safety concerns

By now you have read a lot about the valsartan recall. Many lots of the common blood pressure pill, valsartan, have been recalled. Initially, the FDA issued recalls for valsartan from just three manufacturers: Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutical Industries (with valsartan labeled as Actavis LLC).

Now the recall has been expanded to include valsartan and combinations of valsartan and hydrochlorothiazide from other companies including Remedy Repack, A-S Medication Solutions and AvKARE.

All of these valsartan products may contain an active pharmaceutical ingredient manufactured in China and contaminated with N-nitrosodimethylamine, or NDMA. This compound is a probable human carcinogen.

How Big Is the Valsartan Recall?

It is hard to get a handle on the immensity of the valsartan recall. The FDA has been fairly tight lipped about how much of this generic drug has been recalled. One expert we consulted suggested that this could be the biggest consumer recall in history.

Valsartan is taken by roughly three million Americans. Millions more take it worldwide.

According to the Globe and Mail, a major Canadian newspaper:

“There were more than 2.5 million prescriptions for the drugs involved in the recall dispensed in Canada last year, according to IQVIA, a company that tracks the pharmaceutical industry. That represents more than half of the total 4.4 million prescriptions dispensed for valsartan drugs in Canada, according to the IQVIA data.”

If half of the valsartan sold in Canada has been recalled, that could mean a huge number of pills have been recalled in the U.S. and Europe as well. Our expert consultant could be right. This could be the greatest consumer recall in history.

FDA Update:

The Food and Drug Administration keeps updating information on the valsartan recall. Since the July 27th update we now have an August 2, 2018, update. In addition to the companies listed above the FDA now states:

“The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:

• Bryant Ranch Prepack Inc.
• H. J. Harkins Company Inc. (this company was not originally included on either list)
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx

“It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.”

How Dangerous Is NDMA?

The FDA acknowledges that:

“NDMA has been found to increase the occurrence of cancer in animal studies.”

The agency goes on to downplay the risk to humans, however.

“Consuming up to 96 nanograms NDMA/day is considered reasonably safe for human ingestioni. It is estimated that over the course of a person’s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime.”

Lest you develop a false sense of confidence, FDA goes on to say:

“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.”

Yikes! Some people may have been swallowing a pill every day for four years that contained a probable carcinogen. The FDA did some calculations and concluded that only one person out of 8,000 would develop cancer as a result of the contaminated valsartan. We’re not so sure about this assessment. We doubt that anyone will be required to actually follow up on the millions of people exposed to contaminated valsartan. Consequently, we may never know how many people were affected by this gigantic manufacturing error.

The FDA’s Final Words of Wisdom:

“Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.”

You can read more about the implications of the valsartan recall at this link:

You may also wish to listen to our radio show about valsartan and other drugs made in China. It will be broadcast initially on August 4, 2018. The podcast will be available on Monday, August 6, 2018 at this link.

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  1. Rosa
    Wisconsin
    Reply

    I’ve been taking tainted valsartan for more than ten years. I just don’t get why the United States of America would trust China with it’s reputation for using poisonous chemicals to manufacture medications for the citizen of America.

    Red flags and sirens should have alerted our government when China exported baby food tainted with glass and lets not forget the poisonous animal treats, among a host of many other dangerous items from that country. This just another example of the importance of cutting cost at the expense of protecting human beings.

  2. Ann
    Florida
    Reply

    I switched from brand name Cozaar to Valsartan 9 month ago. Mine was one of the ones on the recall list. Recently my Uterine biospy showed hyperplasia and my gyn/oncologist recommended a complete hysterectomy, including ovaries and tubes. They are also telling me that just because the bioposy did not show a malignancy does not mean I don’t have cancer and they won’t know till they remove the organs and examine them. As a nurse for 30 years, who leads a healthy lifestyle, I could not be more upset. I blame the Valsartan and find it to be more than a coincidence. Why are we allowing China to poison us?

  3. Judy
    MA
    Reply

    Myself among many others I know just do not understand WHY our drug ingredients are coming from China. They have no regulations on what they use. I have been on Valsartan for several years now. I am so disappointed in many ways with the FDA, they are not doing the job that we trust them with!

  4. Sharon
    Houston
    Reply

    My doctor replaced my ValsartHCT with IrbesartHctz. But the replacement is also manufactured by Solco. How do I know if the replacement is safe?

  5. Janice. c
    N.C
    Reply

    Our government should not allow medications to come in from other countries, especially countries like China.
    I have been taking Valsartanfor many years. God only knows what damage it has done. I would rather die from high blood pressure than cancer.
    Our government is killing us.

  6. Lee
    Illinois
    Reply

    I’d appreciate hearing what alternatives have been offered by individuals’ doctors. I had to reach out on my own to both the pharmacist and doctor. Now I’m being asked to research alternatives.

  7. conway
    Virginia
    Reply

    Have been taking LOSARTAN for about 12 mo., prescribed by my
    primary physician at local VA med center. Is it on the endangered list?
    Big fan of People’s Pharmacy by the way. Thanks.

  8. Rebecca
    Idaho
    Reply

    Is there any information on what Solco or other companies are planning to do to reimburse the costs of recalled Valsartan? I have almost a 3 month supply of the recalled pills and Walgreens would not replace it with a non-recalled med without my co-pay, though they did get permission from my insurance company to refill it early.

  9. Phoebe
    British Columbia
    Reply

    In Canada, there is legislation called the Food and Drugs Act that is supposed to ensure we are protected from “health hazard” in the manufacture and sale of food, drugs and medical devises. Sadly, the regulator Health Canada, responsible for upholding and enforcing it, has not done so adequately for decades. This has gotten worse since deregulation in the 1990’s when the pharmaceutical industry became the “primary” client of the regulator, and citizens were relegated to a lower level on the list of who is important and not so important in regulating prescription drugs in Canada. All of this has been well documented in academic literature for years, and Canada’s Auditor General has raised red flags about this since at least 2000. Thus far, no major changes have occurred.

    It’s time for citizens in both Canada and the US to loudly call for the creation in each country of an arms length, impartial Drug Safety Board which would investigate when these drug disasters occur. It would operate similar to, for example, a Transportation Safety Board as here in Canada. As things stand presently in the case of Valsartan, the regulator will investigate its own failure as will the manufacturers. This may be what the law allows but it has no connection with impartiality, transparency or even a hope for justice and citizens may never know the whole truth. In Canada there is talk of law suits. The courts and its adversarial processes are a poor substitute for a Drug Safety Board made up of impartial experts. I do not believe there are many judges who are also medical researchers/practitioners. Thus they would not have the competence to even understand the medical/pharmaceutical complexities in front of them so wise, deeply considered decisions could be made. As well, while fines/penalties may be ordered (or not) little changes. The leaders in companies keep on doing the same things, as do politicians and regulators. Citizens pay the price, often with their lives. Its time for us to wake up. We need a Drug Safety Board to investigate the Valsartan debacle – now.

  10. Pat
    FL
    Reply

    I find it mind-boggling that our medications are manufactured in other countries without any testing of ingredients before consumption here in the U.S. I hope that this recall prompts U.S. legislation to ensure the safety of our medications. As the only person in my immediate family of seven without a diagnosis of cancer, I am extremely worried now about the three medications I currently take plus over the counter meds and vitamins. I will speak with my doctors about discontinuing use of prescription and over the counter medications not easily verified as being made and inspected in the United States.

  11. Wanda
    CA
    Reply

    My doctors changed my medication and I was just wondering if Losartan-Hctz 50 mg is safe? I was told that 50 mg was the lowest dosage. That was a lie 25 mg is. I have been on it for two weeks and have horrible indigestion, gas, stomach cramps, and bad diarrhea.

    He increased my Metformin to 1000 2x daily.

  12. Penelope
    Florida
    Reply

    Let’s put tariffs on medications from China and consider Puerto Rican pharmacies as domestic production. Bring this production back to America.

  13. Jewel Cox
    NC
    Reply

    I had a stroke before Christmas last year and spent several days in the hospital. My blood pressure was sky high. I am an 88 year old female. I went to a cardiologist.
    He gave me as one of a list of drugs. One was water pill mentioned above. My blood pressure did not come down. An Internal Medicine doctor switched me over to Spironolactone. This is working well for me.

  14. Dorothy
    NC
    Reply

    I have taken Valsartan for a number of years. I have taken the generic from Solco Healthcare for several months. I was diagnosed with breast cancer on June 6, 2018, If this generic added to developing cancer, I do not know. I just think this impure medicine is a scary situation.

  15. Laurence
    Ayr
    Reply

    How about the other ARBs –ie Telemisartin

  16. Nan
    Houston
    Reply

    I found this list of of companies in which Valsartan manufacturing is deemed safe: “Companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero, according to Fore Pharma.” My Briargrove Pharmacy pharmacist assured me that the Mylan I am taking is safe even though it may be manufactured in India.

  17. Nancy
    FL
    Reply

    Mine was one of the ones recalled. I called my pharmacy and they replaced them with another maker… Aurbindo. Apparently, it is not on the list…. yet. It is scary because 2 weeks ago I got a report back from my mammogram saying that I needed a biopsy. The biopsy was done on the breast that never had any issues. The results are; precancerous cells. Recommendation is lumpectomy followed by radiation and a pill. I have been on Valsartan for several years. I am Not a happy camper!

  18. carol
    ga
    Reply

    I might not have known this was recalled except for your notification. My Drs. office did not alert me and my pharmacy said they could not refill and they did send a letter stating the recall. Thank you for your alert because I was the one calling my Drs. office……

  19. Sandy
    Wisconsin
    Reply

    Was it your site that also stated that in 2013 and 15 European countries banned the sale of over 700 generic manufactured medications, including anti-depressants, heart meds and antibiotics because of manufacturing issues. And that our own FDA even as of Dec of 2017 was still allowing these meds to be sold in the US. This issue just keeps proving our Medical/Pharma safety net is not functioning.

  20. Patty
    Maine/Oregon
    Reply

    Big Pharma gets Valsartan from China, instead of manufacturing it in the US, I’m sure because it’s cheaper. Politicians demand that we buy our drugs in the US because they are greedy, and because they say it’s safer for us. I guess they were right all along, about being safer.

  21. Gary
    Texas USA
    Reply

    I would like to know what types of cancers can be promoted with the impurity in Valsartan. The key to beating cancer is early detection and I would like to know what to be on the look out for!

  22. Joseph
    Houston, TX
    Reply

    Wow. This is pretty damned shocking. The “lesson learned” however, is muddled: should we avoid all medications manufactured in China? Should we avoid medications sold under “looser” (????) regulations in Canada? Is this horrible scenario simply a “one off” exception that could have happened anywhere? What exactly is the lesson learned, folks?

  23. Jesse
    Texas
    Reply

    I don’t see how we can ever trust pharmaceuticals and supplements not to be harmful and contaminated.

  24. Rose
    Buffalo ny
    Reply

    Why can’t we use ingredients from the USA to make these drugs. Why are we dealing with China and India for ingredients?

  25. Mar
    Jersey
    Reply

    How did the FDA miss this for so long ? This is unexceptable . Why we would ever buy drugs from a country like China is beyond me. They really don’t give a crap about their own people so to think we are any different is foolish . I have been taking this drug for 7 years. The FDA is asleep at the wheel .

  26. david
    NV
    Reply

    It would be good to know the risk of valsartan with this contaminant compared to familiar risks. Which has more risk, taking valsartan with this contaminant for a year or eating a grilled hamburger once a week?

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