure medicine was contaminated during manufacture with a carcinogen called NDMA. The affected valsartan came from a Chinese manufacturer. Companies that have been affected by the voluntary valsartan recall in the U.S. include Teva’s Actavis, Major Pharmaceuticals and Solco.

The Valsartan Recall Gets Murkier:

The Valsartan recall has opened Pandora’s box. There are questions about Chinese manufacturing of generic drugs. Then there is the whole issue of FDA oversight of foreign generic drug manufacturing. What are the implications for U.S. patients?

When Was the Valsartan Problem First Discovered?

If you read the news stories about the valsartan recall you might get the impression that this is a brand-new problem. Here is the official FDA New Release updated on July 17, 2018:

“The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

We highlighted the last sentence. One might assume that this “unexpected” problem recently occurred because of “changes in the way the active substance [valsartan] was manufactured.”

The FDA commissioner goes on to say:

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”

When Did the Valsartan Problem Start?

It is not clear when valsartan was first contaminated with the carcinogen NDMA. Here is what we found in a July 17, 2018 Reuters health news release by Ben Hirschler:

“A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday.

The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk.

The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied valsartan on July 5, said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.”

How Many People Were Exposed and for How Long?

If the Reuters article is correct and the problem with the Chinese manufacturing of valsartan dates back to 2012, this is an even bigger scandal than we first imagined. As we reported in our July 15 Special Health Alert, millions of people take valsartan daily to control high blood pressure and treat heart problems.

Here are some other questions we would like the FDA to answer:

  • When did Zhejiang Huahai change its manufacturing process?
  • Was the change approved by the FDA?
  • Did the FDA review and test the “new” valsartan made by Huahai?
  • What kinds of testing does the FDA require for detecting potential carcinogens in the manufacturing process?
  • How does the FDA verify that pharmacies are recalling tainted products?
  • Will patients have to pay for new valsartan or will the manufacturers of recalled valsartan provide refunds and quality substitutes?
  • How will the FDA prevent a shortage of valsartan now that a major manufacturer has recalled so many pills?
  • Can the FDA guarantee that other Chinese manufacturers of generic drugs are producing quality products?

Readers have responded to our Valsartan Recall Alert:

We have heard from many people about the valsartan recall. Here are just some of the comments we have received:

Abigail in Texas says:

“Either the FDA or big pharma needs to provide an opportunity to test our leftover valsartan pills for trace amounts of NDMA to ease all of our minds.”

Ellen in California wants to know why country of origin is not on the drug label:

“I do not understand why something we swallow does not have to be labeled as to country of origin when something we wear (clothing) does.”

Dorothy in Lake Havasu City, Arizona, is worried:

“Thank you for putting this information out as soon as you heard about it. I have been taking generic valsartan for years. My present prescription says: MFG. Solco, one of the recalled ones. I am one of those people who do not like taking prescriptions, but have to take BP meds. Needless to say, this frightens me.”

David H in Monroe, Louisiana, poses a key question:

“RE: Valsartan recall:

“Getting conflicting info from local pharmacies. Due to different insurance, my wife and I use different pharmacies. Both of us have valsartan by Solco. Her pharmacy says the recall is by lot number and she is ok. My pharmacy says recall is by manufacturer regardless of lot and is sending me a replacement. Any info as to who is right?”

To answer David’s question: His pharmacy is correct. The recall is by manufacturer. As far as we can tell, all lots of Solco valsartan have been recalled. His wife’s pharmacist was blowing smoke.

You can learn more about the valsartan recall at this link.

We have been writing about foreign-made generic drugs for quite some time. Our book, Top Screwups reveals serious flaws in the generic drug approval process.

You may also want to check out a book titled ChinaRx: Exposing the Risks of America’s Dependencer on China for Medicine by Rosemary Gibson and Janardan Prasad Singh. Here is a link.

Share your thoughts on the valsartan recall in the comment section below. Do you agree with us that this could be a bigger scandal than we originally imagined?

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  1. Jodi
    Illinois
    Reply

    I remember when our pets died from food made in China. I do my best to not purchase things from China, especially dishes because of the lead issue we had with them in our toys in the past. I recall a woman who was investigated by an American journalist who went undercover and acted like a buyer to uncover what this woman was doing with medications. She was putting cement powder in the medication and people here were suffering because it was used in heart medication. This woman was secretly videotaped and she was not remorseful at all. She laughed it off because she was making a lot of money. I don’t understand why our country is even allowing medication from China in our country. My husband has been taking this medication for a long time. I love my husband and I do not want anything bad to happen to him so I am praying for God to counteract any damage this may have caused him.

  2. Carole
    Riverhead, NY
    Reply

    The reason there are laws is to keep people civilized and prevent them from needing to take thimgs into their own hands. So. If the law cannot help us, we must take things into our own hands. I think we should all (everywhereJ boycott ALL products not produced in our own country, with proper oversite by our own regulators. I would say “medicines and foods”,but I think we need to SMASH the complacency that has allowed this mess.

    And, if our own regulators cannot protect our best interests, we need to FIRE THE WHOLE PILE OF THEM, regardless of political party. GONE! And get new people in. They will certainly make mistakes, too, but not as willfully as the present people.

  3. MISSY
    USA
    Reply

    What is being done about this? Anyone who’s been taking this since 2012 should be paid damages because they lied to us and risked our health. What needs to be done to start a class action suit?

    • Donna
      Smyrna, DE
      Reply

      Yes I have been taking Valsartan for 4 years and I am very concerned as I am sure everyone is. Walgreens have me a phone number to call Solco but it was a useless number. I called Walgreens back and told them the number was no good and then was told ” well we cannot take it back. That is the number they have us to pass to customers “.
      My biggest concern, other than the obvious, what was the FDA doing? Why are vendors of medicine companies not required to put the place of origin on the medicine bottle?

    • Irene Y.
      Reply

      I agree this is terrible. They need tighter regulations or make our medicine in USA.

  4. Mitch
    Boca Raton
    Reply

    I have taken generic Valsartan for 4 years, most of it from SOLCO. I’m outraged. SOLCO is based in New Jersey, but (per their own website) owned by the Chinese generic manufacturer, Zhejiang Huahai – the one that made the bad API in the valsartan. This article has some of the very questions I sent to the CEO of Walgreens today.

    I’m baffled at how, with all the tainted products coming out of China, our pharmacies will still purchase drugs from China. The fact that the valsartan problem existed for years, and no one knew it, indicates to me that there is a serious problem, and it is my hope that Walgreens and other pharmacies will STOP SELLING THIS GARBAGE. Consumers MUST START ASKING WHERE THE MEDS CAME FROM.

    I will never ever take another generic without investigating the manufacturer, prior recalls, country of origin, etc. How is it that this could have gone on for so long without being detected? Who was testing this medication? Will Zhejiang Huahai be allowed to continue to supply meds in the US? Frankly, I’m scared. I’ve been taking this NDMA for years! And I’ll spare you the details, but when you look that drug up it isn’t pretty.

    I called CDC today, and they have an outdated but informative information sheet on NDMA – their Agency for Toxic Substances and Disease Registry (ATSDR). It isn’t pretty either. Someone needs to do something about this. If I had known we were at this much risk, I would have been so much more careful about due diligence on the suppliers. But again, I thought the pharmacies did this!!!

  5. Elaine
    New Jersey
    Reply

    Just learned of the recall of my Solco Valsartan prescription when my sister called to tell me her doctor informed her of it. It has been known since at least July 6 when Hong Kong recalled the Solco Valsartan from mainland China. There was also something about it in The New York Times and CNNm but I missed it. Since I am on an AARP Walgreens Part D drug plan, one would think one of those entities could have informed me. What a disgrace. I used to have enormous fights with the pharmacists about declining 3rd world country drugs, but gave it up when it began to seem that all our drugs are coming from 3rd world countries.

  6. Dette
    Pa
    Reply

    Why did it take 6 to 4 years for this compromise of the drug Valsartan to be found? Where is quality control?

  7. Jackie
    Washington
    Reply

    This is a disgrace. Will our Congress protect us and pass laws to force pharmacies to disclose the origin of their drugs? This is pharmaceutical company greed at its worst.

    Can you explain the comment that laws passed in 2013 prevent lawsuits against these drug manufacturers?

  8. Joseph B.
    Reply

    I just checked my Valsartan and discovered the inscription below the prescription:
    Yellow/oblong/HH343
    Solco HealthCare US

    SOLCO is one of the sources of NMDA mentioned in your report. Was the carcinogen removed following the recall? The only thing I can think of is to ask the Pharmacist if it was.

    • Mitch
      Boca Raton
      Reply

      It absolutely wasn’t removed! You have the tainted version. Replace it right away!

  9. Marie - Sweden
    Sweden
    Reply

    I suppose I belong to a rather unusual group – women over 70 – without any medication.
    I plan to stay that way. Many people have to ask themselves and their doctors: do I really need this medication? Are there any studies that compare people my age with – or without- medication and for longer periods, and who paid for those studies?

    My father was multimedicated and I saw, at an early age, that it was not a good solution but in those days it was difficult to find information because there was no Internet. As of 2003, when my father was drugged at a nursing home in Sweden, I could turn to the Internet. My eyes have been opened by interesting, critical books and articles.

    You can start by reading Joe and Teresa Graedon’s book – Top Screwups that doctors make and how to avoid them. Then continue with for example:
    Too Many Pills (James Le Fanu, UK, just published)
    The Truth About The Drug Companies (Marcia Angell)
    Seeking Sickness (Alan Cassels)
    Rethinking Ageing (Nortin M. Hadler)
    The risks of prescription drugs (Donald W. Light)
    Are your prescriptions killing you? (Armon B. Neel, a geriactric pharmacist)
    The Patient Paradox (Margaret McCartney – UK)
    Our Daily Meds (Melody Petersen)
    Less Medicine More Health – 7 assumptions that drive too much medical care (Gilbert Welch)
    Doctoring Data (Malcolm Kendrick, UK)
    Ignore the akward (Uffe Ravnskov)
    Overtreated (ShannonBrown Lee)
    Deadly Medicines and Organised Crime (Peter C. Götzsche)

    The writers come from different countries but they all write in English. If you want to know more about the writers and the books – please google. Some have also made videos.

  10. c
    Reply

    I am wondering why people depend on drugs and not, instead, change their life style to healthier eating and getting exercise. It may seem simpler to take a pill. However, there seem to be too many side effects that are dangerous to life.

  11. Deloris
    Reply

    I hope that readers realize that if anyone develops cancer as the result of taking generic valsartan from these manufacturers, there is no chance of taking them to court, thanks to a 2013 ruling by the US Supreme Court.

    • cheryl
      SK
      Reply

      Are you serious? No compensation if someone developes cancer? What about a class action suit?

    • John
      US
      Reply

      There are people with physical problems that hinder their ability to exercise like the average person. Someone who has none of these ailments can’t seem to relate.

    • carla
      Illinois
      Reply

      What ruling and why wouldn’t anyone be able to sue?

  12. Lucy
    Texas
    Reply

    I called Walmart to see if my Valsartan was on recall list. They said yes and they would replace the 72 pills I had with new Valsartan. What about those who didn’t hear about the recall?

  13. Helen
    Raleigh, NC
    Reply

    I started taking Valsartan October 2013 after my sister and mother both died in the same month, and my blood pressure ran up. In October 2017, I was diagnosed with breast cancer. There is zero breast cancer history in my family, and I have none of the genetic markers for the disease. Is this added carcinogen in my daily prescription what caused my cancer? We may never know. I’m trying to remain calm about it all but I have certainly stopped ingesting this poison.

    • Lauriei
      NY
      Reply

      Did you have Triple negative breast cancer? I also had genetic testing done, and markers came back negative. I started Valsartan in 2014 and got TNBC in 2016.

    • Regina
      Scottsdale, AZ
      Reply

      In January of this year I was diagnosed with breast cancer. I am HER2 Triple Positive. Three years ago, my PCP changed my blood pressure meds to Valsartan. When I received the recall notice from my insurance company, I was already 22 days into the tainted lot. However, I have since learned that SOHO was cited numerous times over the past 4 years for trace amounts of the cancer-causing agent. So the bottom line is, I’ve been taking this tainted stuff for 3 years.

      It wasn’t until this lot was shipped in May that the decision to recall was made because it wasn’t trace amounts but much higher levels. By the time I received the recall notice, I had just finished my 6th and final round of chemo.

      There is no breast cancer in my family on either maternal or paternal side, and this particular type of cancer is NOT genetic. It is however a genetic mutation caused from some outside environmental influence which triggers the receptors.

      I have contacted personal injury attorneys about this and I am being told that the only cancer related to the carcinogen is liver and kidney. They don’t seem to get the issue with HER2 . Currently there are a number of class action suits being filed against the manufacturing facility and the manufacturers but these class actions are related only to liver and kidney cancers. That doesn’t mean a breast cancer patient isn’t susceptible to getting either.

      I intend to keep contacting attorneys to handle my case until I find one intelligent enough to understand why this issue in all probability is my smoking gun.

  14. Vicky
    St Louis
    Reply

    Walgreens refused to take back my new 90 day supply of Valsartan and told me to call the manufacturer. That number is ringing with no answer or busy. I gave up after three days of trying. My doctor switched me to Benicar and it seems ok. The lack of responsibility that these pharmacies are taking regarding their dispensing a medication that they procured from a manufacturer is ridiculous. I have been unhappy with Walgreens for some time and have changed pharmacies since this because of the total lack of regard for the client/patient. Shame on the FDA too!

    • Mary H.
      89061
      Reply

      VICKY, I cringed when I read your post! I switched from Benicar to Valsartan after 12 days in the hospital with dehydration, renal failure, villous atrophy and more supposedly caused by a little known side effect of Benicar! It almost killed me!

      I thought they pulled Benicar off the market! So now I’m so worried because of this new Valsartan recall. Seems as though I can’t win! Benicar is manufactured by a Japanese pharma and now Valsartan by a Chinese pharm. Pick your poisons! Note: Walgreens notified me by mail of this Valsartan recall.

    • Lillian
      LONG ISLAND NY
      Reply

      I too was on valsartan for many years manufactured by solco and developed breast cancer. Further investigation and guidance is needed here

  15. geoff
    UK
    Reply

    You are doing a great job for the patients who have no other voice or means of finding these “anomalies”. Thanks very much.

  16. elaine
    Illinois
    Reply

    I wonder if the brand Diovan has this issue also. If China is using the same API Active pharmaceutical ingredient is also in the brand. What other -sartan medication may have this ingredient or one similar manufactured in the same Chinese plant on the same machines. Maybe Trump should have the Federal government make the drugs here in the states and tell China thanks but no thanks.

  17. jane
    Florida
    Reply

    Took them six years to let us know that China was killing us with Rocket fuel as fillers in our meds …God help us

  18. Kathleen
    Missouri
    Reply

    I have been on Valsartan for several years and have been concerned about its being manufactured in China all this time. Several years ago, I asked my pharmacy for Valsartan manufactured elsewhere and they could not find any other source of it. I seriously doubt that the FDA can monitor the safety of pharmaceuticals being manufactured in China. The Chinese have produced milk that poisoned their own children and dog chews for sale in the U.S. that had to be recalled. How can we ever be assured that what they manufacture is safe? Why in the world does the U.S. have to go to China for medications to treat U.S. citizens other than Big Pharma Greed? P.S. I now have breast cancer.

    • Helen
      Kansas City
      Reply

      I too have been on Valsartan for a number of years and have been found to have uterian and ovarian cancers. These were SEPARATE and unrelated cancers per pathology reviews. This may explain the source of my cancers since I come from a cancer free family history! My family all experience some cardiovascular related death NOT CANCER.

    • carol
      CA
      Reply

      I called the pharmacy where I get my mail-order 3 month supply of Valsartan. I found out their supplier of Valsartan is Olympic Pharmaceuticals ((908) 393-9604. I talked with Olympic to determine their source, and a very helpful rep who did some investigating and said their Formulations “source” is India, and Olympic is not on the recall list. Ii made me wonder about the “global economy”; is it worth it?

    • Laurie
      NY
      Reply

      Just wondering what type of cancer you have? I had Triple Negative.

  19. Doe
    MS
    Reply

    I was shocked about the recall of my Valsartan and more shocked when I learned in was manufactured in China. I took Diovan for years and when it went generic my
    insurance company switched me to Valsartan. I assumed it was manufactured in the US. I blame my insurance for this and also food and drug. We need our medicine manufactured in our country. I would not trust the Chinese as proven with Chinese dry wall and many other things yet our country allows something like medicine to be manufactured in China. We need to get in touch with our senators and congressmen and demand better than this.

    C

    • Olivia
      DE
      Reply

      Please we need to come together and stop this rip off… I’ve also been on China produced drugs, and India recalled drug…. and have had two types of cancer, both rare cells. Thyroid and breast cancers. This is my second recall. Help…. us someone. Im still living but….. I’m wondering if this cancer is from these meds?

  20. Antoon
    New zealand
    Reply

    The comments herein point to the dangers of statin drugs.
    Most diseases can be avoided through your diet, I am in my 86th year and on no prescription medications. As I have said before and I say it again “let your food be your medicine and your medicine be your food”. This should be headlines every day of your life.

  21. Jeanne
    IN
    Reply

    I am wondering how this blood pressure medicine cancer scare relates to an article you posted on August 8, 2013 entitled “Popular Blood Pressure Drugs Raise Cancer Risks?” The “flaw” in our FDA approving and monitoring our medicines appears to approaching a critical point. The fact it takes years to diagnosis some cancers makes it easy for Big Pharma to fall through the cracks and keep making and selling inferior products. This is quite scary to me as a heart patient.

  22. Mary
    Texas
    Reply

    Are brand name drugs made in the USA and can we be assured the FDA checks to see if NDMA is used in making them.

    I believe the relationship between the FDA and drug companies needs to be throughly investigated!

  23. BBB0b
    Amhest, NY
    Reply

    Not to appear to be a “wise guy”, but I had read of a cancer link to valsartan some years ago while looking for a generic version of Avalide, which main ingredient, irbesartan is, I believe, a “kissing cousin” of valsartan, and used for the same purpose, as an angio receptor blocker, to lower blood pressure in a slightly different way that an ACE inhibitor works. As a user of captopril (ACE inhibitor) for many years, I was troubled with the constant cough associated with its use, and my doctor switched me to Avalide (ARB) to see if it would end the coughing problem, which it did.

    Avalide, which was fairly expensive, was, at the time, patent protected, therefore its less costly generic equivalent, Irbesartan/HCTZ had not yet become available. Within a year, however, irbesartan/HCTZ 300/12.5 became available as a generic and I switched to it as a way of obtaining the basic drug at a price which my HMO would approve. In my research, prior to the release of generic irbesartan, I learned of at least two similar “—sartan” drugs, including Valsartan, but delving into their similarities to irbesartan, I read of a study which appeared to link valsartan and another similar “family” drug with a possible higher risk of cancer, so I did not request my doctor to switch me from Avalide until such time as generic irbesartan became available. Despite a slight difference in the amount of HCTZ in the generic, irbesartan/HCTZ 300/12,5 has worked for me quite nicely for several years without the cough associated with the ACE inhibitor..

  24. Susan
    Idaho
    Reply

    I’ve been taking Valsartan for about 8 years. A little over 3 years ago I was diagnosed with colorectal cancer, which I was not genetically predisposed to have, and my doctor called random bad luck! Now I’m wondering if Valsartan caused it! Is there any way I can prove it?!? Underwent treatment, I’m so far cancer free right now.

  25. Joanie
    Cheshire
    Reply

    Once again greed rears its ugly head, I live in the UK and we have NHS which is free healthcare along with our medicines sounds wonderful and yes it is, however, all our drugs are generic and I suffer dreadful side effects from the cheap inactive ingredients they put into them, I can only buy branded drugs if I go to a Dr in private practice and get a prescription from him/her as I am on an awful lot of medicine due to having heart failure and cancer I cannot afford to do so.

    I agree that Country of origin should be on the medicines we have the same problem here with food as members of the EU it just states “produce of the EU” so you havent a clue where it is coming from they harvest vegetables from all around the EU send them to be processed in one Country then packaged in another!

    All mixed in together and when they get contaminated with no traceability! Recently a batch of sweetcorn was found to be full of Listeria the EU knew about it since 2016 said nothing as they could not trace it but since 9 people have died they worked harder and found the source was the processing plant in Hungary.

    It is terrible and our health and lives are being put at risk by these methods of manufacturing. The cause of the Listeria was dirty machinery the veg were also contaminated by the water used to wash the veg before freezing them, We should demand that everything should have the Country of origin made clearly on them, we are at the mercy of the EU and its rules until we leave but America is not I think as I said it is all driven by greed by the drug companies also by the pharmacists all trying to make as much profit as they can

  26. Thomas
    Georgia
    Reply

    What about Valsartan from India? I take Camber 320 mg.

  27. joanne
    ohio
    Reply

    First of all a word to Bob from Pa. above. Be sure to be aware if you develop a cough which is a very common side effect of Lisinopril. As for our Valsartan it was suggested I switch to Losartan but since it is also made by Solco, why even bother to switch. I asked my pharmacist about the brand name Diovan (expensive) and he hinted that there is some talk about the same ingredient in that also. This whole thing is going to cause big delays, shortages, confusion and doubt and a big chance for other Pharmaceutical companies to make a killing with customers switching until such time as their product is recalled. How unfortunate for us all. As for myself, I am just going to continue with Valsartan which i just last week renewed for 3 months, and see what happens when it is time to renew again. I already tried 4 or 5 types which I couldn’t tolerate before finding Valsartan.l Wish I didn’t need BP med but I do.

    • Jeanne
      IN
      Reply

      Oh my! Thanks for the comment about Losartan. I did not realize Losartan [which I am on] is also made by Solco. My pharmacy does not tell where any medicines are made or where they come from. This is not encouraging news. I hope this contamination does not move into other medicines manufactured by this/these companies. It shows what little oversight there is when it comes to making profits. I often feel like a guinea pig for them!

      • Karen,RPh
        WA state
        Reply

        Look carefully at the label on your prescription bottle. Mine from Fred Meyer (sold at Kroger) have the name of the manufacturer just under the drug name. The manufacturer’s name is also on my label from Walgreen’s. In the past sometimes the NDC-National drug code is on the Rx label. This code includes a number that is specific for the manufacturer and the particular drug. Some drug identification apps for smart phones list the manufacturer of the pill or capsule you are looking up.

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