Generic Diovan Recall Issued Over Cancer Risks Worldwide, But Not In U.S.

Nearly two dozen countries worldwide have announced a recall for generic Diovan, indicating that impurities were detected in the hypertension and heart drug that may cause cancer. 

The valsartan recall was announced on July 5, after batches of the active ingredient, supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for N-nitrosodimethylamine (NDMA). The recall affects about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada, but it does not appear the recalled medications were shipped in the United States.

The European Medicines Agency (EMA) issued a press release announcing a safety review of the drugs the same day the worldwide generic Diovan recall was announced.

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Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug.

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“NDMA is classified as a probably 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 wat the active substance was manufactured,” the EMA press release states. “While the review is underway, national authorities across the EU are recalling the medicines containing valsartan supplied by Zhejiang Huahai.”

The review will look at the levels of NDMA found in valsartan and the potential health effects, as well as what can be done for patients who have taken them, and how future contamination can be prevented.

Officials in the U.S. Food and Drug Administration (FDA) have declined to say whether any of the batches were shipped to the United States, and are not recalling any valsartan at this time.

The FDA reviewed Diovan and similar medications in 2010, after some data suggested they may increase the risk of cancer. However, in 2011, the FDA reviewers indicated they could find no link between the drugs, known as angiotensin receptor blockers (ARBs) and cancer.

It is unclear whether the 2010 review and cancer concerns are connected in any way to last week’s recall. Valsartan was originally developed and sold by Novartis, and is now off-patent and sold as a generic.

19 Comments

  • CYRILJanuary 17, 2024 at 10:45 pm

    I have been on Diovan 80 since 2001 and thus far I have had NO adverse health matters. Diovan 160 was recommended for about ONE year in 2010 due to elevated pressures. I took Valsartan 80 off and on whenever the Diovan was unavailable. I am now 76 years of age,

  • LarryApril 25, 2019 at 7:22 pm

    I have been on Diovan 160 12.5 for about 15 years, I did not know there was a recall until this year when I couldn't get my Prescription filled because this medication had been recalled. I was diagnosed with prostate cancer 4 yrs ago. I had my prostate removed and still recovering with the side effects associated with prostate cancer. I am concerned that this medication was a contributing facto[Show More]I have been on Diovan 160 12.5 for about 15 years, I did not know there was a recall until this year when I couldn't get my Prescription filled because this medication had been recalled. I was diagnosed with prostate cancer 4 yrs ago. I had my prostate removed and still recovering with the side effects associated with prostate cancer. I am concerned that this medication was a contributing factor with my Cancer. Please if you have any information concerning this matter, please let me know.

  • MarviaJanuary 3, 2019 at 12:03 am

    Been taking Diovan for years until I was recently advised by my Pharmacist of the drug recall. Scary....

  • Gloria CDecember 11, 2018 at 9:46 pm

    My husband had high blood pressure was taking Diovan/Valsartan since 1972. He died in 2013 of a brain anyerism. Could this medication caused his death?

  • FranciscoAugust 10, 2018 at 6:03 am

    I was just diagnose with pancreatic cancer last year and I shifted to diavan about 2 years ago. I am wondering if there is a relationship. We have no history of cancer in my family. I reside in the Philippines.

  • JanetAugust 3, 2018 at 3:05 pm

    In 2016 I had a partial colectomy. Had a large mass on my colon. Thank God it was not cancer. I have been on this drug for 18 years. Wonder if Valsartan caused the mass?

  • ChrisJuly 31, 2018 at 10:50 pm

    I have also been on Diovan/HCT 320 /25 for at least 15 years. My doctor just found a lump in my throat and my bloodwork came back with many problems. I am really concerned about this. Heard the higher doses were the problem and I take the highest dose.

  • LindaJuly 31, 2018 at 7:56 pm

    My husband took 320m Diovan/Valsartan for several years. He was diagnosed with stage four brain cancer in October 2016 and died in 2017. He was very healthy except for taking high blood pressure medicine. This makes me wonder if it had anything to do with this.

  • GeorgiaJuly 30, 2018 at 11:53 pm

    I have been on Diovan/ Valsartan 160mg. twice a day for almost 25 years. I have just been diagnosed with stomach cancer. My Oncologist is doing a work up right now to determine what stage I'm in. I also would like to particpate in any legal action that may occur.

  • BarbaraJuly 30, 2018 at 8:26 pm

    I have been on Valsartan since 2001. I realize that the recalls have just been since around 2015, but this is really scary for me. I wonder whether this medication has been tainted longer than they are admitting. I have not been diagnosed with any cancer up to this time, but am very concerned that it could develop because of the long term use of this med. I believe that the pharmaceutical comp[Show More]I have been on Valsartan since 2001. I realize that the recalls have just been since around 2015, but this is really scary for me. I wonder whether this medication has been tainted longer than they are admitting. I have not been diagnosed with any cancer up to this time, but am very concerned that it could develop because of the long term use of this med. I believe that the pharmaceutical companies have a responsibility to compensate anyone that has been exposed to this drug. What can consumers do collectively to hold them responsible?

  • KimJuly 30, 2018 at 4:15 am

    I am in the same situation as Richard, I have taken  Valsartan/HCTZ medication distributed by Solco for years and I am very concerned because I have had a brain anyerisum and also had a kidney removed due to having cancer. I am worried since I have had cancer and am prone to it will this by as e a likely affect? If any Law Firms are handling this okay suit please provide information.

  • LarryJuly 29, 2018 at 5:28 pm

    If there is a class actionsuit i would like to join i been taking valsartan for years

  • loiJuly 29, 2018 at 3:39 am

    I have been taking Diovan 40mg, manifactured by Zhejiang Huahai Pharmaceuticals in China, distributed by Solco . I have had Lung Cancer. I have been following at MD Anderson Cancer Center at Houston Texas

  • GregoryJuly 27, 2018 at 4:46 pm

    I am an individual that had been on Valsartan HCTZ 10-320-25 (manufacturer AB Aurobindo) and Valsartan 80 (manufacturer AB Jubilant @ CVS Healthcare) and, 80 &160 MG & Walmart Pharmacy (manufacturer Solco Healthcare) tabs since high blood pressure was detected by my family doctor on August 18, 2015. On May 25, 2017 I was diagnosed to have contracted Primary tonsil squamous fell carcinemo (HCC). [Show More]I am an individual that had been on Valsartan HCTZ 10-320-25 (manufacturer AB Aurobindo) and Valsartan 80 (manufacturer AB Jubilant @ CVS Healthcare) and, 80 &160 MG & Walmart Pharmacy (manufacturer Solco Healthcare) tabs since high blood pressure was detected by my family doctor on August 18, 2015. On May 25, 2017 I was diagnosed to have contracted Primary tonsil squamous fell carcinemo (HCC). After that discovery I submitted to treatment of chemotherapy & radiation; not a pleasant experience. I am now in post therapy stage still dealing with the effects of high blood pressure, sugar diabetes and cancer. I lost ninty pounds from the process, the diabetes seems to have disappeared, although the blood pressure still needs controlled with medication. My medications no longer entail valsartan, as my physician has now prescribed Losartan 100 MG. Hopefully it is a safe medication which arrests the problem. My problem has now been enhanced beyond the pain and suffering of cancer and it’s treatment, to a time of mental anguish because of valsartans use as a medication for my high blood pressure. I personally have contacted Handler, Henning & Rosenberg (717) 238-2000 of Harrisburg, PA to review my legal standing in this evolving circumstance in Healthcare. I would politely suggest anyone with a similar circumstance do the same as facts of this real life scenario continue to appear in attempt to find the answers to their dilemma.

  • DinaJuly 19, 2018 at 6:56 pm

    My mother was on Diovan for years. My father frequently bought medications from Canadian pharmaceutical companies because they couldn't afford their medications otherwise. She died of stage 4 lung cancer last year. Makes me wonder if this had something to do with it.

  • RichardJuly 17, 2018 at 11:28 pm

    I have been taking the Valsartan/HCTZ medication distributed by Solco-- which was manufactured by a chines company- and I am concerned that I could be faced with potential , life threatening cancer -due to exposure to the cancer causing NDMA- which has been found in this recalled medication. I see a class action lawsuit filed in Canada- can you tell me of any firm(s) that may be filing class ac[Show More]I have been taking the Valsartan/HCTZ medication distributed by Solco-- which was manufactured by a chines company- and I am concerned that I could be faced with potential , life threatening cancer -due to exposure to the cancer causing NDMA- which has been found in this recalled medication. I see a class action lawsuit filed in Canada- can you tell me of any firm(s) that may be filing class action suit here in the US-which I could join in? I would like for any future medical costs to be covered by these firms- and also would like to see the FDA in this country- ban any medications from China- or other countries which we have limited control, or supervision over. Any help would be appreciated......this has to investigated- and stopped.....and all patients should be compensated for possible future medical costs. I welcome your response, and any help in forwarding these comments to any law firms that may wish to take this on. Thank you.

  • cindyJuly 17, 2018 at 11:26 pm

    what a scare! I have been on Valsartan for several years now and although it has not been recalled in the US it's still scary. I had endometrosis cancer last year with a full hysterectomy

  • KimberlyJuly 16, 2018 at 7:35 pm

    This is horrible! As a healthcare provider, I appalled that this happens!

  • LauraJuly 13, 2018 at 2:00 am

    Absolutely, awful...

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